Effect of Pre-operative Carbohydrate Loading in Femur Fracture: A Randomized Controlled Trial

doi:10.21203/rs.3.rs-1562294/v1

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Research Article

Effect of Pre-operative Carbohydrate Loading in Femur Fracture: A Randomized Controlled Trial

https://doi.org/10.21203/rs.3.rs-1562294/v1

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posted 19 Apr, 2022

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Background

Femur fracture exhibits a major clinical burden among the elderly people, leading patients to be bedridden for a long time in the hospital. The body is more likely to be in a catabolic state as a result of the prolonged fasting period required for surgery, prominent to an increase in insulin resistance. Pre-operative carbohydrate loading has been shown to improve postoperative outcomes in several countries, however no studies on this topic have yet been reported in Nepal. The aim of the study was to evaluate the effect of pre-operative carbohydrate loading in femur fracture surgery.

Methods

This study was a hospital-based, open-label, two-armed, randomized controlled trial. A total of 66 participants were included in this study and assigned to control group (n = 33) and study group (n = 33). Participants aged 50 years and above were recruited randomly through computer-generated random number between August 2020 and November 2021. Those who underwent femur fracture surgery were enrolled in this study. The pre-operative nutritional status was identified and the post-operative outcomes were measured using the Visual Analogue Score (VAS), Cumulative Ambulatory Score (CAS), and Modified Barthel Index (MBI) score system. Statistical analysis were performed using the Chi-square test and independent t-test to compare between the outcomes between two groups.

Results

All the participants completed the study. The effect of carbohydrate loading showed a significant reduction in the post-operative pain in the study group than that of the control group (4.1 ± 1.8 versus 6.1 ± 2.1, p = 0.010) and higher functional mobility (8.1 ± 2.6 versus 6.8 ± 2.8, p = 0.033). The hospital stay in the study group was also shorter than in the control group (6.7 ± 2.4 versus 8.8 ± 4.5, p = 0.024).

Conclusions

The uptake of carbohydrate loading showed reduced post-operative pain, enhanced functional mobility, and decreased length of hospital stay. This study warrants a revision of current guidelines, which shed more light on the necessity of the provision of pre-operative carbohydrate loading in a clinical setting.

Trial registration: ClinicalTrials.gov identifier: NCT04838366. Registered 9 April, 2021, https://clinicaltrials.gov/ct2/show/NCT04838366

Femur fracture

surgery

Pre-operative

Carbohydrate loading/administration

Nepal

Globally, femur fractures could be considered as the most significant complication relating to the morbid and mortality. It represents one of the leading causes of hospital stay in older people [1]. The annual incidence of femur fracture ranges from 10 to 21 per 1,00,000 in the world [2, 3]. The annual crude hip fracture is 129 per 1,00,000 people aged 50 years in India [4]. It is mostly managed by a surgical procedure that creates stress among both patients and relatives. Moreover, people in older life have multi comorbidities such as type-2 diabetes (15% in adults aged 50–69, and 22% among 70 + years adults) [5], hypertension (44.9%) [6], thyroid disorder (15.9%) [7], osteoporosis (37.3%) [8], malnutrition (2–63% in older people having hip fracture) [1]. These types of age-related diseases make the treatment more risky and complicated.

According to the current protocol for surgery, the patients are kept in a fasting state from midnight to avoid the risk of pulmonary aspiration during surgery which makes the patients physically as well as mental discomfort. This is an old technique that has been carried out for many years. Patients undergo into a catabolic state after surgery, which can worsen the stress response and contribute to insulin resistance, hyperglycemia, and lengthening the recovery period [9]. Prolonged fasting for surgery may create different complications such as distress, confusion, instability, headache, dehydration, electrolyte imbalance, postoperative nausea, and vomiting [10]. Now, a new idea called Enhanced Recovery After Surgery (ERAS) has been introduced, in which patients should be given 50 grams of carbohydrates two hours prior to surgery, a procedure known as carbohydrate loading [11]. This modern approach has many advantages over the traditional practice. Hellstrom et al (2017) found the mean gastric half emptying time in pre-operative carbohydrate loading (study) group and two reference (control) groups among elder people having hip fractures showed no significant difference in gastric emptying time [12]. It justifies the findings of a study that proves the unnecessary of prolonged fasting for surgery [10]. Preoperative carbohydrate loading decreases insulin resistance by up to 50% [13] and improves metabolic functions [14]. In cardiac patients, the use of ERAS resulted in a 35% reduction in postoperative insulin doses [15]. The preoperative carbohydrate loading reduces the expression of Human leukocyte antigen (HLA)-DR on monocytes which decreases the risk of postoperative infection [16] and reduces the intraoperative core body temperature [17]. In addition, it improves muscle function because of the less post-operative protein and nitrogen loss [18], which facilitates wound healing. It improves the recovery rate, and hence decreases the length of post-operative stay at the hospital [19], which brings a smile to the face of patients making them satisfied, and reduces the treatment cost to 15.2% [20]. Similarly, it is also associated with significantly better well-being [21].

