170: Outpatient opioid use after multimodal pain management for cesarean delivery: A randomized control trial

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.

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Faculty Opinions recommendation of The Effect of Adding Subarachnoid Epinephrine to Hyperbaric Bupivacaine and Morphine for Repeat Cesarean Delivery: A Double-Blind Prospective Randomized Control Trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.732041003.793544337 ◽

2018 ◽

Author(s):

Hans P Sviggum

Keyword(s):

Cesarean Delivery ◽

Randomized Control Trial ◽

Hyperbaric Bupivacaine ◽

Double Blind ◽

Prospective Randomized Control Trial ◽

Randomized Control ◽

Repeat Cesarean Delivery

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Syringe service program-based telemedicine linkage to opioid use disorder treatment: protocol for the STAMINA randomized control trial

BMC Public Health ◽

10.1186/s12889-021-10669-0 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Dennis P. Watson ◽

James A. Swartz ◽

Lisa Robison-Taylor ◽

Mary Ellen Mackesy-Amiti ◽

Kim Erwin ◽

...

Keyword(s):

Study Protocol ◽

Randomized Control Trial ◽

Treatment Protocol ◽

Opioid Use Disorder ◽

Additional Treatment ◽

Initial Assessment ◽

Opioid Use ◽

Structured Interviews ◽

Randomized Control ◽

Opioid Users

Abstract Background A key strategy for mitigating the current opioid epidemic is expanded access to medications for treating opioid use disorder (MOUD). However, interventions developed to expand MOUD access have limited ability to engage opioid users at higher levels of overdose risk, such as those who inject opioids. This paper describes the study protocol for testing STAMINA (Syringe Service Telemedicine Access for Medication-assisted Intervention through NAvigation), an intervention that engages high-risk opioid users at community-based syringe service programs (SSP) and quickly links them to MOUD using a telemedicine platform. Methods This randomized control trial will be conducted at three SSP sites in Chicago. All participants will complete an initial assessment with a provider from a Federally Qualified Health Center who can prescribe or refer MOUD services as appropriate. The control arm will receive standard referral to treatment and the intervention arm will receive immediate telemedicine linkage to the provider and (depending on the type of MOUD prescribed) provided transportation to pick up their induction prescription (for buprenorphine or naltrexone) or attend their intake appointment (for methadone). We aim to recruit a total of 273 participants over two years to provide enough power to detect a difference in our primary outcome of MOUD treatment linkage. Secondary outcomes include treatment engagement, treatment retention, and non-MOUD opioid use. Data will be collected using structured interviews and saliva drug tests delivered at baseline, three months, and six months. Fixed and mixed effects generalized linear regression analyses and survival analysis will be conducted to compare the probabilities of a successful treatment linkage between the two arms, days retained in treatment, and post-baseline opioid and other drug use. Discussion If successful, STAMINA’s telemedicine approach will significantly reduce the amount of time between SSP clients’ initial indication of interest in the medication and treatment initiation. Facilitating this process will likely lead to stronger additional treatment- and recovery-oriented outcomes. This study is also timely given the need for more rigorous testing of telemedicine interventions in light of temporary regulatory changes that have occurred during the COVID-19 pandemic. Trial registration ClinicalTrials.gov (Clinical Trials ID: NCT04575324 and Protocol Number: 1138–0420). Registered 29 September 2020. The study protocol is also registered on the Open Science Framework (DOI 10.17605/OSF.IO/4853 M).

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