Dexmedetomidine as an adjunct to local anesthetics in nerve block relieved pain more effectively after TKA: A meta-analysis of randomized controlled trials

doi:10.21203/rs.3.rs-34365/v1

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Dexmedetomidine as an adjunct to local anesthetics in nerve block relieved pain more effectively after TKA: A meta-analysis of randomized controlled trials

https://doi.org/10.21203/rs.3.rs-34365/v1

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Background: Dexmedetomidine showed some potential in pain control in patients undergoing Total Knee Arthroplasty (TKA). Nerve block is a preferable alternative for postoperative analgesia after TKA, on which dexmedetomidine had an effect controversially. This study aimed to meta-analyze the available randomized controlled trials to determine the efficacy and safety of dexmedetomidine as an adjunct to local anesthetics in nerve block after TKA.

Methods: PubMed, Embase, Cochrane Library, Web of science and ScienceDirect databases were searched for the randomized controlled trials (RCTs) meeting prespecified inclusion criteria up to February 1 st , 2020 . The primary outcomes included pain scores, duration of analgesia, total opioids consumption in 24 hours postoperatively, and patient satisfaction. The second outcomes were motor strength, sedation degree and postoperative nausea and vomiting, and other related complications. The methodological quality was assessed by the Cochrane risk of bias tool.

Results: The initial search yielded 143 studies, of which 7 met the inclusion criteria finally. The pooled data indicated that dexmedetomidine combined with local anesthetics in nerve block in TKA could decrease postoperative pain scores at rest (SMD=-1.01[95%CI, -1.29 to -0.72], p<0.01) and at motion(SMD=-1.01[-1.25 to -0.77], p<0.01,), decrease the total opioids consumption within 24 hours(SMD=-0.63[-0.86 to -0.40], p<0.01), prolong the analgesia duration(SMD=0.90[0.64 to 1.17], p<0.01), improve motor strength(SMD=0.23[0.01 to 0.45], p=0.04) and the sedation degree (SMD=0.94[0.70 to 1.18], p<0.01), and increase the patient satisfaction(SMD=0.88[0.60 to 1.17], p<0.01) without adding nausea and vomiting(RD=-0.05[-0.11 to 0.01],p=0.14), and other related complications(RD=-0.01[-0.08 to 0.07],p=0.89), compared with local anesthetics alone in nerve block.

Conclusions: It was effective and safe for dexmedetomidine as an adjunct to local anesthetics in nerve block in TKA to relieve postoperative pain, decrease total opioids consumption, prolong analgesic duration and increase patient satisfaction without increasing related complications. Based on the quality evidence we got, we recommended dexmedetomidine as a regular regimen in nerve block for patients undergoing TKA.

Registration: This meta-analysis was prospectively registered on PROSPERO (International prospective register of systematic reviews) and the registering number was CRD42020169171.

Orthopedics

Orthopedic Surgery

dexmedetomidine

nerve block

analgesia

TKA

TKA is one of the most widely and successfully performed orthopedic surgical procedures for end-stage knee osteoarthritis and rheumatoid arthritis. However, intolerable postoperative pain is one of most annoying and frustrating complications patients and surgeons had to encounter. Previous studies have found that postoperative pain after TKA affected early rehabilitation and psychological state which would delay patient discharge and early rehabilitation, and cause a heavy economic burden(1, 2). Therefore, adequate pain management is very important to reduce morbidity and promote recovery(3).

Nerve block, including femoral nerve block, abductor canal block and epidural block, becomes more and more prevalent in TKA postoperative analgesia for its effectiveness, easy manipulation and rare complications. Local anesthetics such as ropivacaine or bupivacaine are commonly used in nerve block. However, the postoperative analgesia effect and duration of local anesthetics are not so good enough, and delayed ambulation(4) and risk for falling(5) were reported after TKA. To overcome the shortcomings and improve the analgesia effect, more endeavor should be devoted to exploring new agents in nerve block.