In Europe, ERAS is a novel and scientific approach that is mostly used in general surgery and obstetrics, and gynecology [22]. Nutritional support, on the other hand, is less important for patients' fast recovery in most of the orthopedic programs [23]. In Nepal, the traditional approach of administering anesthesia to the patient in prolonged fasting is still in use. To the best of our knowledge, this study is the first of its kind to assess the efficacy of pre-operative carbohydrate loading in a femur fracture. The aim of this study was to assess the effect of pre-operative carbohydrate loading on the improvement of postoperative pain, functional mobility, and the rate of recovery in a femur fracture surgery.

Study design, sample size and setting

This study adhered to the Consolidated Standards of Reporting Trials (CONSORT) 2010 updated guidelines for reporting for RCTs [24] (additional file 1). This study was a hospital-based, open-label, two-armed, randomized controlled trial conducted between August 2020 and November 2021. The study was conducted at the in-patient department of Nepal Orthopaedic Hospital, Kathmandu, Nepal. Nepal Orthopaedic Hospital was selected purposively because it is one of the excellent Orthopaedics and Trauma Care Super-specialty centers in Nepal, with a focus on orthopedics services. According to hospital records, about 10 patients are operated on each day, with one or two cases of femur fracture among them. The patients aged 50 years and above having a femur fracture planned for surgery were enrolled in this study. Patients with pre-existing diabetes (Type 1 or 2), past carbohydrate intolerance, pathological fracture or any suspected pathology, and surgery failure or non-union cases were excluded from the study. These underlying conditions of the patients were assessed by orthopedic surgeon on the basis of patients’ record files and also verified by asking the patient or patient party verbally.

The sample size was determined based on a previous similar study with the primary outcome of this study being the Mean ± SE of Cumulative Ambulatory Score (Study groups Vs Control groups: (12.76 ± 0.33 Vs 12.02 ± 0.32) [21]. Considering this data with taking α level of significance at 5% and power of 80%, the sample size was calculated using a test comparing independent two means using Stata/MP version 14.1 (StataCorp LP, College Station, Texas). The calculated sample size was 60. To take into account with 10% loss through follow-up and dropout, the total sample size was 66 (33 participants in each group).

Randomization

Participants were randomized in a 1:1 ratio and assigned to a study and control group randomly. Individual randomization was performed using a computer-generated random number. Random numbers were kept in an envelope. Upon confirmation of a participant’s eligibility, the next envelope in the sequence was opened, and the treatment allocation was entered on a randomization list. Treatment allocation was done by the principal investigator.

Study Variables

Outcome variables

The primary outcome was to compare the post-operative pain and functional mobility between the study and control groups. Similarly, the secondary outcome was to find out the serum albumin level between two groups. The postoperative pain in 24 hours was measured using the visual analog scale (VAS) scoring system [25]. The Cumulative Ambulatory Score (CAS) was applied to find out the mobility function after surgery [26] and the Modified Barthel Index-Activities of Daily Living (MBI-ADL) was also used to measure independence at the time of discharge from the hospital, ranging the score from 0 to 20 “total dependency”, the higher the score better the self-care activity [27].

Predictor variables

Socio-demographic information of the respondents such as age, sex, Body Mass Index (BMI), occupation, ethnicity, religion, and educational level was collected using a semi-structured questionnaire interview. Nutritional assessments were performed using a mini nutritional assessment (MNA-SF) [28]. Biochemical parameters such as pre-operative hemoglobin and serum albumin were recorded.

