Satisfaction Following Cesarean Section

NCT03355248 | Completed DMC

• 1 other identifier: IRB #17-064
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Presently, the standard of care at the investigators' 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 this randomized-controlled 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. These surveys will be stored in a secure location at the clinic. 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. The investigators do not foresee any threats to the external or internal validity of the study. The investigators are taking many measures to limit study bias. First, block randomization will help limit discrepancies between groups. Also, strict adherence to the inclusion and exclusion criteria will also help limit confounders that may make data difficult to interpret, such as non-opioid naïve patients and complications that may potentially increase pain and opioid requirements. Lastly, blinding of patients to the number of pills participants receive will help mitigate patient bias.

Conditions

Pain, Postoperative; Cesarean Section Complications; Postpartum Disorder; Opioid Use

Keywords

postpartum; postoperative cesarean pain management; opioid requirements

Outcome Measures

Primary Outcomes (1)

• Post-cesarean pain management

  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 Outcomes (1)

• Post-cesarean patient satisfaction with management

  1 week post-op cesarean

Study Arms (2)

Control Group - 28

ACTIVE COMPARATOR

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

Other: Oxycodone Acetaminophen

Experimental - 20

EXPERIMENTAL

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

Other: Oxycodone Acetaminophen

Interventions

Oxycodone Acetaminophen OTHER

Decrease in opioid prescribing for post-operative cesarean pain management

Also known as: Percocet

Control Group - 28; Experimental - 20

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Postpartum cesarean patients
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Center for health services (CHS) patient
• Cesarean section
• \>/= 18 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• ProMedica Health System: lead

Study Sites (1)

Center for Health Services

Toledo, Ohio, 43606, United States

Location

Related Publications (9)

• 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.

  BACKGROUND

• 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.

  PMID: 28033313 BACKGROUND

• 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.

  PMID: 28267689 BACKGROUND

• 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.

  PMID: 26824844 BACKGROUND

• 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.

  PMID: 27631771 BACKGROUND

• 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.

  PMID: 28594763 BACKGROUND

• 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.

  PMID: 28594766 BACKGROUND

• 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.

  PMID: 28594762 BACKGROUND

• 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.

  PMID: 22786464 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Puerperal Disorders

Interventions

oxycodone-acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• James Van Hook, MD

  ProMedica Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to the group assignment and are not made aware of what interventions are being assigned, only that pain management and satisfaction are being evaluated
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 28, 2017
• Study Start: August 18, 2017
• Primary Completion: August 14, 2020
• Study Completion: August 14, 2020
• Last Updated: September 18, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)