Management Of Pain After Cesarean Trial

NCT03929640 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 00010393
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double blinded randomized controlled trial to test the efficacy of a combination of acetaminophen and ibuprofen administered to patients on schedule compared to ibuprofen alone on the patient's reported pain score on the second post-operative day after Cesarean delivery. The investigators will also record opiate consumption and pain scores throughout the hospitalization of participants, and will survey patients at one and two weeks after surgery regarding opiate consumption and quality of life.

Conditions

Pain, Postoperative; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Pain Score

  Pain score on a scale of 0 (no pain) to 10 (worst pain); "pain score" is a verbal report of participant pain on a scale of 0-10, 0 indicating no pain and incrementally increasing as integer to a maximum score of 10 indicating the most severe pain possible.

  Post-operative day 2, corresponding to 2 days after cesarean section surgery (day of surgery is considered post-operative day 0). Measurement taken mid-day (12 PM - 4 PM)

Secondary Outcomes (5)

• Opiate Consumption in Hospital

  Post-operative day 0 (day of surgery) until discharged from hospital on post-operative day 3 or 4.

• WHOQOL-BREF Score, Domain 1

  Post-operative Day 14 (two weeks after cesarean section surgery)

• WHOQOL-BREF Score, Domain 2

  Post-operative Day 14 (two weeks after cesarean section surgery)

• WHOQOL-BREF Score, Domain 3

  Post-operative Day 14 (two weeks after cesarean section surgery)

• WHOQOL-BREF Score, Domain 4

  Post-operative Day 14 (two weeks after cesarean section surgery)

Study Arms (2)

Ibuprofen and placebo

PLACEBO COMPARATOR

Oral administration of ibuprofen 600 mg tablet and placebo tablet every 6 hours

Drug: Placebo; Drug: Ibuprofen

Ibuprofen and acetaminophen

ACTIVE COMPARATOR

Oral administration of ibuprofen 600 mg tablet and acetaminophen 650 mg tablet every 6 hours

Drug: Acetaminophen; Drug: Ibuprofen

Interventions

Acetaminophen DRUG

Acetaminophen 650 mg tablet every 6 hours

Ibuprofen and acetaminophen

Placebo DRUG

Placebo oral tablet every 6 hours

Ibuprofen and placebo

Ibuprofen DRUG

Ibuprofen 600 mg tablet every 6 hours

Ibuprofen and acetaminophen; Ibuprofen and placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only women may participate due to pregnancy-related condition being studied
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women at least 18 years of age
• Planned delivery via C-section
• Pfannenstiel skin incision
• Lower uterine segment transverse hysterotomy
• English speaking

You may not qualify if:

• Major intra-operative or post-operative complication such that clinician recommends patient should not receive non-steroidal anti-inflammatory drugs or that patient requires acetaminophen to treat fever (ie suspected endometritis)
• Unplanned surgery (hysterectomy, bowel/bladder repair)
• Allergy or contraindication to study medication
• Non-English speaking
• Inability to provide informed consent
• History of opioid, other illicit substance, or alcohol use disorder either before or during pregnancy
• Severe renal or hepatic impairment

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Pennsylvania State University Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (8)

• Bateman BT, Cole NM, Maeda A, Burns SM, Houle TT, Huybrechts KF, Clancy CR, Hopp SB, Ecker JL, Ende H, Grewe K, Raposo Corradini B, Schoenfeld RE, Sankar K, Day LJ, Harris L, Booth JL, Flood P, Bauer ME, Tsen LC, Landau R, Leffert LR. Patterns of Opioid Prescription and Use After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):29-35. doi: 10.1097/AOG.0000000000002093.

  PMID: 28594763 BACKGROUND

• Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.

  PMID: 26824844 BACKGROUND

• Osmundson SS, Schornack LA, Grasch JL, Zuckerwise LC, Young JL, Richardson MG. Postdischarge Opioid Use After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):36-41. doi: 10.1097/AOG.0000000000002095.

  PMID: 28594766 BACKGROUND

• Prabhu M, McQuaid-Hanson E, Hopp S, Burns SM, Leffert LR, Landau R, Lauffenburger JC, Choudhry NK, Kaimal A, Bateman BT. A Shared Decision-Making Intervention to Guide Opioid Prescribing After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):42-46. doi: 10.1097/AOG.0000000000002094.

  PMID: 28594762 BACKGROUND

• Viteri OA, England JA, Alrais MA, Lash KA, Villegas MI, Ashimi Balogun OA, Chauhan SP, Sibai BM. Association of Nonsteroidal Antiinflammatory Drugs and Postpartum Hypertension in Women With Preeclampsia With Severe Features. Obstet Gynecol. 2017 Oct;130(4):830-835. doi: 10.1097/AOG.0000000000002247.

  PMID: 28885417 BACKGROUND

• Chang AK, Bijur PE, Esses D, Barnaby DP, Baer J. Effect of a Single Dose of Oral Opioid and Nonopioid Analgesics on Acute Extremity Pain in the Emergency Department: A Randomized Clinical Trial. JAMA. 2017 Nov 7;318(17):1661-1667. doi: 10.1001/jama.2017.16190.

  PMID: 29114833 BACKGROUND

• Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with nonsteroidal antiinflammatory drugs: a qualitative systematic review of analgesic efficacy for acute postoperative pain. Anesth Analg. 2010 Apr 1;110(4):1170-9. doi: 10.1213/ANE.0b013e3181cf9281. Epub 2010 Feb 8.

  PMID: 20142348 BACKGROUND

• Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.

  PMID: 15085902 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Enrollment was suspended when the co-investigator responsible for study recruitment left the institution in 2020. At that time, only 49 subjects had been randomized (study enrollment goal was 150 subjects). The PI kept the study open but was not successful in finding a replacement to lead the study so it was eventually terminated.

Results Point of Contact

• Title: Serdar Ural
• Organization: Milton S. Hershey Medical Center

sural@pennstatehealth.psu.edu

717-531-6209

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 29, 2019
• Study Start: August 5, 2019
• Primary Completion: March 14, 2020
• Study Completion: March 26, 2020
• Last Updated: September 4, 2024
• Results First Posted: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)