Intervention

The admitted patients with femur fractures planned for surgery were taken for study after taking written informed consent. Socio-demographic information included age, sex, residence area, and occupation were recorded. MNA-SF approach was carried out to find out the nutritional status of the participants before surgery as followed by Miu and Lam, 2017 [28]. On the basis of score, patients were categorized as normal nutritional status, at risk of malnutrition, and malnourished (normal if 12–14, at risk of malnutrition if 8–11, and malnourished if < 7 scores). Each patient was assessed after the declaration for surgery. The site of the femur fracture was documented, whether it was a proximal femur fracture, a shaft femur fracture, or a distal femur fracture. It was also indicated if the fracture is open or closed. The patient’s hemoglobin and serum albumin levels were recorded before surgery. Having noted these, the patients were assigned into two groups: the control group and the study group through computer-generated random numbers. As is traditional, the control group was kept fasting from midnight through the next morning. But the study group was intervened with carbohydrate loading as the protocol made by Enhanced Recovery after Surgery (ERAS) [29]. Surgical patients were asked to drink a beverage containing 100 grams of carbohydrate the night before surgery. On the day of surgery, patients drank a beverage containing 50 grams of carbohydrate two hours before surgery under the supervision of a research team member. Bisch et al, 2019 mentioned that the physiological reason to provide the evening dose of carbohydrate beverage is to create glycogen stores in the body and the morning dose is to change the body to a “fed” state [30]. We provided glucose-D (Dabur Nepal Private Limited, Bara, Nepal, (Regd No.: 3506/045/046, Department of Food Technology and Quality Control, DFTQC No.: 01-33-55-03-218). It contains Dextrose Monohydrate 99.4%), Calcium Phosphate (0.6%), Vitamin D (0.0001%). Then the anesthesiologist gave the spinal anesthesia in the operation theater. The intra-operative data were collected such as the time gap of fracture and surgery, duration of surgery, type of surgery, and amount of blood loss. The adverse effect of carbohydrate loading was also noted if appeared during or after surgery. Post-operative hemoglobin and serum albumin level were recorded on the next day of surgery in the morning. The VAS score for pain was also recorded on the 1st post-op day at the same time. Similarly, the CAS score was also be noted on the 1st, 2nd, and 3rd post-operative days to find out the mobility function after surgery. The total score obtained from the CAS indicated the recovery rate. Similarly, the MBI score was also measured to find out the mobility outcome as recovery rate on the day of discharge. Subsequently, all these scoring systems helped to find the association of pre-operative carbohydrate loading with the recovery rate of patients in terms of the well-being of patients and functional mobility as outcome variables which were further evaluated by the length of hospital stay after surgery.

Statistical analysis

The data entry was done using EpiData version 3.0, and analyzed on the basis of the intention-to-treat (ITT) approach using Stata/MP version 14.1 (StataCorp LP, College Station, Texas). The normality of data was assessed using the Kolmogorov-Smirnoff test. Descriptive statistics such as frequency, percentage, mean (standard deviation) was used.

Chi-square and independent-sample t-test were used to compare between the study and control groups. All probability values less than 0.05 at 95% Confidence Intervals (CIs) were considered statistically significant.

Ethical consideration

The ethical approval was obtained from Nepal Health Research Council, NHRC (Reg. Number: 3104). We constituted a Data Safety Management Board (DSMB) consisting of an orthopedic surgeon, dietitian, and statistician. The DSMB members prepared a study-stopping rules and reviewed all the possible effects reported in the study. The respondents were informed about the purpose of this study. When they gave consent, they were recruited as eligible candidates for the study. Written informed consent was obtained from eligible patients. Voluntary informed participation and freedom of refusal at any time during the study were strongly applied without giving reason and fear. Privacy and confidentiality of the collected information were ensured at all levels. The purpose of the study, benefits and harm to the participants were properly explained in simple and understandable terms by the team member of the research. No any financial benefits or burdens concerned with the study were provided to the patients.

Demographic characteristics of the participants

Of 66 participants, 33 participants received 50 grams of carbohydrate in 100 ml of water before two hours of surgery, considered as a study group while 33 participants were in a complete fasting state before preceding midnight. More than half 35 (53.1%) were female and 31 (46.9%) were male. The mean age of the participants was 67.9 ± 12.9 years. In the control group, it was 69.3 ± 13.9 years and that of the study group was 66.4 ± 11.8 years. Likewise, more than two-thirds of the participants (69.7%) were illiterate and largely exhibited unemployed. Most of the socio-demographic factors like age, sex, educational status, occupation, ethnicity, religion, ecological region, and place of residence whether from the rural or urban region did not show a significant difference between the control group and study group (Table 1).

