bupivacaine , pethidine and sole pethidine on the hemodynamic status and duration of sensory and motor block: A randomized clinical trial in iran

doi:10.21203/rs.3.rs-1913797/v1

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bupivacaine , pethidine and sole pethidine on the hemodynamic status and duration of sensory and motor block: A randomized clinical trial in iran

https://doi.org/10.21203/rs.3.rs-1913797/v1

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Background

Management of analgesia and hemodynamic status is essential for orthopedic surgery patients. This study aimed to determine the effect of intrathecal (bupivacaine + magnesium sulfate) versus (pethidine + magnesium sulfate) and sole pethidine on the hemodynamic status and onset and duration of sensory/motor block in patients with lower limb fractures.

Methods

This double-blind randomized clinical trial was done between October 2020 and August 2021 in the Gorgan 5thAzar^, Hospital, northeastern Iran and included 120 patients undergoing orthopedic surgery with spinal anesthesia and divided them in four groups of A: bupivacaine (10 mg), B: (pethidine 1 mg / kg), C: (bupivacaine 10 mg + magnesium sulfate 100 mg), and D: (pethidine 1 ‌mg / kg + magnesium sulfate 100 mg). The recorded parameters were hemodynamic parameters, time of onset, and duration of sensory/motor block.

Results

There were no clinically significant differences in hemodynamic parameters between the groups. The onset of sensory block (P = 0.235), the onset of motor block (P = 0.097), and the duration of motor block (P = 0.135) were not statistically different between the groups; however, there was a significant difference in the duration of sensory block between the groups (P = 0.035). Magnesium sulfate increased the duration of motor block in the pethidine group C (80.93 ± 30.28) and decreased it in the bupivacaine group D (75.23 ± 38.56).

Conclusions

The intrathecal drugs used in the study did not cause any specific side effects. Therefore, these drugs can be used interchangeably. Magnesium sulfate, in combination with bupivacaine reduced the duration of sensory/motor block. While in the pethidine group, it acted as suitable analgesia by increasing the duration of sensory block. Therefore, magnesium can be considered a suitable additive for intrathecal pethidine.

Trial registration: Iran clinical trial register: (IRCT20170413033408N3) Registration date: 2020-06-11

Spinal Anesthesia

Magnesium Sulfate

Pethidine

Bupivacaine

Anesthesia in orthopedic surgery is a challenging procedure that can effect on patients’ pain, hemodynamic condition and other postoperative complications (1). Regional anesthesia is a preferred approach for lower abdominal/limb surgeries, due to its low potential side effects and drug consumption (2). Recently, using intrathecal anesthetics, in combination with adjuvant drugs, has been increased. The reason is to prolong the motor and sensory block time as pain management, hemodynamic stability, and patient satisfaction (3, 4). Bupivacaine is widely used for spinal anesthesia (5). Various drugs such as epinephrine, clonidine, neostigmine, opioids, and magnesium sulfate have been utilized as the main adjuvant drugs in spinal anesthesia (6).

Magnesium sulfate as an intrathecal drug can improve postoperative analgesia (2). It is an NMDA antagonist that reduces central sensitization. These receptors are activated by surgical stimulus (7). Studies demonstrated no significant side effects in intrathecal magnesium sulfate injection (8, 9). However, one systematic review reported the need for further studies on the role of magnesium sulfate in determining analgesic efficacy for orthopedic surgery (10). Wang (2020) reported that combining small doses of non-opioid drugs such as magnesium sulfate with opioids in spinal anesthesia could have several benefits (7).

Pethidine is a lipophilic opioid with local anesthetic effects (3) that can be used only intrathecally in spinal anesthesia (11). Pethidine is the only opioid with properties similar to local anesthetics and can be used in lower limbs, perineum, and lower abdominal surgeries (12). In developing countries, because of the limitation of resources, pethidine is a drug with a lower price and more availability than local anesthetics and can be an appropriate alternative in most surgeries under spinal anesthesia (13).

