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      Bilateral single-injection erector spinae plane block versus intrathecal morphine for postoperative analgesia in living donor laparoscopic hepatectomy: a randomized non-inferiority trial

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          Abstract

          Background

          Intrathecal morphine (ITM) provides effective postoperative analgesia in living donor hepatectomy but has significant adverse effects. Studies support the efficacy of erector spinae plane (ESP) blocks in laparoscopic abdominal surgery; we therefore hypothesized that they would provide non-inferior postoperative analgesia compared with ITM and reduce postoperative nausea/vomiting and pruritus. We conducted a randomized, controlled, non-inferiority trial to compare the analgesic efficacy of ITM and bilateral single-injection ESP blocks in laparoscopic donor hepatectomy.

          Methods

          Fifty-four donors were randomized to receive bilateral ESP blocks with 20 mL 0.5% ropivacaine (n=27) or 400 µg ITM (n=27). Primary outcome was resting pain score 24 hours postoperatively measured on an 11-point numeric rating scale. The prespecified non-inferiority limit was 1. Incidences of postoperative nausea/vomiting and pruritus were assessed.

          Results

          The mean treatment difference (ESP–ITM) in the primary outcome was 1.2 (95% CI 0.7 to 1.8). The 95% CI upper limit exceeded the non-inferiority limit. Opioid consumption and all other pain measurements were similar between groups up to 72 hours postoperatively. The ESP group had significantly lower incidences of postoperative vomiting (p=0.002) and pruritus (p<0.001).

          Conclusions

          Bilateral single-injection ESP blocks resulted in higher resting pain scores 24 hours postoperatively compared with ITM and thus did not meet the study definition of non-inferiority. However, the pain intensity with ESP blocks was mild (mean pain scores <3/10) and associated with reduced incidence of postoperative vomiting and pruritus. It warrants further investigation as an analgesic option after laparoscopic living donor hepatectomy.

          Trial registration number

          KCT0003191.

          Related collections

          Most cited references30

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          A Cadaveric Study Investigating the Mechanism of Action of Erector Spinae Blockade

          Erector spinae block is an ultrasound-guided interfascial plane block first described in 2016. The objectives of this cadaveric dye injection and dissection study were to simulate an erector spinae block to determine if dye would spread anteriorly to the involve origins of the ventral and dorsal branches of the spinal nerves.
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            Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement.

            The CONSORT (Consolidated Standards of Reporting Trials) Statement, including a checklist and a flow diagram, was developed to help authors improve their reporting of randomized controlled trials. Its primary focus was on individually randomized trials with 2 parallel groups that assess the possible superiority of one treatment compared with another but is now being extended to other trial designs. Noninferiority and equivalence trials have methodological features that differ from superiority trials and present particular difficulties in design, conduct, analysis, and interpretation. Although the rationale for such trials occurs frequently, those designed and described specifically as noninferiority or equivalence trials appear less commonly in the medical literature. The quality of reporting of those that are published is often inadequate. In this article, we present an adapted CONSORT checklist for reporting noninferiority and equivalence trials and provide illustrative examples and explanations for those items amended from the original CONSORT checklist. The intent is to improve reporting of noninferiority and equivalence trials, enabling readers to assess the validity of their results and conclusions.
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              The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair.

              Laparoscopic ventral hernia repair is an operation associated with significant postoperative pain, and regional anaesthetic techniques are of potential benefit. The erector spinae plane (ESP) block performed at the level of the T5 transverse process has recently been described for thoracic surgery, and we hypothesised that performing the ESP block at a lower vertebral level would provide effective abdominal analgesia. We performed pre-operative bilateral ESP blocks with 20-30 ml ropivacaine 0.5% at the level of the T7 transverse process in four patients undergoing laparoscopic ventral hernia repair. Median (range) 24-h opioid consumption was 18.7 mg (0.0-43.0 mg) oral morphine. The highest and lowest median (range) pain scores in the first 24 h were 3.5 (3.0-5.0) and 2.5 (0.0-3.0) on an 11-point numerical rating scale. We also performed the block in a fresh cadaver and assessed the extent of injectate spread using computerised tomography. There was radiographic evidence of spread extending cranially to the upper thoracic levels and caudally as far as the L2-L3 transverse processes. We conclude that the ESP block is a promising regional anaesthetic technique for laparoscopic ventral hernia repair and other abdominal surgery when performed at the level of the T7 transverse process. Its advantages are the ability to block both supra-umbilical and infra-umbilical dermatomes with a single-level injection and its relative simplicity.
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                Author and article information

                Contributors
                Journal
                Regional Anesthesia & Pain Medicine
                Reg Anesth Pain Med
                BMJ
                1098-7339
                1532-8651
                October 23 2019
                : rapm-2019-100902
                Article
                10.1136/rapm-2019-100902
                9fcea58b-2ad4-4c83-8f09-aee326050b37
                © 2019
                History

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