Table 1

Socio-demographic characteristics of participants
Variables	Total	Control group (n = 33)	Study group (n = 33)	P-value¹
Variables	n (%)	n (%)	n (%)	P-value¹
Sex Female Male	35 (53.1) 31 (46.9)	16 (48.5) 17 (51.5)	19 (57.6) 14 (42.4)	0.459
Age categories 50–70 71–96	36 (54.5) 30 (45.5)	15 (45.5) 18 (54.5)	21 (63.6) 12 (36.4)	0.138
Age in years (mean + SD)	67.9 + 12.9	69.3 + 13.9	66.4 + 11.8	0.179
Education Literate Illiterate	20 (30.3) 46 (69.7)	7 (21.2) 26 (78.8)	13 (39.4) 20 (60.6)	0.108
Ethnicity Advantage ethnic group Disadvantage ethnic group	31 (46.9) 35 (53.1)	18 (54.5) 15 (45.5)	13 (39.4) 20 (60.6)	0.218
Religion Hindu Non Hindu	47 (71.2) 19 (28.8)	27 (81.8) 6 (18.2)	20 (60.6) 13 (39.4)	0.057
Occupation Employed Unemployed	7 (10.6) 59 (89.4)	4 (12.1) 29 (87.9)	3 (9.1) 30 (90.9)	0.500
Ecological region Hill Mountain Terai	22 (33.3) 30 (45.5) 14 (21.2)	12 (36.4) 12 (36.4) 9 (27.2)	10 (30.3) 18 (54.5) 5 (15.2)	0.283
Place of residence Rural Urban	40 (60.6) 26 (39.4)	17 (51.5) 16 (48.5)	23 (69.7) 10 (30.3)	0.131
¹denotes chi-square test or Fisher’s exact test

Clinical assessment of the participants

The majority of participants had proximal femur fractures (63.6%) such as the neck of femur fracture, inter-trochanteric fracture, sub-trochanteric fracture followed by the shaft of femur fracture (24.2%) and distal femur fracture (12.2%). Similarly, the majority of fractures (87.9%) were treated by open reduction and internal fixation (ORIF), which were mostly operated with plating than nailing and other approaches. Most of the patients (71.2%) were at risk of malnutrition (66.7% in the control group and 75.7% in the study group). However, there were no significant differences between the control group and study group regarding the clinical parameters like the site of fracture (Proximal femur, shaft of femur, or distal femur), fracture side (Left or Right), number of bone involving fractures, types of surgery (closed reduction vs open reduction), types of implants used (Nailing, plating or others), amount of blood loss, blood transfusion and pre-nutritional status (Table 2).

Table 2

Clinical parameters of participants
Variables	Total	Control group	Study group	P value¹
Variables	n (%)	n (%)	n (%)	P value¹
Fracture site Distal femur Proximal femur Shaft of femur	8 (12.2) 42 (63.6) 16 (24.2)	4 (12.1) 20 (60.6) 9 (27.3)	4 (12.1) 22 (66.7) 7 (21.2)	0.933
Fracture Side Left Right	35 (53.1) 31 (46.9)	15 (45.5) 18 (54.5)	20 (60.6) 13 (39.4)	0.218
Number of fractures Two or more Single	7 (10.61) 59 (89.9)	4 (12.1) 29 (87.9)	3 (9.1) 30 (90.9)	0.500
Type of surgery Open reduction Closed reduction	58 (87.9) 8 (12.1)	30 (90.9) 3 (9.1)	28 (84.8) 5 (15.2)	0.354
Surgery type (Implants) Nailing Others Plating	18 (27.3) 1 (1.5) 47 (71.2)	9 (27.2) 1 (3.1) 23 (69.7)	9 (27.3) 0 24 (72.7)	1.000
Surgery duration Less than one hour More than one hour	5 (7.6) 61 (92.4)	4 (12.2) 29 (87.8)	1 (3.1) 32 (96.9)	0.178
Blood loss Less than 500 ml More than 500 ml	57 (86.4) 9 (13.6)	26 (78.8) 7 (21.2)	31 (93.9) 2 (6.1)	0.074
Blood transfusion No Yes	56 (84.9) 10 (15.1)	26 (78.8) 7 (21.2)	30 (90.9) 3 (9.1)	0.152
Surgery complication No Yes	64 (96.9) 2 (3.1)	33 (100) 0	31 (93.9) 2 (6.1)	0.246
Nutritional status Malnutrition Risk of malnutrition Normal	13 (19.7) 47 (71.2) 6 (9.1)	7 (21.2) 22 (66.7) 4 (12.1)	6 (18.2) 25 (75.7) 2 (6.1)	0.732
¹denotes chi-square test or Fisher’s exact test

