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Too Much of a Good Thing? Impact of Initial Prescription Size in Post-cesarean Section Pain Management

NCT05360433 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2022-05-04

No results posted yet for this study

Summary

This is a randomized controlled trial involving 170 opioid naive women ages 19-40 undergoing scheduled C-sections at Carilion Roanoke Memorial Hospital. Participants are randomized to receive either 10 or 20 tabs of oxycodone 5mg as an initial postoperative prescription in a double-blinded parallel trial design. Outcome metrics related to overall opioid consumption and patient satisfaction with pain management are collected at three different time points post-operative: 2-3 days (in hospital), 10-14 days, and 6 weeks.

Conditions

  • Post Operative Pain

Interventions

DRUG

Oxycodone oral capsule

Reduced initial prescription of oxycodone for postoperative pain management following cesarean section.

Sponsors & Collaborators

  • Virginia Polytechnic Institute and State University

    collaborator OTHER

  • Carilion Clinic

    lead OTHER

Principal Investigators

  • Jaclyn D Nunziato, MD · Carilion Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-12-01
Completion
2022-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05360433 on ClinicalTrials.gov