Am J Perinatol 2019; 36(11): 1097-1105 DOI: 10.1055/s-0039-1681096
SMFM Fellowship Series Article
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.
Multimodal Pain Management for Cesarean Delivery: A Double-Blinded, Placebo-Controlled, Randomized Clinical Trial
Emily E. Hadley
1
Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas
,
Luis Monsivais
1
Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas
,
Lucia Pacheco
1
Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas
,
Rovnat Babazade
2
Department of Anesthesia, The University of Texas Medical Branch, Galveston, Texas
,
Giuseppe Chiossi
1
Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas
,
Yara Ramirez
1
Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas
,
Viviana Ellis
1
Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas
,
Michelle Simon
2
Department of Anesthesia, The University of Texas Medical Branch, Galveston, Texas
,
George R. Saade
1
Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas
,
Maged Costantine
1
Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas
› Author AffiliationsFunding This study was supported by funds from the Department of Obstetrics and Gynecology at The University of Texas Medical Branch.
Objective Our objective was to evaluate the efficacy of perioperative multimodal pain management in reducing opioid use after elective cesarean delivery (CD).
Study Design A single-center, double-blinded, placebo-controlled randomized trial of women undergoing elective CD. Participants were allocated 1:1 to receive the multimodal protocol or matching placebos. The multimodal protocol consisted of a preoperative dose of intravenous acetaminophen, preincision injection of subcutaneous bupivacaine, and intraoperative injection of intramuscular ketorolac. Primary outcome was total opioid intake at 48 hours postoperatively. Secondary outcomes were pain scores, time to first opioid intake, neonatal outcomes, and total outpatient opioid intake on postoperative day (POD) 7. Data were analyzed using parametric and nonparametric tests and quantile regression as appropriate.
Results A total of 242 women were screened with 120 randomized, 60 to the multimodal group and 60 to control group. There was no significant difference in the primary outcome of opioid use nor in the secondary outcomes. Smokers and patients with a history of drug use had higher median postoperative opiate use and earlier administration. On POD 7, only 40% of prescribed opioids had been used, and there was no difference between the groups.
Conclusion This perioperative multimodal pain regimen did not reduce opioid use in 48 hours after CD. Patients who smoke or with a history of drug use required more opioids in the postoperative period. Providers significantly overprescribed opioids after CD.
This trial is registered at ClinicalTrials.gov: Trial registry name: Multimodal Pain Management for CD; URL: https://clinicaltrials.gov/ct2/show/NCT02922985; #NCT 02922985. This study was presented in part at the annual meeting for the Society of Maternal-Fetal Medicine in February 2018 in Dallas, TX and at the annual meeting for the Society for Obstetric Anesthesia and Perinatology in May 2018 in Miami, FL.
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