- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03355248
Satisfaction Following Cesarean Section
The Effect of Decreased Opioid Prescribing on Pain Control and Patient Satisfaction Following Cesarean Section
Study Overview
Status
Intervention / Treatment
Detailed Description
Presently, the standard of care at our practice is that the discharging physician decides the type and amount of opioid medication to prescribe a patient following a cesarean section. After informed consent has been obtained, patients will be enrolled in our randomized-control, equivalence study. The experimental group will be prescribed 20 oxycodone-acetaminophen and the control group will be prescribed 28 oxycodone-acetaminophen at the time of discharge. Both groups will also be provided with a handout on non-opioid analgesia. The groups will be assigned randomly in blocks. The investigators will recruit patients either in the clinic, if participants are to have a scheduled cesarean section, or at some time during the hospital admission for delivery. The satisfaction survey and pain scale will be administered at the postoperative check by the clinic staff and providers. If the patient does not show up for their postoperative visit, 3 attempts total will be made by an investigator to reach the patient and administer both surveys by phone within 2 weeks of discharge. A preliminary analysis of the data will be done once half the study patients have been recruited. First, block randomization will help limit discrepancies between groups.
Subject evaluation will generally be limited to no more than 3 weeks following surgery. Evaluations will occur at the postoperative visit via two surveys (see below). If the patient does not show up for the clinic visit, 3 attempts will be made by an investigator to reach the patient and administer both surveys by phone within 2 weeks of discharge.
Variables of interest:
- Age
- Race
- Insurance
- Repeat cesarean section
- Classification of cesarean section (scheduled, unscheduled, emergent)
- Type of skin incision and closure
- Urine toxicology screen results
- Tubal ligation at the time of cesarean
- Anesthesia (General or regional [epidural, spinal or combined], if regional, duramorph given)
- Length of hospital stay
- Number of refills
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Toledo, Ohio, United States, 43606
- Center for Health Services
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Center for health services (CHS) patient
- Cesarean section
- >/= 18 years of age
Exclusion Criteria:
- Non-CHS patients (i.e. regional or private)
- <18 years of age
- Allergy to hydrocodone, oxycodone, acetaminophen or NSAIDs
- Contraindication to using medications (i.e hypertensive disorders of pregnancy)
- Hospitalization >7 days, which suggest complications that may increase pain and opioid requirements
- Complications (wound infections, re-explorations, cesarean hysterectomies, etc…)
- Urine toxicology screen positive for opioids on admission
- Recent use as defined by either patient reported use of opioids within the last 30 days or an Ohio Automated Rx Reporting System (OARRS) reports that shows prescription of opioids within 30 days of admission for delivery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control Group - 28
The control group (post-operative cesarean section) will be prescribed 28 Oxycodone Acetaminophen at the time of discharge.
Both groups will also be provided with a handout on non-opioid analgesia.
The groups will be assigned randomly in blocks.
Specifically, the first half of the patients will automatically be placed in the experimental arm and the second half into the control arm of the study
|
Decrease in opioid prescribing for post-operative cesarean pain management
Other Names:
|
Experimental: Experimental - 20
The experimental group (post-operative cesarean section) will be prescribed 20 Oxycodone Acetaminophen at the time of discharge.
Both groups will also be provided with a handout on non-opioid analgesia.
The groups will be assigned randomly in blocks.
Specifically, the first half of the patients will automatically be placed in the experimental arm and the second half into the control arm of the study
|
Decrease in opioid prescribing for post-operative cesarean pain management
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-cesarean pain management
Time Frame: 1 week post-op cesarean
|
Our main aim is to determine the effect of decreased opioid prescribing on pain control following cesarean section.
Our hypothesis is that despite decreased opioid prescribing [20 oxycodone-acetaminophen (5/325mg)] following cesarean section, pain scores will be equivalent to the control group [28 oxycodone-acetaminophen (5/325mg)].
Pain control will be measured by an 11-point numeric scale.
|
1 week post-op cesarean
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-cesarean patient satisfaction with management
Time Frame: 1 week post-op cesarean
|
Secondary outcomes include patient satisfaction as assessed by a survey
|
1 week post-op cesarean
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James Van Hook, MD, ProMedica Health System
Publications and helpful links
General Publications
- Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.
- Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.
- Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths - United States, 2010-2015. MMWR Morb Mortal Wkly Rep. 2016 Dec 30;65(50-51):1445-1452. doi: 10.15585/mmwr.mm655051e1.
- Manchikanti L, Helm S 2nd, Fellows B, Janata JW, Pampati V, Grider JS, Boswell MV. Opioid epidemic in the United States. Pain Physician. 2012 Jul;15(3 Suppl):ES9-38.
- Bateman BT, Cole NM, Maeda A, Burns SM, Houle TT, Huybrechts KF, Clancy CR, Hopp SB, Ecker JL, Ende H, Grewe K, Raposo Corradini B, Schoenfeld RE, Sankar K, Day LJ, Harris L, Booth JL, Flood P, Bauer ME, Tsen LC, Landau R, Leffert LR. Patterns of Opioid Prescription and Use After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):29-35. doi: 10.1097/AOG.0000000000002093.
- 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.
- Prabhu M, McQuaid-Hanson E, Hopp S, Burns SM, Leffert LR, Landau R, Lauffenburger JC, Choudhry NK, Kaimal A, Bateman BT. A Shared Decision-Making Intervention to Guide Opioid Prescribing After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):42-46. doi: 10.1097/AOG.0000000000002094.
- Hill MV, Stucke RS, McMahon ML, Beeman JL, Barth RJ Jr. An Educational Intervention Decreases Opioid Prescribing After General Surgical Operations. Ann Surg. 2018 Mar;267(3):468-472. doi: 10.1097/SLA.0000000000002198.
- Centers for Disease Control and Prevention. Wide-ranging Online Data for Epidemiologic Research (WONDER), Multiple-Cause-of-Death file, 2000-2014. 2015. Available at: http://www.cdc.gov/nchs/data/health_ policy/AADR_drug_poisoning_involving_OA_Heroin_US_2000-2014.pdf. Accessed June 9, 2017.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pregnancy Complications
- Pain, Postoperative
- Puerperal Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antipyretics
- Analgesics, Opioid
- Narcotics
- Acetaminophen
- Oxycodone
- Acetaminophen, hydrocodone drug combination
Other Study ID Numbers
- IRB #17-064
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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