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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Management Of Pain After Cesarean Trial

Clinicaltrials.gov identifier NCT03929640

Recruitment Status Recruiting

First Posted April 29, 2019

Last update posted September 18, 2020

Study Description

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.

  • Condition or Disease:Pain, Postoperative
    Opioid Use
  • Intervention/Treatment: Drug: Acetaminophen
    Drug: Placebo
    Drug: Ibuprofen
  • Phase: Phase 3
Detailed Description

The investigators have designed a double-blinded randomized, controlled trial to compare a standardized pain regimen of scheduled ibuprofen and acetaminophen to scheduled ibuprofen and placebo. In both arms, the participant will have the ability to ask for medication for breakthrough pain which will be oxycodone. By standardizing and scheduling the administration of ibuprofen with acetaminophen, the investigators hypothesize that total opioid requested and therefore consumed will be decreased in this participants who receive ibuprofen scheduled with acetaminophen. The investigators will primarily assess pain as reported on a 10-point scale mid-day on the second post-operative day. Secondarily, the investigators will collect reported pain scores and total opiate consumption while in the hospital, opiate consumption after discharge, and quality of life as assessed by the World Health Organization Quality of Life "Bref" (WHOQOL-BREF) survey. This information will be obtained via chart review and at-home surveys administered via email on the Research Electronic Data Capture (REDCap) system one and two weeks after surgery. Enrollment will be performed by study staff. Participants will then be randomized by the institution's Investigational Drug Services (IDS) in REDCap, which uses a randomization table generated by Penn State University (PSU) bio-statisticians. A medication packet will then be prepared and distributed by IDS for the participant containing 20 tablets of acetaminophen 650 mg or placebo based on randomization assignment. The packet will then be sent to nursing staff caring for the patient. Participants will then receive study medication/placebo along with ibuprofen 600 mg (dispensed by the clinical pharmacy) every 6 hours. Participants will be able to request medication for breakthrough pain which will be oxycodone 5 mg or 10 mg depending on reported pain score (one pill for moderate pain, two pills for severe pain). Both ibuprofen and oxycodone will be ordered and dispensed by the clinical pharmacy. Until the participant is deemed able to receive medication by mouth, the participant may receive medication as prescribed by the caring obstetrician and/or anesthesiologist which will be beyond the scope of this trial. Pain scores will be collected and recorded in the medical chart by nursing and assistant staff as part of routine care. At discharge, participants will receive a standard prescription for 20 tablets of oxycodone 5 mg with directions to take 1-2 tablets every 6-8 hours as needed for breakthrough pain, as is the current group standard at the institution in the Department of Obstetrics and Gynecology. After discharge, study staff will then conduct a chart review to collect demographic information, review the operative report, and ensure no event took place which would exclude the participant from the study. Study staff will also record total opiate consumption and pain scores. One week after surgery, the participant will receive an invitation via electronic mail (e-mail) to complete a survey on REDCap which will assess opiate consumption and perceived appropriateness of pain control. Two weeks after surgery, participants will receive two additional invitations; one to complete another survey to assess opiate consumption and perceived appropriateness of pain control, and a second to complete the WHOQOL-BREF. The WHOQOL-BREF survey has been validated to assess four distinct categories of quality of life in women two weeks postpartum. These invitations and reminders have been designed to occur automatically with the assistance of features inherent to the REDCap program. Participants will be considered non-compliant if they fail to complete surveys within three days of receiving their invitation.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 144 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Treatment
  • Official Title: Management Of Pain After Cesarean Trial
  • Actual Study Start Date: August 2019
  • Estimated Primary Completion Date: June 2021
  • Estimated Study Completion Date: July 2021
Arms and interventions
Arm Intervention/treatment
Active Comparator: Ibuprofen and acetaminophen
Oral administration of ibuprofen 600 mg tablet and acetaminophen 650 mg tablet every 6 hours
Drug: Acetaminophen
Acetaminophen 650 mg tablet every 6 hours

Drug: Ibuprofen
Ibuprofen 600 mg tablet every 6 hours
Placebo Comparator: Ibuprofen and placebo
Oral administration of ibuprofen 600 mg tablet and placebo tablet every 6 hours
Drug: Placebo
Placebo oral tablet every 6 hours