Dexmedetomidine is a highly selective, specific, and potent a2-adrenergic receptor agonist, and has sedative, anxiolytic, analgesic, anti-hypertensive, and sympatholytic properties(6). Many surveys had been conducted for its analgesic effect administered in nerve block. However, it is controversial on the postoperative analgesic effect of dexmedetomidine in nerve block after TKA. Thus, a meta-analysis of randomized controlled trials was conducted to evaluate the efficacy and safety of dexmedetomidine as an adjunct to local anesthetics in nerve block after TKA.

Search Strategy

PubMed (Medline), Embase and Cochrane Library from inception to February 1st, 2020 were searched. Additional searching was conducted in Web of science and Science Direct databases. The applied searching string was “dexmedetomidine” AND “block” AND (“knee arthroplasty” OR “replacement”).

Inclusion Criteria

Included studies were considered eligible if they met the Population, Intervention, Comparator, Outcomes, and Study design criteria as follows: Population: Patients were scheduled for primary TKA; Intervention: nerve block using dexmedetomidine combined with regional anesthetics; Comparator: nerve block using regional anesthetics alone; Outcomes: The primary outcomes included the following: the pain scores (including the VAS and the NRS) at rest and movement at different time points postoperatively, the total opioids consumption in 24 hours, the analgesic duration time, and patient satisfaction. Secondary outcomes contained the following: motor strength, sedation degree and the incidence rate of complications, such as the nausea and vomiting, bradycardia and others. Study design: Interventional studies (RCTs). Only published RCT in English were included; the included studies were required to contain at least one outcome. The studies must have had a follow-up rate of at least 80%. Exclusion criteria included observational studies, non-RCTs, review articles, and studies unpublished or in progress.

Data Extraction

A standard data extraction form was used to retrieve the relevant data from eligible articles. The extracted data included first author’s name, year of publication, study location, sample size, study design, gender, population, age, interventions, dosages and type of nerve block, and the randomization and blindness of RCTs. If necessary, the corresponding authors of the included RCTs were contacted to make sure the information was integrated and to get any missing data. Two reviewers extracted the data independently. If there were disagreements between these two authors, consensus was reached through discussion.

Risk of Bias and Quality Assessment

According to the Cochrane Handbook for Systematic Reviews of Interventions(7), the methodological quality and basis of the included literature were assessed as follows: Random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, selective reporting, and other bias.

Statistical Analysis

Statistical Analysis and Data Synthesis were performed with Review Manager Software for Windows (version 5.3). The Standard Mean Difference (SMD) was used to assess continuous outcomes such as pain scores, total opioid consumption, analgesia duration, patient satisfaction, motor strength, and sedation degree with a 95% confidence interval (CI). Risk Difference (RD) with a 95% CI were used to assess dichotomous outcomes. The inverse variance and Mantel-Haenszel methods were used to combine separate statistics. If p values were <.05, the results were considered statistically significant. Statistical heterogeneity of the included studies was evaluated using the chi-square test in accordance with the values of I². I² <50% indicated minor heterogeneity between studies, and a fixed-effects model was used to assess the outcomes. I²between 50% and 100% represented substantial heterogeneity and the random-effects model were used to evaluate these outcomes. subgroup analysis was performed to interpret the potential source of heterogeneity.

Search Result and Risk Assessment

The initial literature search identified 143 articles, of which 135 were excluded because they failed to meet the eligibility criteria or were duplicates. A total of 7 RCTs involving 546 participants were finally included in this meta-analysis(8–14). The PRISMA flow diagram is presented in Fig 1. The evidence quality and risk assessment were evaluated according to the Cochrane Collaboration’s tool for assessing risk of bias. Four RCTs(8, 10, 12, 14) were considered unclear risk of bias because the original protocols were not available. One RCT (11)was considered unclear risk of bias for no descriptions concerning allocation concealment. One RCT(10) was considered unclear risk of bias for no descriptions about blinding to personnel. The results were shown in Fig 2. Totally, no high risk of bias was found in these RCTs.

