Towards Enhanced Recovery After Cesarean

NCT04612920 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 12675
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

One in 300 women will become persistent opioid users after cesarean delivery (1). Cesarean delivery is the most common surgical procedure in the United States, representing 31.9% of the 3,788,235 deliveries in 2018 (2). Patients have to cope with the pain and challenges of post-operative care while adjusting to motherhood and completing activities of daily living. Often when they return home, they are also tasked with other domestic roles which compounds the challenge of this post-operative period. With a potential impact just in the US on 1.2 million mothers each year, optimizing post-operative pain management in order to reduce the risk of persistent opioid use represents an urgent unmet public health goal. To this end, there are national efforts to reduce the cesarean rate and optimize post-cesarean pain management (3,4). The majority of efforts in the last few years have focused on home-going medications and alterations in prescription practices. Recent recommendations from the Enhanced Recovery After Surgery Society indicate that patients should receive multi-modal analgesia on a regular basis, along with early post-delivery mobilization (3). However, the efficacy of scheduled non-steroidal anti-inflammatory medications (NSAID) along with acetaminophen in the immediate post-operative period and after going home have not been systematically studied in the cesarean population. We hypothesize that patients who receive scheduled medications in the post-operative period are less likely to require opioids for pain relief both in the hospital and after they return home.

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (2)

• Amount of morphine milligram equivalents used from 25-72 hours post-op

  Patient's inpatient chart will be reviewed to calculate the amount of oxycodone the patient used, converted to morphine milligram equivalents and recorded.

  25-72 hours post-op

• Patient's morphine milligram equivalent usage from day of discharge to outpatient post-operative visit

  The patient will be discharged home with 20 tablets of oxycodone 5mg. When they return to their post-operative visit, we will count the number of tablets left in the pill bottle. A low number of remaining tablets would mean increased medication usage outpatient.

  post-discharge day #8-12

Secondary Outcomes (15)

• Patient's pain rating on post-operative day #2 and #3 with and without ambulation

  post-op days #2 and #3

• Patient's pain satisfaction scale on day of post-operative visit

  1 day of post-operative visit

• Patient's pain satisfaction scale on day of discharge

  1 day of discharge

• Amount of acetaminophen used on post-operative day #2 and #3

  post-operative day #2 and #3

• Amount of ibuprofen used on post-operative day #2 and #3

  post-operative days #2 and #3

Study Arms (2)

Study Group

EXPERIMENTAL

Participants will receive ibuprofen 800mg every eight hours and acetaminophen 1000mg every eight hours, given at the same time, along with oxycodone five mg every six hours PRN for breakthrough pain.

Drug: Ibuprofen, acetaminophen, oxycodone

Standard Group

NO INTERVENTION

Participants will receive current OU standard of care therapy which includes ibuprofen 800mg every eight hours as needed (PRN), acetaminophen 1000mg every eight hours PRN, and oxycodone five mg every six hours PRN.

Interventions

Ibuprofen, acetaminophen, oxycodone DRUG

The timing of medications is the intervention.

Study Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Only females undergoing cesarean section are eligible.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Undergoing repeat cesarean delivery
• ≥37 week gestation
• attended at least 7 prenatal visits
• age ≥18.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University ofOklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Interventions

Ibuprofen; Acetaminophen; Oxycodone

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; 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

• Pavan Parikh, MD

  University of Oklahoma HSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: November 3, 2020
• Study Start: December 12, 2020
• Primary Completion: March 8, 2023
• Study Completion: March 8, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)