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Management Of Pain After Cesarean Trial (MOPAC)

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ClinicalTrials.gov Identifier: NCT03929640
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Serdar Ural, Milton S. Hershey Medical Center

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 Intervention/treatment Phase
Pain, Postoperative Opioid Use Drug: Acetaminophen Drug: Placebo Drug: Ibuprofen 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.


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Study Type : Interventional  (Clinical Trial)
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 5, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : June 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




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. Opiate consumption in hospital [ Time Frame: Days 1-3 of hospital admission ]
    Total number of oxycodone 5 mg tablets

  2. Opiate consumption week 1 [ Time Frame: post-discharge days 1-7 ]
    Total number of oxycodone 5 mg tablets

  3. Opiate consumption week 2 [ Time Frame: post-discharge days 8-14 ]
    Total number of oxycodone 5 mg tablets

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only women may participate due to pregnancy-related condition being studied
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929640


Contacts
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Contact: Avi Hameroff, MD 7175318142 ext 5 ahameroff@pennstatehealth.psu.edu
Contact: Serdar Ural, MD 7175318142 sural@pennstatehealth.psu.edu

Locations
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United States, Pennsylvania
Pennsylvania State University Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Avi Hameroff, MD    717-531-8142 ext 5    ahameroff@pennstatehealth.psu.edu   
Contact: Serdar Ural, MD    7175318142 ext 5    sural@pennstatehealth.psu.edu   
Sponsors and Collaborators
Milton S. Hershey Medical Center

Publications:

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Responsible Party: Serdar Ural, Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03929640     History of Changes
Other Study ID Numbers: 00010393
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: May collaborate with PSU Addiction Center to perform secondary analyses on data collected, including total opiate consumption and pain scores.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action