Study Characteristics

Six of 7 RCTs were randomized and double-blinded with adequate allocation concealment except one single-blinded. All the participants were divided into two main groups: Dex. Group referred the patients received dexmedetomidine combined with ropivacaine or bupivacaine in nerve block, and Con. Group referred the patients received only ropivacaine or bupivacaine in nerve block. All the RCTs were conducted since the year of 2016. Five RCTs explored the femoral nerve block, one explored the adductor canal block, and the rest one explored epidural block. The detailed characteristics of each RCTs were descripted in Additional file 1.

Primary Outcomes

Pain scores

Six studies (8–11, 13, 14) including 496 patients reported VAS or NRS scores at rest or motion. Significant differences were found in postoperative pain scores at rest and motion between Dex. Group and Con. Group (SMD, –1.01[95%CI, –1.29 to –0.72], p<0.01, I² = 89%, Fig 3; SMD, –1.01[95%CI, –1.25 to –0.77], p<0.01, I² = 83%, Fig 4). Significant differences were found in pain scores at rest between the Dex. Group and Con. Group at 6, 12, 24, 48 hours postoperatively, respectively (SMD = –0.87[95%CI, –1.19 to –0.56], P<0.01, I² = 61%; SMD = –0.88[–0.41 to –0.35], P<0.01, I² = 89%; SMD = –0.91[–1.49 to –0.32], P<0.01, I² = 91%; SMD = –1.52[–2.43 to –0.61], P<0.01, I² = 92%). Significant differences were found in pain scores at motion between the Dex. Group and Con. Group at 6, 12, 24, 48 hours postoperatively, respectively (SMD = –0.92[–1.26 to –0.58], P<0.01, I² = 66%; SMD = –0.99[–1.48 to –0.51], P<0.01, I² = 87%; SMD = –0.74[–1.09 to –0.40], P<0.01, I² = 74%; SMD = –1.58[–2.38 to –0.78], P<0.01, I² = 90%). Significant heterogeneity was found in pain scores at rest and at motion for different postoperative time. Thus, a random-effects model was used.

Total opioids consumption in 24 hours postoperatively

Total opioids consumption was recorded in 4 studies (8, 9, 11, 12) containing 336 patients. Pooled data indicated that there were significant differences between these two groups (SMD = –0.63[–0.86 to –0.40], P<0.01, I² = 0%, Fig 5). We used a fixed-effects model because of no heterogeneity between the studies.

Analgesia duration

Analgesia duration was recorded in 3 studies (9, 11, 12) containing 261 patients. Significant differences were found between the Dex. Groups and Con. Groups (SMD = 0.90[0.64,1.17], P<0.01, I² = 0%, Fig 5). A fixed-effects model was used because of no heterogeneity between the studies.

Patient satisfaction

Patient satisfaction was recorded in 2 studies (9, 14) containing 241 patients. Significant differences were found between the Dex. Groups and Con. Groups (SMD = 0.88[0.60 to 1.17], P<0.01, I² = 0%, Fig 5). A fixed-effects model was used because of no heterogeneity between the studies.

Secondary Outcomes

Motor strength

Motor strength was recorded in 2 studies (9, 13) containing 211 patients. Significant differences were found between the Dex. Groups and Con. Groups (SMD = 0.23[0.01 to 0.45], P = 0.04, I² = 48%, Fig 6). A fixed-effects model was used because of minor heterogeneity between the studies.

Sedation degree

Sedation degree for postoperative 24 and 48 hours was recorded in 2 studies(8, 14) containing 165 patients. Significant differences were found between the Dex. Groups and Con. Groups (SMD = 0.94[95%CI, 0.70 to 1.18], p<0.01, I² = 0%, Fig 6). A fixed-effects model was used because of no heterogeneity between the studies.