Bio-chemical parameters of the participants

The mean pre-operative hemoglobin level in the control group vs the study group was 11.2 ± 1.1 and 11.0 ± 1.2, respectively. After surgery, the change in hemoglobin levels in the control and study groups were 9.9 ± 1.2 and 9.9 ± 0.9, respectively. Similarly, the pre-operative serum albumin in the control and study groups were 3.3 ± 0.4 and 3.4 ± 0.3 which were changed to 3.1 ± 0.4 and 3.4 ± 0.5, respectively after surgery, with statistically significant (Table 3).

Table 3

Comparison of biochemical and nutritional parameters between the control group and study group.
Variables	Total	Control group	Study group	P value²
Variables	Mean ± SD	Mean ± SD	Mean ± SD	P value²
Preoperative Hemoglobin level gm/dL	11.2 ± 1.2	11.2 ± 1.1	11.0 ± 1.2	0.257
Postoperative Hemoglobin level gm/dL	9.9 ± 1.1	9.9 ± 1.2	9.9 ± 0.9	0.500
Preoperative albumin level gm/dL	3.4 ± 0.4	3.3 ± 0.4	3.4 ± 0.3	0.602
Postperative albumin level gm/dL	3. 3 ± 0.5	3.1 ± 0.4	3.4 ± 0.5	0.005*
Nutritional status	20.4 ± 2.7	20.6 ± 2.9	20.3 ± 2.5	0.655
²independent t-test; *denotes statistically significant at p < 0.05

Primary outcomes after carbohydrate loading

After measuring the VAS score after 24 hours, the pain was significantly reduced in the study group (4.8 ± 1.8) compared to the control group (6.1 ± 2.1). The cumulative ambulatory score (CAS) showed a significant improvement in functional mobility of participants in the study group (8.1 ± 2.8) compared to the control group (6.8 ± 2.8). The mean modified Barthel Index (MBI) at the time of discharge of the patient from the hospital was 11.8 ± 3.1 and 13.1 ± 2.3 in the control and study groups, respectively. The length of hospital stay from the day of surgery was found to be less in the study group than that of the control group (6.7 ± 2.4 vs 8.8 ± 4.5 days) (Fig. 2 and Table 4).

Table 4

Comparison of primary outcomes between the control group and study group.
Variables	Total	Control group	Study group	P value²
Variables	Mean ± SD	Mean ± SD	Mean ± SD	P value²
VAS pain score	5.5 ± 2.1	6.1 ± 2.1	4.8 ± 1.8	0.010*
CAS score	7.5 ± 2.8	6.8 ± 2.8	8.1 ± 2.8	0.033*
Length of hospital stay	7.8 ± 2.5	8.8 ± 4.5	6.7 ± 2.4	0.024*
Modified Barthel Index (MBI)	12.5 ± 2.8	11.8 ± 3.1	13.1 ± 2.3	0.027*
²independent t-test; *denotes for statistically significant at p < 0.05

Carbohydrate loading had no adverse effects in our study, which is consistent with prior findings [31, 32]. According to Loodin and Hommel, the carbohydrate loading reduced post-operative complications associated to hip fracture by 50% [33]. In this study, one participant experienced hypoglycemia during surgery, which was managed by the attending anesthesiologist in Operation Theater. A systematic review by Sebranek et al, 2013 has mentioned that the alterations in blood glucose might be multifactorial and other modifiers may be concerned with its homeostasis [34].

Pain reduction in postoperative patients is a good indicator of their overall wellbeing. This research showed that carbohydrate loading significantly reduced post-operative pain, which is in line with previous findings [21, 35].

The evaluation of functional mobility following femur fracture surgery is another important outcome. We assessed the cumulative ambulatory score for 1st, 2^nd, and 3rd post-operative days. The CAS score of the study group was significantly higher than that of the control group. This finding is consistent with the study of Chada et.al in India [21]. According to Bisch et al, preoperative carbohydrate beverages helps to store glycogen in the muscle enhancing the performance among athletes [30] and ultimately it prevents the loss of lower limb mass leading to better postoperative recovery [17].