This study aimed to determine the effect of intrathecal (bupivacaine + magnesium sulfate) versus (pethidine + magnesium sulfate) and sole pethidine on the hemodynamic status and the onset and duration of sensory/motor block in patients with lower limb fractures.

This study is a double-blind, randomized clinical trial registered in Iran's clinical trial registrar (IRCT20170413033408N3) Registration date: 2020-06-11. After receiving approval from the Ethics Committee of the Golestan University of Medical Sciences, Iran, with the code IR.GOUMS.REC.1398.400, the study was conducted between October 2020 and August 2021 in the Gorgan 5thAzar^, Hospital, northeastern Iran. This hospital is a referral center for candidates for orthopedic surgery in the west of the Golestan province.

A total of 120 patients undergoing orthopedic surgery with lower limb fractures participated in the study. The inclusion criteria were patients undergoing orthopedic surgery with lower limb fractures and spinal anesthesia, no infection at the site of needle entry, no pelvic fracture, age between 18 and 60 years, class 1 or 2 of the American Society of Anesthesiologists (ASA = I, II), no allergy to drugs such as pethidine, and a supine position in surgery.

The exclusion criteria were changing the method of anesthesia during surgery, changing patient position during surgery, loss of consciousness after spinal anesthesia, agitation after anesthesia, and uncooperative after anesthesia for precise evaluation.

Sampling

The participants were included in the study based on simple random sampling. A computer-generated random table was used to allocate patients into four groups: A: bupivacaine, B: sole pethidine, C:‌‌ bupivacaine + magnesium sulfate, and D: pethidine + magnesium sulfate. The table of random numbers was used to generate numbers placed on syringes containing the study drugs. Only one researcher who was not directly involved in drug administration and scoring of the patients was aware of the actual content of any given syringe. This procedure provided allocation concealment that blinded both the patients and statistical analysis.

Data Collection

After explaining the study method and obtaining written consent from the participants, the study was performed.

Patients received druges inthertecally in group A: bupivacaine (10 mg), group B (bupivacaine: 10 mg + magnesium sulfate: 100 mg) (14), group C: (pethidine: 1 mg / kg + magnesium sulfate: 100 mg) (15, 16), and group D: pethidine: 1 mg / kg (15, 16).

Drug injection volume was the same in all the groups. One anesthesiologist performed an intrathecal injection in L3-L4 space with a 25 gauge Quincke needle. Immediately after spinal anesthesia, the patients were placed in the supine position. All the patients were fasting 8 hours before the start of anesthesia. During anesthesia and in the recovery room, 4 liters per minute (LPM) oxygen therapy was administered through a simple face mask. All the participants received 5cc/kg of normal saline crystalloid 0.09% at baseline before intrathecal injection. In hemodynamic disorder, ephedrine was used at a dose of 5 mg to a maximum of 20 mg.

The level of sensory block was checked using a fine needle. Adequate sensory block was assessed as no pain with a fine needle. The onset of motor block was assessed using the Bromage scale (1, inability to move the legs; 2, only move the legs; 3, only move the knees; and 4, complete bending of the knees and legs). The duration of motor block was recorded immediately after drug injection into the spinal cord until the motor block level stabilized. An adequate motor block was regarded as a complete motor (17). We recorded the onset of sensory and motor block using a digital timer. When the patients were transferred to the post-anesthesia care unit, sensory/motor block was continuously assessed, and a research team member recorded the block duration.

The hemodynamic criteria (heart rate, systolic, diastolic, and mean arterial BP (MABP), and oxygen saturation (SPO2)) were recorded with patient care monitoring equipment (SAADAT brand) every 5 minutes for four times and then every 10 minutes up to 60 minutes. The physiological parameters at the time of entry into and exit from recovery were also recorded.

The incidence of pruritus and nausea vomiting in the patients was recorded using a checklist based on the patient's statement and the researcher's observation every 5 to 10 minutes up to 60 minutes and at the time of entry into and exit from recovery.

