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

NCT05360433 | Unknown Phase 4 FDA Drug

• 1 other identifier: 19-516
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cesarean section; opioid prescription; narcotics; opioids; post operative pain

Outcome Measures

Primary Outcomes (2)

• Total opioid consumption by participants post-cesarean delivery

  Number of tablets of oxycodone consumed for postoperative pain management. This will be measured by a pill count at the participant's 2 week post-op visit and the participant's responses to postoperative surveys at 2 weeks and 6 weeks post surgery.

  2 weeks

• Total opioid consumption by participants post-cesarean delivery

  Number of tablets of oxycodone consumed for postoperative pain management. This will be measured by a pill count at the participant's 2 week post-op visit and the participant's responses to postoperative surveys at 2 weeks and 6 weeks post surgery.

  6 weeks

Secondary Outcomes (6)

• Participant pain rating

  2 weeks

• Participant pain rating

  6 weeks

• Participant satisfaction with pain management

  2 weeks

• Participant satisfaction with pain management

  6 weeks

• Requests for opioid prescription refills by participants

  2 weeks

Study Arms (2)

10 tablet prescription group

ACTIVE COMPARATOR

These participants receive 10 tablets of oxycodone 5 mg at discharge for postoperative pain.

Drug: Oxycodone oral capsule

20 tablet prescription group

ACTIVE COMPARATOR

These participants receive 20 tablets of oxycodone 5 mg at discharge for postoperative pain.

Drug: Oxycodone oral capsule

Interventions

Oxycodone oral capsule DRUG

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

Also known as: opioid prescription size

10 tablet prescription group; 20 tablet prescription group

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• Age 19-40 years old
• Pregnant
• Scheduled to undergo cesarean section at Carilion Roanoke Memorial Hospital
• opioid naïve (defined as no opioid use within 30 days of surgery

You may not qualify if:

• History of chronic pain
• History of opioid use disorder
• History of any known intolerance or allergies to analgesics
• Women with postoperative complications (hysterectomy during or after birth, bowel or bladder injury during birth, need for re-operation, or immediate wound complication)
• Language barrier preventing screening or consent

Sponsors & Collaborators

• Carilion Clinic: lead
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Jaclyn D Nunziato, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robyn N Goodrich, BA

CONTACT

434-825-7630; rgoodrich@vt.edu

Jaclyn D Nunziato, MD

CONTACT

540-655-0459; jdnunziato@carilionclinic.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: May 4, 2022
• Study Start: November 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)