Management Of Pain After Cesarean Trial

Study Overview
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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.

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.

Official Title
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Management Of Pain After Cesarean Trial

Conditions
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Pain, Postoperative, Opioid Use

Intervention / Treatment
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* Drug: Acetaminophen
* Drug: Placebo
* Drug: Ibuprofen


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Ibuprofen and placebo<br>Oral administration of ibuprofen 600 mg tablet and placebo tablet every 6 hours | Drug: Placebo<br>* Placebo oral tablet every 6 hours<br>Drug: Ibuprofen<br>* Ibuprofen 600 mg tablet every 6 hours<br>|
| Active Comparator: Ibuprofen and acetaminophen<br>Oral administration of ibuprofen 600 mg tablet and acetaminophen 650 mg tablet every 6 hours | Drug: Acetaminophen<br>* Acetaminophen 650 mg tablet every 6 hours<br>Drug: Ibuprofen<br>* Ibuprofen 600 mg tablet every 6 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | 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. | second post-operative day (mid-day, 12 PM - 4 PM) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opiate consumption in hospital | Total number of oxycodone 5 mg tablets | Days 1-3 of hospital admission | 
| Opiate consumption week 1 | Total number of oxycodone 5 mg tablets | post-discharge days 1-7 | 
| Opiate consumption week 2 | Total number of oxycodone 5 mg tablets | post-discharge days 8-14 | 
| Pain score post-operative day 1 mid-day | 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. | Day 1 mid-day (12 pm - 4 pm) | 
| Pain score post operative day 1 PM | 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. | Day 1 evening (8 pm - 12 am) | 
| Pain score post operative day 2 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. | Day 2 morning (4 am - 10 am) | 
| Pain score post operative day 2 PM | 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. | Day 2 evening (8 pm - 12 am) | 
| Pain score post operative day 3 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. | Day 3 morning (4 am - 10 am) | 
| WHOQOL-BREF score, domain 1 | 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. | Day 14 | 
| WHOQOL-BREF score, domain 2 | 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. | Day 14 | 
| WHOQOL-BREF score, domain 3 | 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. | Day 14 | 
| WHOQOL-BREF score, domain 4 | 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. | Day 14 |