Management Of Pain After Cesarean Trial

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-05

Study Completion Date

2020-03-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain, Postoperative Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ibuprofen and placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo oral tablet every 6 hours

Ibuprofen

Intervention Type DRUG

Ibuprofen 600 mg tablet every 6 hours

Ibuprofen and acetaminophen

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

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

Acetaminophen 650 mg tablet every 6 hours

Ibuprofen

Intervention Type DRUG

Ibuprofen 600 mg tablet every 6 hours

Interventions

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Acetaminophen

Acetaminophen 650 mg tablet every 6 hours

Intervention Type DRUG

Placebo

Placebo oral tablet every 6 hours

Intervention Type DRUG

Ibuprofen

Ibuprofen 600 mg tablet every 6 hours

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No