Nausea and vomiting

Nausea and vomiting was recorded in 3 studies (9, 11, 14) containing 301 patients. No significant differences were found between the Dex. Groups and Con. Groups (RD = –0.05[–0.11 to 0.01], P = 0.14, I² = 0%, Fig 6). A fixed-effects model was used because of no heterogeneity between the studies.

Total complications

Total complications were recorded in 4 studies (9–11, 14) containing 361 patients. No Significant differences were found between the Dex. Groups and Con. Groups (RD = –0.01[–0.08 to 0.07], P = 0.89, I² = 53%, Fig 6). A random-effects model was used because of median heterogeneity between the studies.

Nerve block is one of the most effective analgesic methods which has been widely used in TKA. Local anesthetics such as ropivacacine or bupivacaine are the commonly used agents in nerve block. Dexmedetomidine, a highly selective, specific, and potent a2-adrenergic receptor agonist, is another kind of agents administered in nerve block. Several studies(13, 14) demonstrated that dexmedetomidine combined with local anesthetics in nerve block could improve the postoperative analgesia effect and prolong the duration time after TKA. However, the sizes of these studies were small and the results were not so consistent and persuasive. Therefore, this meta-analysis of RCTs exploring the efficacy and safety of dexmedetomidine as an adjunct in nerve block after TKA was conducted for a greater evidence level and recommendation to clinical practice.

According to the GRADE system(15), pooled data from our meta-analysis found median quality evidence that compared with local anesthetics alone in nerve block, dexmedetomidine combined with local anesthetics could reduce pain scores at rest and motion postoperatively, reduce total opioids consumption, prolong the analgesia duration, increase the patient satisfaction and improve sedation slightly without increasing the risk of nausea and vomiting and other common complications after TKA. Low quality evidence with limited samples found that it could improve motor strength.

The primary outcomes, including pain scores, total opioids consumption and analgesia duration explored the analgesia effect sufficiently with median quality evidence. Our meta-analysis indicated that dexmedetomidine combined with local anesthetics in nerve block could significantly reduce the postoperative pain score at rest and motion, reduce total opioids consumption and prolong the analgesia duration. Qi Yang et al(16) also found dexmedetomidine administered mostly in vein could reduce the postoperative pain scores with high heterogeneity(I² = 90%). Our results showed the decreased pain scores at different time points postoperatively in Dex. Groups, although some heterogeneity were found. The effect tendency between each studies was concordant that the pain scores in Dex. Groups was decreased compared to Con. Groups in each studies. Great heterogeneity had also been found in other meta-analysis exploring the pain scores without proper interpretation(17, 18). Only a small number of trials were included, which precluded sufficient exploration of heterogeneity through subgroup or meta-regression analysis. We found total opioids consumption were significantly decreased and analgesia duration were prolonged in Dex. Groups which could indirectly reflect the decreased pain intensity postoperatively and no heterogeneity or bias risk were identified. This was consistent with the results in a prospective, randomized, controlled, double-blind, crossover trial conducted in 14 healthy volunteers(19). However, the mechanism underlying this prolonged analgesic effect remained unclear because the elimination half-life period is only 2 hours in tissue. Different pathways between the sedation and analgesic effects of dexmedetomidine could explain it perhaps(16). The effect of dexmedetomidine is mediated by the ascending noradrenergic pathway in the locus coeruleus, while the analgesic effect occurs via an a2- adrenergic receptor-dependent descending pathway in the spinal cord(20). Animal studies have shown that the addition of dexmedetomidine to local anesthetic would increase the duration of sensory and motor blockade in a rat model of sciatic nerve blockade(21).

Motor strength was another important aspect for the patients and their surgeons because early rehabilitation was essential and helpful for the success of TKA. However, nerve block was associated with delayed ambulation(4) and risk for falling(5). Low quality evidence with limited samples in our meta-analysis showed that dexmedetomidine combined with local anesthetics in nerve block could increase the motor strength compared to local anesthetics alone. As we know, ropivacaine was less lipophilic than bupivacaine and less likely to penetrate large myelinated motor fibers(22). Perhaps the added dexmedetomidine could help local anesthetics less penetrate motor fibers. However, larger RCTs and more endeavor should be taken to confirm and explain it.

