Opioid Prescription After Cesarean Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prescription After Cesarean Trial

Conditions
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Pregnancy Related, Opioid Use, Pain

Intervention / Treatment
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* Drug: 0 to 20 tablets of oxycodone 5mg
* Drug: Fixed opioid prescription


Participation Criteria
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Eligibility Criteria
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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
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
Interventional Model Description: Participants were randomized 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individualized Opioid Prescription<br>Individualized opioid prescription protocol and shared decision making | Drug: 0 to 20 tablets of oxycodone 5mg<br>* Individualized opioid prescription protocol (IOPP) that includes shared decision making<br>|
| Other: Fixed Opioid Prescription<br>Fixed opioid prescription of 20 tablets of oxycodone 5mg | Drug: Fixed opioid prescription<br>* 20 tablets of oxycodone 5mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory | 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. | 1 week post hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Filled One or More Opioid Prescriptions Beyond the Amount Prescribed at Discharge | Number of participants who filled one or more opioid prescriptions beyond what was prescribed to them at discharge - measured at ninety days postpartum | After hospital discharge and up to 90 days postpartum | 
| Number of Opioid Prescriptions Filled | Number of opioid prescriptions filled by ninety days postpartum | 90 days postpartum | 
| Number of Opioid Tablets Unused Since Discharge | Number of opioid tablets unused from discharge to 90 days postpartum | 90 days postpartum | 
| Number of Morphine Milligram Equivalents Used at 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. | 2 weeks post discharge | 
| Worst Pain Severity Score at 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. | 2 weeks post discharge | 
| Pain Interference Score ≥ 4 at 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. | 2 weeks post discharge | 
| Number of Participants Who Indicated an Improved Global Impression of Change | 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. | 2 weeks post discharge | 
| Infant Hospital Readmissions | Proportion of infants readmitted to the hospital | 6 weeks postpartum | 
| Maternal Depression Score ≥ 13 | 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. | 6 weeks postpartum |