Post-operative Pain Control Clinical Trial
Official title:
Assessing the Impact of the Number of Opiates Prescribed on Post Cesarean Pain Control: A Randomized Controlled Trial
Verified date | September 2020 |
Source | Mount Carmel Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 1, 2020 |
Est. primary completion date | August 1, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mt Carmel Medical Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Mount Carmel Health System |
United States,
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.
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. Review. — View Citation
Pfuntner A, Wier LM, Stocks C. Most Frequent Procedures Performed in U.S. Hospitals, 2011: Statistical Brief #165. 2013 Oct. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Available from http://www.ncbi.nlm.nih.gov/books/NBK174682/ — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Duration of use of narcotic after cesarean | As assessed by the Post Cesarean Pain Control Survey | 7-14 days after surgery | |
Secondary | 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 | |
Secondary | Disposition of unused drug | As assessed by the Post Cesarean Pain Control Survey. | 7-14 days after surgery | |
Secondary | Patient satisfaction with pain control after cesarean delivery | As assessed by the Post Cesarean Pain Control Survey. | 7-14 days after surgery |
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