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Completed

NCT Number: NCT04296396

Opioid Prescription After Cesarean Trial

Non-inferiority randomized trial of 5,500 women with a cesarean delivery randomized prior to discharge to either an individualized opioid prescription protocol (IOPP) that includes shared decision making or to a fixed opioid prescription of 20 tablets of oxycodone 5mg.

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Key information

Conditions

Pregnancy Related Neurologic Manifestations Opioid Use Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama - Birmingham, Birmingham, Alabama, United States

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About this study

This was a non-inferiority multi-center unblinded randomized trial of 5,500 women undergoing a cesarean delivery who were randomized before discharge to either an individualized opioid prescription protocol (IOPP) that includes shared decision making or to a fixed opioid prescription of 20 tablets of oxycodone 5mg. The primary endpoint was the presence/absence of moderate to severe pain at 1 week after discharge. Moderate to severe pain was defined as a value of 4 or higher on the Brief Pain Inventory worst pain scale (0 to 10) in the last 24 hours. Consenting women were assigned in a 1:1 ratio to one of the two arms using a secure internet based randomization system maintained centrally by the Data Coordinating Center (DCC). Randomization was stratified by site. Women were followed through 90 days postpartum.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Post cesarean delivery (combined vaginal/cesarean deliveries are not eligible)
  • Singleton, twin or triplet gestation

Exclusion criteria

  • An opioid prescription filled during the current pregnancy
  • Known history of opioid use disorder, by medical record review
  • Contraindication to opioids (oxycodone)
  • Contraindications to both acetaminophen and ibuprofen
  • Significant surgical procedures (e.g., hysterectomy) prior to randomization as pain trajectory will be completely different
  • Fetal or neonatal death prior to randomization
  • Inability to randomize within 1 day before planned discharge from the hospital
  • Inability to participate in shared decision making as assessed by research staff
  • Language barrier (non-English or Spanish speaking)
  • Participation in this trial in a previous pregnancy
  • Participation in another intervention study that influences the primary outcome in this trial

Treatment and study plan

0 to 20 tablets of oxycodone 5mg

Drug

Individualized opioid prescription protocol (IOPP) that includes shared decision making

Fixed opioid prescription

Drug

20 tablets of oxycodone 5mg

Primary outcomes

  1. Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory

    Time frame: 1 week post hospital discharge

    Number of participants with moderate to severe pain at 1 week post-discharge; moderate to severe pain is defined as a value of 4 or higher on the "Worst Pain" question of the Brief Pain Inventory (BPI) in the last 24 hours. The BPI measures pain severity on a numeric scale of 0 to 10, with 0 being no pain and 10 being the highest level of pain.

Secondary outcomes

  1. Number of Participants Who Filled One or More Opioid Prescriptions Beyond the Amount Prescribed at Discharge

    Time frame: After hospital discharge and up to 90 days postpartum

    Number of participants who filled one or more opioid prescriptions beyond what was prescribed to them at discharge - measured at ninety days postpartum

  2. Number of Opioid Prescriptions Filled

    Time frame: 90 days postpartum

    Number of opioid prescriptions filled by ninety days postpartum

  3. Number of Opioid Tablets Unused Since Discharge

    Time frame: 90 days postpartum

    Number of opioid tablets unused from discharge to 90 days postpartum

  4. Number of Morphine Milligram Equivalents Used at 2 Weeks Post Discharge

    Time frame: 2 weeks post discharge

    Total morphine milligram equivalents (MME) used from discharge to 2 weeks post-discharge. MME is the amount of milligrams of morphine an opioid dose is equal to when prescribed. Calculating MME accounts for differences in opioid drug type and strength.

  5. Worst Pain Severity Score at 2 Weeks Post Discharge

    Time frame: 2 weeks post discharge

    Pain severity scores assessed on the Brief Pain Inventory numeric scale from 0 to 10 at 2 weeks post-discharge. The BPI measures pain severity on a numeric scale of 0 to 10, with 0 being no pain and 10 being the highest level of pain.

  6. Pain Interference Score ≥ 4 at 2 Weeks Post Discharge

    Time frame: 2 weeks post discharge

    Pain interference scores ≥ 4 on the Brief Pain Inventory (numeric scale from 0 to 10) at 2 weeks post-discharge. The BPI measures pain severity on a numeric scale of 0 to 10, with 0 being no pain and 10 being the highest level of pain. This outcome asks participants to indicate their pain scores for the week prior to completing the inventory.

  7. Number of Participants Who Indicated an Improved Global Impression of Change

    Time frame: 2 weeks post discharge

    Number of participants who indicated an improved global impression of change in overall pain at 2 weeks post-discharge. This represents a selection on a multiple choice survey question with the response options: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.

  8. Infant Hospital Readmissions

    Time frame: 6 weeks postpartum

    Proportion of infants readmitted to the hospital

  9. Maternal Depression Score ≥ 13

    Time frame: 6 weeks postpartum

    The proportion of participants with a score of 13 or higher on the Edinburgh Postnatal Depression Scale. The minimum score is 0 and the maximum score is 30. Higher scores indicate worse outcomes, where persons scoring about 13 are likely to be suffering from a depressive illness. The scale indicates how the respondent has felt during the previous week.

Sponsors and collaborators

Lead sponsor

The George Washington University Biostatistics Center

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Prescription After Cesarean Trial

Acronym: PACT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 5, 2020
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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