In case of pruritus was controlled with low doses of propofol (10-20 mg).

In case of nausea and vomiting, atropine (0.6 mg) or ondansetron (4 mg) was used according to the patient's condition.

Data analysis

The analysis of this study was performed using statistical software SPSS version 18. The normality of variables was evaluated with the Kolmogorov-Smirnov test. The three groups were compared using one-way ANOVA or Kruskal-Wallis test to measure the mean of the variables. The repeated measure test was used to evaluate the follow-up of variables at different times. The relationship between qualitative variables was analyzed using the Chi-square test and Fisher's exact test. Data are presented as mean ± SD and median with a range or number of cases. A P value <0.05 was considered statistically significant.

A total of 120 patients were selected for this study (Fig. 1). There were no significant differences in demographic characteristics between the four groups (Table 1).

Table 1: Baseline patients’ characteristics in groups
variables	A bupivacaine		B pethidine		C bupivacaine + magnesium sulfate		D pethidine + magnesium sulfate		P-Value
Age(year)	41.76 ± 13.99		40.80 ± 17.54		37.56 ± 16.71		40.80 ± 14.12		0/59*¹
Weight (Kg)	76.00 ± 14.58		68.26 ± 13.90		72.53 ± 15.71		72.53 ± 13.09		0/31*¹
Gender	76.7% (23) man	23.3% (7)Woman	73.3% (22) man	26.7% (8)Woman	46.7% (27) man	10% (3)Woman	83.3% (25) man	16.7%% (5)Woman	0/36*²
Addiction	40.0%(12) Yes	60.0%(18) No	36.7%%(11) Yes	63.3% (19) No	46.7%(14) Yes	53.3% %(16) No	40.0%(12) Yes	60.0%(18) No	0/88*²

Sensory block level

There was no significant difference in the sensory block level between the four groups) P = 0.41 (Table 2).

Table 2

Frequency of patients in measurement of sensory block level
Level	A bupivacaine	B pethidine	C bupivacaine + magnesium sulfate	D pethidine + magnesium sulfate
T4-T6	6.7%(2)	6.7%(2)	3.3%(1)	3.3%(1)
T6-T8	13.3%(4)	20.0%(6)	16.7%(5)	33.3%(10)
T8-T10	46.7%(14)	63.3%(19)	60.0%(18)	46.7%(14)
T10-T12	33.3%(10)	10.0%(3)	20.0%(6)	16.7%(5)

Hemodynamic parameters

There was no statistically significant difference between the groups in systolic and diastolic BP (Table 3) and the heart rate (P = 0/181) (Fig. 2).

