Impact of the Number of Opiates Prescribed on Post Cesarean Pain Control

Assessing the Impact of the Number of Opiates Prescribed on Post Cesarean Pain Control: A Randomized Controlled Trial

The purpose of this randomized trial is to examine whether the number of opioid pills prescribed for pain control after Cesarean section has an effect on patient reported pain levels and satisfaction with pain control during recovery. Both groups receive what is considered an adequate number of pills for pain control after an uncomplicated Cesarean delivery. Secondarily, the investigators wish to gather reliable information about the duration of use of opioids for pain control after uncomplicated Cesarean section, and what happens to unused medication.

After an uncomplicated Cesarean section, patients will be approached and asked to participate in the study. If the patient agrees, she will be randomly assigned to one of the two study groups and receive a prescription for opioid medication at the time of hospital discharge. At her standard care follow-up visit 10-14 days later, the participant will complete a survey asking questions about her pain levels during recovery, her use of study-related and non-study-related pain medication, and satisfaction with pain control. At that point the patient's participation in the study will end.

Study Overview

• Status: Withdrawn
• Conditions: Post-operative Pain Control
• Intervention / Treatment: Other: Oxycodone Pill A; Other: Oxycodone Pill B

Detailed Description

Study Design and Methods:

The investigators will conduct a randomized controlled trial evaluating the difference in postpartum pain control in women receiving two different amounts of oxycodone after cesarean delivery.

Primary outcomes

• The primary outcome is the percent of patients who refill their narcotic prescription after cesarean delivery.

Secondary outcomes

1. Duration of use of narcotic after cesarean delivery, as assessed by the Post Cesarean Pain Control Survey (see attachment).
2. Amount of narcotic unused after cesarean delivery, measured in number of remaining pills, as assessed by the Post Cesarean Pain Control Survey.
3. Disposition of unused drug, as assessed by the Post Cesarean Pain Control Survey.
4. Patient satisfaction with pain control after cesarean delivery, as assessed by the Post Cesarean Pain Control Survey.

Patients will be identified by one of the investigators or designated research staff as either scheduled to undergo repeat cesarean delivery or status post cesarean from review of postpartum delivery lists. If they meet inclusion and exclusion criteria, they will be approached for enrollment in the study. If they consent they will be randomized on the day of discharge to group A or group B via sequentially numbered, sealed, opaque envelope. All patients will be provided standard education regarding pain control in the form of a fact sheet regarding trajectories of pain resolution, normative opioid consumption post cesarean, as well as risks, benefits and alternatives to opiates. If unable to purchase over the counter medications, prescriptions for ibuprofen and acetaminophen will be provided, as well as phone numbers for contact should any concerns arise between the time of discharge and post operative assessment. The patient will be scheduled for a postoperative wound check 10-14 days postpartum.

Postoperative wound evaluation will be performed in the research site's OB clinic setting at which time the survey will be completed by the patient regarding satisfaction with pain control, length of opiate treatment, number of opiates left in prescription and need for refills.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43222
      • Mt Carmel Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women 18-45 years
• English, Somali or Spanish Speaking
• Status post uncomplicated cesarean delivery performed at term (37w 0d to 42w 0d at time of delivery)
• Discharged at day 3 or 4 after cesarean section
• Willingness to participate in a survey 10-14 days post cesarean

Exclusion Criteria:

• History of or current narcotic abuse
• History of chronic pain
• History or current opiate addiction
• Complicated cesarean delivery including cesarean hysterectomy, EBL >1500 cc, bowel or bladder injury, postpartum infectious morbidity, postpartum wound break down
• Neonatal outcome requiring NICU admission for more than 48 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A - Oxycodone Pill A; Participants in this study arm will receive a prescription for a lower number oxycodone (oxycodone A) pills for post-cesarean pain control.	Other: Oxycodone Pill A; Prescription for oxycodone pills for post-Cesarean delivery pain control after hospital discharge. Oxycodone is an opioid.; Other Names: Oxycodone pill - lower number
Active Comparator: Arm B - Oxycodone Pill B; Participants in this study arm will receive a prescription for a higher number of oxycodone (oxycodone B) pills for post-cesarean pain control.	Other: Oxycodone Pill B; Prescription for oxycodone pills for post-Cesarean delivery pain control after hospital discharge. Oxycodone is an opioid.; Other Names: Oxycodone pill - higher number

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome is the percent of patients who refill their narcotic prescription after cesarean delivery. .	This outcome will be assessed by survey and confirmed with Ohio Automatic Rx Reporting System (OARRS) review performed on the same day as survey completion	7-14 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of use of narcotic after cesarean	As assessed by the Post Cesarean Pain Control Survey	7-14 days after surgery
Amount of narcotic unused after cesarean delivery.	Measured in number of remaining pills, as assessed by the Post Cesarean Pain Control Survey	7-14 days after surgery
Disposition of unused drug	As assessed by the Post Cesarean Pain Control Survey.	7-14 days after surgery
Patient satisfaction with pain control after cesarean delivery	As assessed by the Post Cesarean Pain Control Survey.	7-14 days after surgery

Collaborators and Investigators

• Sponsor: Mount Carmel Health System
• Investigators: Principal Investigator: Mona Prasad, DO, Mount Carmel Health System

Publications and helpful links

General Publications

• Osmundson SS, Schornack LA, Grasch JL, Zuckerwise LC, Young JL, Richardson MG. Postdischarge Opioid Use After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):36-41. doi: 10.1097/AOG.0000000000002095.
• Reddy UM. Screening, Prevention, and Treatment of Opioid Use Disorder During Pregnancy: Expectant Mothers Are Depending on You! Obstet Gynecol. 2016 Jul;128(1):1-3. doi: 10.1097/AOG.0000000000001505. No abstract available.
• Krans EE, Patrick SW. Opioid Use Disorder in Pregnancy: Health Policy and Practice in the Midst of an Epidemic. Obstet Gynecol. 2016 Jul;128(1):4-10. doi: 10.1097/AOG.0000000000001446.
• Pfuntner A, Wier LM, Stocks C. Most Frequent Procedures Performed in U.S. Hospitals, 2011. 2013 Oct. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #165. Available from http://www.ncbi.nlm.nih.gov/books/NBK174682/

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2017
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Oxycodone
• Other Study ID Numbers: 170214-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No