Median quality evidence showed a better sedation degree when dexmedetomidine combined with local anesthetics in nerve block after TKA. Dexmedetomidine had a good effect on sedation which had been commonly used in anesthesia. So even administered in nerve block, its sedation effect could not be totally eliminated. This could do some help for most of the patients who would feel anxiety for their operation and postoperative pain.

Median quality evidence showed the similar incidence of postoperative nausea and vomiting, and other related complications between the two groups. Nausea and vomiting, hypotension, bradycardia, neuropathy, infection, excessive sedation are the possible complications related to dexmedetomidine or nerve block(23–25), while they were not increased in our meta-analysis, which was consistent with another meta-analysis explored in knee arthroscopy(26). On the contrary, Qi Yang et al(16) in their meta-analysis found that dexmedetomidine treatment could decrease the incidence of postoperative nausea and vomiting, and increase the risk of bradycardia in TKA. Dexmedetomidine in most of studies included in their meta-analysis were administered in vein which would influence the whole body status more greatly. To some extent, it was safe to add dexmedetomidine to nerve block, but more attention should be paid to the dosage of dexmedetomidine especially in elder patients. Median quality evidence showed dexmedetomidine combined with local anesthetics could improve the patient satisfaction. Better analgesia, lower opioid consumption, better ambulation and no increased adverse effects are the possible contributory factors for higher satisfaction.

Our meta-analysis had the following limitations. First, only 7 RCTs were included in our meta-analysis, and the size of every RCT was not so big enough. More and larger-sized RCTs were needed to certify these results. Second, the included RCTs only evaluated the immediate effects within 48 hours after TKA, and longer outcomes were not explored. Therefore, a long-term follow-up study was needed to investigate functional outcomes. Third, only English publications were included in our meta-analysis. Fourth, with regard to the significant heterogeneity of postoperative pain scores, we tried to find the source of heterogeneity without proper interpretation. However, the effect tendency between each studies was concordant.

Compared with local anesthetics alone in nerve block, dexmedetomidine combined with local anesthetics could relief postoperative pain, decrease total opioids consumption, prolong the analgesia duration, improve patient satisfaction without increasing related complications postoperatively. More prospective RCTs with larger size are need to certify the effectiveness and safety. Taken the quality of evidence in this meta-analysis into consideration, we cautiously recommended dexmedetomidine as an adjunct to local anesthetics in nerve block after TKA to clinical practice.

TKA: Total Knee Arthroplasty

VAS: Visual Analogue Scale

NRS: Numerical Rating Scale

PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analyses

RCT: Randomized Controlled Trials

Ethics approval and consent to participate

Not applicable

Consent for publication

Not applicable.

Availability of data and materials

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Funding

No funding

Authors’ contributions

Liping Pan: research design, data collection and analysis, drafting the paper

Hao Wu: data collection and analysis, drafting and revising the paper

Heng Liu: study screening, revising the paper

Xin Yang: study screening, revising the paper

Zhichao Meng: study screening, revising the paper

Yongping Cao: research design, revising the paper, supervision and validation

Acknowledgements

Not applicable.

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Dexmedetomidine as an adjunct to local anesthetics in nerve block relieved pain more effectively after TKA: A meta-analysis of randomized controlled trials

Status:

Journal Publication

Version 1

Abstract

Figures

Background

Methods

Search Strategy

Inclusion Criteria

Data Extraction

Risk of Bias and Quality Assessment

Statistical Analysis

Results

Search Result and Risk Assessment

Study Characteristics

Primary Outcomes

Pain scores

Total opioids consumption in 24 hours postoperatively

Analgesia duration

Patient satisfaction

Secondary Outcomes

Motor strength

Sedation degree

Nausea and vomiting

Total complications

Discussion

Conclusions

List of Abbreviations

Declarations

References

Supplementary Files

Status:

Journal Publication

Version 1