Table 3

Mean ± SD of hemodynamic parameters
BP Systole (mmg)					BP Diastole (mmg)
Time/Minute	A	B	C	D	A	B	C	D
Base	137.53 ± 17.196	132.46 ± 14.08	129.20 ± 27.67	131.06 ± 19.57	83.30 ± 16.59	77.0 ± 11.81	82.56 ± 15.94	82.83 ± 11.19
5	127.70 ± 21.04	119.66 ± 18.55	122.80 ± 17.0	123.40 ± 21.06	78.0 ± 14.88	69.53 ± 13.49	74.63 ± 17.02	73.40 ± 13.51
10	123.93 ± 24.61	110.53 ± 16.99	119.50 ± 15.81	117.16 ± 18.24	75.90 ± 13.59	66.68 ± 12.13	70.40 ± 11.80	69.1 ± 12.98
15	126.03 ± 18.77	126.03 ± 16.19	119.36 ± 13.50	113.06 ± 18.59	77.33 ± 11.01	65.2 ± 13.30	67.83 ± 10.35	67.06 ± 13.15
20	127.33 ± 18.42	108.89 ± 13.63	118.03 ± 14.46	112.50 ± 19.58	76.73 ± 12.42	62.21 ± 13.34	68.55 ± 9.89	65.16 ± 12.21
25	125.78 ± 20.60	110.07 ± 14.59	122.0 ± 14.96	112.41 ± 14.74	78.82 ± 11.59	65.46 ± 16.83	71.92 ± 10.98	67.44 ± 9.32
30	129.16 ± 20.05	108.40 ± 15.95	122.14 ± 15.47	108.07 ± 18.65	79.60 ± 11.49	60.07 ± 13.27	72.77 ± 10.15	63.03 ± 13.26
45	131.08 ± 18.75	112.00 ± 13.56	121.0 ± 16.32	112.92 ± 16.15	78.33 ± 11.25	66.37 ± 12.02	74.61 ± 10.27	68.0 ± 13.88
60	135.50 ± 19.82	115.25 ± 16.56	127.27 ± 18.95	154.41 ± 205.90	81.47 ± 13.01	70.3 ± 14.0	77.50 ± 12.45	66.73 ± 17.08
RE	128.46 ± 16.30	115.26 ± 17.25	127.66 ± 18.15	121.13 ± 19.22	78.83 ± 10.50	71.93 ± 13.3	80.66 ± 12.86	74.03 ± 12.44
RD	126.30 ± 15.84	120.06 ± 12.19	126.13 ± 13.36	120.86 ± 14.72	77.56 ± 11.91	75.63 ± 11.89	79.93 ± 11.92	73.0 ± 11.0
Total	10.98 ± 2.12	11.37 ± 1.09	10.59 ± .91	11.95 ± 1.49	69.99 ± 9.94	76.93 ± 9.86	70.19 ± 8.59	79.16 ± 8.83
P = 0/579					P = 0/059
Mean ± SD SPO2					Mean ± SD MAP and Heart Rate
Base	98.36 ± 2.32	98.33 ± 2.03	99.6 ± 1.49	92.16 ± 24.56	88.06 ± 17.48	91.13 ± 14.49	90.50 ± 20.07	91.06 ± 14.48
5	98.56 ± 2.23	98.2 ± 2.2	99.23 ± 1.54	88.83 ± 29.60	85.33 ± 17.06	87.60 ± 11.14	88.40 ± 21.61	91.96 ± 19.27
10	98.53 ± 3.21	98.03 ± 1.99	103.2 ± 19.31	91.93 ± 24.51	80.46 ± 17.94	83.90 ± 13.39	87.40 ± 23.22	93.56 ± 21.55
15	98.8 ± 2.23	97.63 ± 2.38	100.13 ± 4.84	91.66 ± 24.46	81.66 ± 14.77	82.76 ± 19.50	83.63 ± 21.15	94.06 ± 19.72
20	98.63 ± 2.82	97.82 ± 2.8	100.17 ± 3.94	91.66 ± 24.47	81.43 ± 14.67	81.39 ± 14.27	78.93 ± 22.84	87.76 ± 19.40
25	98.89 ± 2.45	97.75 ± 3.25	99.64 ± 1.47	91.55 ± 24.89	79.85 ± 11.83	81.89 ± 12.89	82.67 ± 20.77	82.96 ± 15.26
30	95.24 ± 18.15	98.14 ± 2.69	99.44 ± 1.31	91.60 ± 25.39	78.12 ± 13.6	79.62 ± 12.56	77.96 ± 17.32	81.78 ± 14.77
45	98.4 ± 3.08	98.13 ± 2.51	99.19 ± 1.23	91.39 ± 25.42	80.22 ± 13.81	78.08 ± 12.90	76.46 ± 14.98	80.96 ± 15.93
60	98.61 ± 2.7	98.4 ± 2.28	99.16 ± 1.29	89.47 ± 27.72	78.33 ± 14.35	79.1 ± 14.84	78.16 ± 16.91	84.30 ± 13.73
RE	98.1 ± 3.83	98.16 ± 2.28	99.16 ± 1.29	89.47 ± 27.72	76.6 ± 13.22	82.93 ± 13.72	79.7 ± 17.42	86.0 ± 16.63
RD	98.1 ± 3.83	98.16 ± 2.08	99.5 ± 1.04	95.1 ± 17.70	75.96 ± 12.38	81.56 ± 12.22	79.03 ± 15.64	82.73 ± 16.2
Total	98.19 ± 3.22	98.46 ± 1.79	99.71 ± 2.22	90.18 ± 25.26	87.37 ± 12.21	94.76 ± 11.83	86.47 ± 8.79	99.74 ± 11.43
RE	98.36 ± 2.32	98.33 ± 2.03	99.6 ± 1.49	92.16 ± 24.56	88.06 ± 17.48	91.13 ± 14.49	90.50 ± 20.07	91.06 ± 14.48
	P = 0/575				P = 0/181