The MBI scoring system evaluates the activities of daily living (ADL) based on the degree of assistance required to perform the task after a stroke or surgery [36]. Our study found a higher value of MBI-ADL index score in the study group than that of the control group. Ping et, al (2021) also found a dramatically higher Barthel score of self-care ability among the elderly patients with the ERAS approach in the case of total hip replacement surgery [22].

Due to the occurrence of a more catabolic state during the surgery period, there occurs the destruction of many important inorganics as well as organic elements (for example nitrogen and protein loss) in the body, altering the speed of wound healing [37]. One of them is the decrement of serum albumin, commonly observed in most patients [38] which is the result of intense surgical stress predicting increased postoperative complications [39]. The present study found that the preoperative carbohydrate prevented the decrease of serum albumin in the body during surgery. Serum albumin has several physiological functions and the determined serum albumin reflects the physical or health status, predicting the prognosis [40]. The decrease of serum albumin after surgery is the marker for surgical stress that delays the outcome of the patients which is ultimately related to the long stay in the hospital [41].

The length of the post-operative stay at the hospital is another way of measuring the outcome of patient progress. This study revealed the decrease in hospital stay with carbohydrate loading supported by different studies [19, 20, 42–44]. Amer et. al found that pre-operative carbohydrate drinks reduce the length of postoperative stay at hospipital from 0.4 to 0.2 days compared with fasting [45]. Kotfish et al, 2020 found a 50% reduction in the length of ICU stay after cardiac surgery [15].

Our study had few limitations. We could not evaluate the insulin resistance due to the high cost of the test and the lack of availability of laboratory tests at the study site. Furthermore, on the basis of the American Society of Anesthesiologists (ASA), the patients' medical co-morbidities could not be analyzed to rule out the severity of their health [46], which affects the rate of recovery. Besides these, the data were collected at the time of 1st wave of the COVID-19 pandemic that heavily affected all sectors physically, mentally, and socially and of course, exaggerated the data collection process.

Pre-operative carbohydrate loading in femur fractures accelerates recovery rate in terms of post-operative pain and ambulatory function, shortening hospital stay. This study warrants to concern authority to comply with the ERAS guidelines for quick patient recovery in the Nepalese context. Further research can be conducted using beverages that contain carbohydrates, fat, protein, and other micronutrients to acquire additional desired post-operative outcomes.

ADL = Activities of Daily Living

ASA = American Society of Anesthesiologists

BMI = Body Mass Index

CAS = Cumulative Ambulatory Score

DSMB = Data Safety Management Board

ERAS = Enhanced Recovery After Surgery

VAS = Visual Analogue Score

MBI = Modified Barthel Index

MNA = Mini Nutritional Assessment

NHRC = Nepal Health Research Council

ORIF = Open Reduction and Internal Fixation

Ethical approval and consent to participate

The ethical approval was obtained from Nepal Health Research Council, NHRC (Reg. Number: 3104). Participants were recruited under study only after taking their consent.

Consent for publication

All subjects agreed to publish their data.

Availability of data and materials

The data that supports the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restriction.

Competing interests

The authors declare that they have no competing interest.

Funding

This research was carried out under the funding provided by NHRC under the Provincial Research Grant (Grant number: 110/2021).

Authors’ contributions

All the authors contributed in manuscript preparing and editing. NKC, DRSu, RS and MK: conceptualization, study design, methodology application, data curation, formal analysis, data interpretation, software utilization, project administration, validation, writing report, writing manuscript and editing. NKC: Recruitment, intervention, data collection, outcome assessment, drafting manuscript and critical revision. MNT, AG, SB, PK and KKB: Methodology application, data curation, project administration, validation and editing. DRSu and DRSi: critical review, editing, and overall monitoring and supervision. All authors have read and approved the manuscript.

Acknowledgements

We would like to heartily thank the administration, doctors, nurses and technicians of Nepal Orthopaedic Hospital, Kathmandu, Nepal who cooperated in data collection, and of course, to those patients who trusted us and took part in the completion of this task.

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No competing interests reported.

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Effect of Pre-operative Carbohydrate Loading in Femur Fracture: A Randomized Controlled Trial

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Abstract

Figures

Introduction

Methods

Study design, sample size and setting

Randomization

Study Variables

Outcome variables

Predictor variables

Intervention

Statistical analysis

Ethical consideration

Results

Demographic characteristics of the participants

Clinical assessment of the participants

Bio-chemical parameters of the participants

Primary outcomes after carbohydrate loading

Discussion

Conclusion

Abbreviations

Declarations

References

Competing Interests

Supplementary Files

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