Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2017-08-18
2020-08-14
Brief Summary
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Detailed Description
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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:
1. Age
2. Race
3. Insurance
4. Repeat cesarean section
5. Classification of cesarean section (scheduled, unscheduled, emergent)
6. Type of skin incision and closure
7. Urine toxicology screen results
8. Tubal ligation at the time of cesarean
9. Anesthesia (General or regional \[epidural, spinal or combined\], if regional, duramorph given)
10. Length of hospital stay
11. Number of refills
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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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
Oxycodone Acetaminophen
Decrease in opioid prescribing for post-operative cesarean pain management
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
Oxycodone Acetaminophen
Decrease in opioid prescribing for post-operative cesarean pain management
Interventions
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Oxycodone Acetaminophen
Decrease in opioid prescribing for post-operative cesarean pain management
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Cesarean section
3. \>/= 18 years of age
Exclusion Criteria
2. \<18 years of age
3. Allergy to hydrocodone, oxycodone, acetaminophen or NSAIDs
4. Contraindication to using medications (i.e hypertensive disorders of pregnancy)
5. Hospitalization \>7 days, which suggest complications that may increase pain and opioid requirements
6. Complications (wound infections, re-explorations, cesarean hysterectomies, etc…)
7. Urine toxicology screen positive for opioids on admission
8. 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
18 Years
FEMALE
Yes
Sponsors
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ProMedica Health System
OTHER
Responsible Party
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James Van Hook
Medical Doctor
Principal Investigators
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James Van Hook, MD
Role: PRINCIPAL_INVESTIGATOR
ProMedica Health System
Locations
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Center for Health Services
Toledo, Ohio, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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IRB #17-064
Identifier Type: -
Identifier Source: org_study_id
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