Sensory block

The onset of sensory/motor block and the duration of motor block were not statistically different between the groups. However, there was a statistical difference in the duration of the sensory block (P = 0.035) (Table 4, Fig. 3and 4).

In terms of comparison between the two groups that received bupivacaine (A-C) and the pethidine group (B - D), magnesium sulfate increased the duration of motor block in the pethidine group (80.93 ± 30.28) and decreased it in the bupivacaine group (75.23 ± 38.56).

Table 4

Mean ± SD of sensory block between groups
variables	A bupivacaine	B pethidine	C bupivacaine + magnesium sulfate	D pethidine + magnesium sulfate	*P-Value
Onset of sensory block (second)	61.5 ± 36.48	59.83 ± 88.44	81.16 ± 84.84	54.83 ± 45.09	0.235
Duration of sensory block (minute)	99.26 ± 44.50	69.56 ± 26.49	75.23 ± 38.56	80.93 ± 30.28	0.035

Motor block

There was no significant difference in the onset and duration of motor block between the groups (Table 5)(Figs. 5 and 6).

Table 5

Mean ± SD of motor block between groups
variables	A bupivacaine	B pethidine	C bupivacaine + magnesium sulfate	D pethidine + magnesium sulfate	*P-Value
Onset of motor block(second)	136.8 ± 92.32	127.30 ± 148.22	171.50 ± 128.78	142.17 ± 100.13	.097
Duration of motor block(Minute)	120.8 ± 49.12	117.80 ± 115.41	96.63 ± 43.60	99.85 ± 34.36	0.135

Other complications

Nausea/vomiting and itching frequency were significantly different between the groups. Moreover, 33.3% of patients in group B had nausea and vomiting (P = 0.0001), and 36.7% of patients in group D had itching complications (P = 0.002) from begging spinal anesthesia until recovery discharge (Table 6).

Table 6

Complication between groups (mumber of patients)
variables	A bupivacaine	B pethidine	C bupivacaine + magnesium sulfate	D pethidine + magnesium sulfate	*P-Value
Nausea and Vomiting	2(6.7%)	10(33%)	1(3.3%)	10(33.3%)	*0.001
Itching	2(6.7%)	7( 23.3%)	1(3.3%)	11(36.7%)	*0.002

Sympathomimetic drug usage

There was no difference between the groups in atropine (P = 0.779) and ephedrine (P = 0.144) from begging spinal anesthesia until recovery discharge.

The present study aimed to determine the effect of intrathecal (bupivacaine‌+‌magnesium sulfate) versus (pethidine + magnesium sulfate) and sole pethidine on the hemodynamic status and the onset and duration of sensory/motor block in patients with lower limb fractures. The intrathecal drugs used in the study did not cause any specific side effects. Therefore, these drugs can be used interchangeably.

Our study demonstrated that the combination of magnesium sulfate as an additive to bupivacaine and pethidine was not associated with elevated block levels but could prolong the onset of motor block in groups. On the other hand, it was found that the use of magnesium sulfate in combination with bupivacaine reduced the duration of sensory/motor block. While in the pethidine group, it acted as suitable analgesia by increasing the duration of sensory block.

