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

NCT03175653 | Withdrawn

• 1 other identifier: 170214-2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-operative Pain Control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Duration of use of narcotic after cesarean

  7-14 days after surgery

• Amount of narcotic unused after cesarean delivery.

  7-14 days after surgery

• Disposition of unused drug

  7-14 days after surgery

• Patient satisfaction with pain control after cesarean delivery

  7-14 days after surgery

Study Arms (2)

Arm A - Oxycodone Pill A

EXPERIMENTAL

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

Arm B - Oxycodone Pill B

ACTIVE COMPARATOR

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

Interventions

Oxycodone Pill A OTHER

Prescription for oxycodone pills for post-Cesarean delivery pain control after hospital discharge. Oxycodone is an opioid.

Also known as: Oxycodone pill - lower number

Arm A - Oxycodone Pill A

Oxycodone Pill B OTHER

Prescription for oxycodone pills for post-Cesarean delivery pain control after hospital discharge. Oxycodone is an opioid.

Also known as: Oxycodone pill - higher number

Arm B - Oxycodone Pill B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Females who self-identify, are able to get pregnant and who undergo Cesarean section.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Carmel Health System: lead

Study Sites (1)

Mt Carmel Medical Center

Columbus, Ohio, 43222, United States

Location

Related Publications (4)

• 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.

  PMID: 27275810 BACKGROUND

• 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.

  PMID: 27275812 BACKGROUND

• 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/

  PMID: 24354027 BACKGROUND

• 1. Osmundson, S, Grasch JL, Schornack LA, et al. Opioid Use after cesarean delivery following hospital discharge. American Journal of Obstetrics and Gynecology, 2017. 216:1(Supplement 1): Abstract 704, S411-S412.

  BACKGROUND

MeSH Terms

Interventions

Oxycodone

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Mona Prasad, DO

  Mount Carmel Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants and investigators will be aware of the arm to which they have been assigned.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: June 5, 2017
• Study Start: June 16, 2017
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: July 2, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)