Drug: Ibuprofen
Ibuprofen 600 mg tablet every 6 hours
Outcome Measures
  • Primary Outcome Measures: 1. Pain score [ Time Frame: second post-operative day (mid-day, 12 PM - 4 PM) ]
    Pain score on a scale of 0 (no pain) to 10 (worst pain); mid-day 12 PM - 4 PM; "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.
  • Secondary Outcome Measures: 1. Pain score post operative day 2 PM [ Time Frame: Day 2 evening (8 pm - 12 am) ]
    Pain score in the evening (8 pm - 12 am) of post-operative day 2; "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.
  • 2. Opiate consumption in hospital [ Time Frame: Days 1-3 of hospital admission ]
    Total number of oxycodone 5 mg tablets
  • 3. Opiate consumption week 1 [ Time Frame: post-discharge days 1-7 ]
    Total number of oxycodone 5 mg tablets
  • 4. Opiate consumption week 2 [ Time Frame: post-discharge days 8-14 ]
    Total number of oxycodone 5 mg tablets
  • 5. Pain score post-operative day 1 mid-day [ Time Frame: Day 1 mid-day (12 pm - 4 pm) ]
    Pain score mid day (12 pm - 4 pm) on post-operative day 1; "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.
  • 6. Pain score post operative day 1 PM [ Time Frame: Day 1 evening (8 pm - 12 am) ]
    Pain score in the evening (8 pm - 12 am) of post-operative day 1; "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.
  • 7. Pain score post operative day 2 AM [ Time Frame: Day 2 morning (4 am - 10 am) ]
    Pain score in the morning (4 am - 10 am) of post-operative day 2; "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.
  • 8. Pain score post operative day 3 AM [ Time Frame: Day 3 morning (4 am - 10 am) ]
    Pain score in the morning (4 am - 10 am) of post-operative day 3; "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.
  • 9. WHOQOL-BREF score, domain 1 [ Time Frame: Day 14 ]
    Score on World Health Organization Quality of Life - Brief (WHOQOL-BREF) survey two weeks after delivery. The survey evaluates four domains of quality of life including physical health, psychological, social relationships, and environment via 26 questions. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). All questions are presented in specific order as designed by the WHO and assigned to a domain. Domain scores are calculated and converted as integers according to the published manual available here: https://www.who.int/mental_health/media/en/76.pdf.
  • 10. WHOQOL-BREF score, domain 2 [ Time Frame: Day 14 ]
    Score on World Health Organization Quality of Life - Brief (WHOQOL-BREF) survey two weeks after delivery. The survey evaluates four domains of quality of life including physical health, psychological, social relationships, and environment via 26 questions. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). All questions are presented in specific order as designed by the WHO and assigned to a domain. Domain scores are calculated and converted as integers according to the published manual available here: https://www.who.int/mental_health/media/en/76.pdf.
  • 11. WHOQOL-BREF score, domain 3 [ Time Frame: Day 14 ]
    Score on World Health Organization Quality of Life - Brief (WHOQOL-BREF) survey two weeks after delivery. The survey evaluates four domains of quality of life including physical health, psychological, social relationships, and environment via 26 questions. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). All questions are presented in specific order as designed by the WHO and assigned to a domain. Domain scores are calculated and converted as integers according to the published manual available here: https://www.who.int/mental_health/media/en/76.pdf.
  • 12. WHOQOL-BREF score, domain 4 [ Time Frame: Day 14 ]
    Score on World Health Organization Quality of Life - Brief (WHOQOL-BREF) survey two weeks after delivery. The survey evaluates four domains of quality of life including physical health, psychological, social relationships, and environment via 26 questions. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). All questions are presented in specific order as designed by the WHO and assigned to a domain. Domain scores are calculated and converted as integers according to the published manual available here: https://www.who.int/mental_health/media/en/76.pdf.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Pregnant women at least 18 years of age

- Planned delivery via C-section

- Pfannenstiel skin incision

- Lower uterine segment transverse hysterotomy

- English speaking

Exclusion Criteria:

- 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

Contacts and Locations
Contacts

Contact: Avi Hameroff, MD 7175318142 ext 5 ahameroff@pennstatehealth.psu.edu

Contact: Serdar Ural, MD 7175318142 sural@pennstatehealth.psu.edu

Locations

United States, Pennsylvania
Pennsylvania State University Hershey Medical Center
Hershey

Sponsors and Collaborators

Milton S. Hershey Medical Center

More Information