In this study, we used 100 mg magnesium sulfate as an intrathecal adjuvant intrathecal drug. It was reported that the addition of 100 mg intrathecal magnesium sulfate with heavy bupivacaine prolonged the duration of analgesia (14). Esmaeldin (2018) used (2 ml) of 0.5% heavy bupivacaine plus 0.5 mL (25 µg) fentanyl and magnesium sulfate 0.75 mg (0.5 mL) intrathecally. As a result, the onset of anesthesia was reduced and its duration was prolonged in patients undergoing cesarean section (18). One study including 60 patients with lower limb surgeries under regional anesthesia reported that the duration of sensory/motor block and the duration of spinal anesthesia were prolonged in patients who received 3.0 ml of 0.5% hyperbaric bupivacaine with 0.15 ml of 50% magnesium sulfate compared to other patients who received 3.0 ml of 0.5% hyperbaric bupivacaine. However, hemodynamic parameters and adverse effects were not different between the two groups (19). Another study reported that a combination of magnesium sulfate with bupivacaine in spinal anesthesia had positive effects on increasing analgesia (20).

The dose of pethidine in the present study was based on data from Parmar et al.'s study (2017) (15). It was reported that pethidine provided better postoperative patient comfort and decreased postoperative systemic analgesic consumption (21). In the present study, the hemodynamic status of patients receiving pethidine was stable during surgery until discharge from the recovery room, but the incidence of pruritus and nausea in these patients was more than that in patients receiving bupivacaine. Pethidine has local anesthetic properties, and the addition of intrathecal at a dose of 25 mg prolonged the local anesthetic effect. However, it was associated with more side effects such as nausea, vomiting, and hypotension (11). Hassannasab (2021) reported that using pethidine at a dose of 1mg/kg for spinal anestinthertacally in more than 100 patients for lower limb surgery had hemodynamic stability compared to bupivacaine, and its side effects were not significant. However, the shivering incidence was lower and better after surgery. Generally, this analgesia was significantly superior to local anesthetics (13). Priyanga (2020) reported that intrathecal administration of 10 mg hyperbaric bupivacaine alone and 7.5 mg hyperbaric bupivacaine with 25 mg of hyperbaric pethidine decreased the incidence of hypotension and other perioperative side effects. Also, the intrathecal administration of plain bupivacaine combined with hyperbaric pethidine increased the duration of analgesia compared with hyperbaric bupivacaine alone (3).

Since adjuvants prolong the effectiveness of intrathecal local anesthetic agents (22), it can be concluded that the use of magnesium has been associated with favorable hemodynamic stability. However, in combination with bupivacaine, it has not been desirable due to reduced duration of sensory/motor block for surgery and analgesia. In the pethidine group, magnesium acted as suitable analgesia by increasing the duration of sensory block. Therefore, magnesium can be considered a suitable additive for intrathecal injection of pethidine.

Ethics approval:

The study was conducted by the Declaration of Helsinki and approved by the ethics committee at Golestan University of Medical SciencesIR.GOUMS.REC.1398.400

Informed consent:

All participants were informed that participation is voluntary and reassured that responses would remain confidential. Informed written consent was also obtained from all participants filling in the questionnaires. Participants may withdraw from the trial at any point without any penalty and will not receive compensation for taking part.

Consent for publication:

Not applicable.

Competing interests:

The authors declare that they have no competing interests

Authors' Contribution: SeyedBabak MojaverAghili: study concept and design, and writing the article; Solmaz Halakou: writing the article, data collection, and literature review, Fatemeh Talebi: data collection .Zahra Mehrbakhsh: statistical analysis .najmeh shahini : edit the article and final approval the article

Funding:

This work was a research in the Golestan University of medical science and without any organizational financial support

Availability of data and materials: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Acknowledgment:

The authors would like to thank the department of Research and Technology of Golesatn University of Medical Sciencesand voluntary participation and cooperation of all patients in the study.

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No competing interests reported.

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bupivacaine , pethidine and sole pethidine on the hemodynamic status and duration of sensory and motor block: A randomized clinical trial in iran

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