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www.clinicaltrials.gov (NCT02279628); registered 31 October 2014.
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To the Editor,
Cesarean delivery (CD) is associated with intense postoperative pain that may hamper the rehabilitation process. Although numerous previous studies have evaluated the efficacy of continuous wound infusion (CWI) and intrathecal morphine (ITM), their combination for pain management has been seldom described.1,2 We therefore sought to investigate the benefits of adding CWI to ITM for post-CD analgesia.
We conducted a double-blinded single-centre randomized controlled trial approved by the Ethics Committee (CPP Est III) at the University Maternity of Nancy, France. The study was registered at ClinicalTrials.gov (NCT02279628) and EudraCT (EUDRACT 2012-004498-14). Parturients undergoing elective CD were randomized to the following postoperative analgesia groups: CWI with ropivacaine 0.2% and intrathecal saline (CWI group), ITM (100 µg) plus saline CWI (ITM group), or CWI with ropivacaine 0.2% plus ITM (CWI+ITM group). All patients received spinal anaesthesia with hyperbaric bupivacaine 0.5% (10 mg), 2.5 μg sufentanil, and 100 µg (1 mL) morphine or 1 mL normal saline depending on the group, and a multiorificed wound catheter. At wound closure, a bolus of 20 mL of either normal saline or ropivacaine 0.2% was administered through the wound catheter, followed by an infusion at 7 mL·hr-1 for 24 hr. All patients received multimodal analgesia (acetaminophen, ketoprofen, and intravenous patient-controlled analgesia with morphine). The primary outcome was cumulative postoperative morphine consumption at 48 hr. Secondary outcomes were the incidence of adverse effects, postoperative pain scores (visual analogue scale [VAS]), and chronic pain scores at three months (Douleur Neuropathique 4 [DN4] scores). We calculated the sample size partly based on data from research comparing wound infiltration vs placebo.3 Assuming a mean 48 hr morphine consumption in the CWI, ITM, and ITM+CWI groups of 25 mg, 14 mg, and 10 mg, with a standard deviation of 7 mg, respectively, we determined that at least 49 patients per group were needed to detect a difference of 4 mg of morphine with 80% power and a two-sided alpha of 0.05.
Because of a low recruitment rate (due to changes in French recommendations regarding scheduled CD indications), we enrolled 79 patients instead of the 147 initially planned. Baseline patient characteristics are shown in the Table. Median morphine consumption during the first 48 postoperative hours was significantly lower in the ITM group and ITM+CWI group than in the CWI group (Table). There was no difference in morphine consumption between the ITM and CWI+ITM groups. There were no differences in postoperative pain scores at rest or during activity, first ambulation, and side effects, with the exception of a higher incidence of vomiting in the ITM group (Table). Three months after CD, 40%, 57%, and 41% of women in the ITM, CWI, and ITM+CWI groups reported persistent pain, respectively.
Our results are consistent with those reported in two previous studies that reported on opioid consumption with CWI plus ITM after CD.1,2 Morphine requirements in the CWI group were significantly higher than in groups receiving ITM as reported in the literature.4,5
Limitations of our study include the single-centre design and the low sample size, which rendered the study underpowered. Nevertheless, we would consider it unlikely based on the overall similar morphine consumption and VAS scores in the ITM vs ITM+CWI groups that CWI in addition to ITM offers a clinically important advantage for analgesia after Cesarean delivery.
References
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Barney EZ, Pedro CD, Gamez BH, Fuller ME, Dominguez JE, Habib AS. Ropivacaine and ketorolac wound infusion for post-cesarean delivery analgesia: a randomized controlled trial. Obstet Gynecol 2020; 135: 427-35.
Lavand’homme PM, Roelants F, Waterloos H, De Kock MF. Postoperative analgesic effects of continuous wound infiltration with diclofenac after elective cesarean delivery. Anesthesiology 2007; 106: 1220-5.
Adesope O, Ituk U, Habib AS. Local anaesthetic wound infiltration for postcaesarean section analgesia: a systematic review and meta-analysis. Eur J Anaesthesiol 2016; 10: 731-42.
Lalmand M, Wilwerth M, Fils JF, Van der Linden P. Continuous ropivacaine subfascial wound infusion compared with intrathecal morphine for postcesarean analgesia: a prospective, randomized controlled, double-blind study. Anesth Analg 2017; 125: 907-12.
Acknowledgements
The authors would like to thank Pr Nathalie Thilly for her help with statistical analyses and for critically reviewing the manuscript.
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This work was supported by department funds solely.
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This submission was handled by Dr. Ronald B. George, Associate Editor, Canadian Journal of Anesthesia/Journal canadien d’anesthésie.
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Viviand, C., Pietretti, E., Luc, A. et al. Continuous wound infusion combined with intrathecal morphine for analgesia after Cesarean delivery compared with intrathecal morphine or continuous wound infusion alone. Can J Anesth/J Can Anesth 69, 788–789 (2022). https://doi.org/10.1007/s12630-022-02223-2
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DOI: https://doi.org/10.1007/s12630-022-02223-2