Educational Video on Pain Management and Subsequent Opioid Use After Cesarean Delivery

NCT03959969 | Completed

• 1 other identifier: STUDY00000260
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial assessing the utility of an educational video on pain management after a cesarean section to reduce opioid use. The educational video will be shown during the patient's postpartum stay and the amount of opioid and adjunct medications will be assessed in those who watched the video compared to those who received the standard of care discharge instructions without the video. Participants will be contacted 7 and 14 days after cesarean birth (post operative day number 7 and number 14) to complete a telephone survey on their overall pain management and to determine how many opioid tablets have been used.

Conditions

Opioid Use, Unspecified

Outcome Measures

Primary Outcomes (1)

• Number of oxycodone tablets used fourteen days after cesarean delivery

  This is the total number of oxycodone tablets used by participants in each arm fourteen days after cesarean delivery (postpartum day number 14).

  A total of 14 days after cesarean delivery (postpartum day number 14)

Secondary Outcomes (8)

• Pain assessment score from numeric pain intensity scale at seven days after cesarean delivery

  7 days after cesarean delivery (postpartum day number 7)

• Adjunct medication use at seven days after cesarean delivery

  7 days after cesarean delivery (postpartum day number 7)

• Overall pain management satisfaction using Likert scale seven days after cesarean delivery

  7 days after cesarean delivery (postpartum day number 7)

• Pain assessment score from numeric pain intensity scale at fourteen days after cesarean delivery

  14 days after cesarean delivery (postpartum day number 14)

• Adjunct medication use at fourteen days after cesarean delivery

  14 days after cesarean delivery (postpartum day number 14)

Study Arms (2)

Educational Video Recipients

EXPERIMENTAL

Participants will be shown educational video on pain management after cesarean delivery on day of discharge. Upon discharge, participants will be given twenty tablets of oxycodone 5 mg by mouth every four hours as needed for pain and forty tablets of ibuprofen 600 mg by mouth every six hours as needed for pain.

Other: Educational video; Drug: Ibuprofen; Drug: Oxycodone

Standard of Care Recipients

ACTIVE COMPARATOR

Participants will be given standard of care discharge instructions for pain management on day of discharge. Upon discharge, participants will be given twenty tablets of oxycodone 5 mg by mouth every four hours as needed for pain and forty tablets of ibuprofen 600 mg by mouth every six hours as needed for pain.

Other: Standard of care; Drug: Ibuprofen; Drug: Oxycodone

Interventions

Educational video OTHER

An educational video on pain management after cesarean section. The educational video was put together by two general obstetrician-gynecologists, two maternal fetal medicine specialists, and a palliative care physician.

Educational Video Recipients

Standard of care OTHER

The standard of care discharge instructions for postoperative patients after cesarean section that are provided at the institution.

Standard of Care Recipients

Ibuprofen DRUG

Prescription given for forty tablets of ibuprofen 600 mg every 6 hours as needed for pain.

Also known as: Advil

Educational Video Recipients; Standard of Care Recipients

Oxycodone DRUG

Prescription given for twenty tablets of oxycodone 5 mg every 4 hours as needed for pain.

Educational Video Recipients; Standard of Care Recipients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Greater than 18 years of age
• Underwent repeat or primary C-section
• Literate in English Language

You may not qualify if:

• Complicated cesarean section including cesarean hysterectomy, bowel injury, bladder injury, and/or take-back
• History of opioid use disorder and/or on chronic opiates in pregnancy
• Contraindications to NSAIDS or acetaminophen

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (5)

• 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

• 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

• Ismail S, Shahzad K, Shafiq F. Observational study to assess the effectiveness of postoperative pain management of patients undergoing elective cesarean section. J Anaesthesiol Clin Pharmacol. 2012 Jan;28(1):36-40. doi: 10.4103/0970-9185.92432.

  PMID: 22345943 BACKGROUND

• ACOG Committee Opinion No. 742 Summary: Postpartum Pain Management. Obstet Gynecol. 2018 Jul;132(1):252-253. doi: 10.1097/AOG.0000000000002711.

  PMID: 29939935 BACKGROUND

• Mokhtari NB, Saeed H, Kawakita T, Huang JC, Iqbal SN. Educational Video on Pain Management and Subsequent Opioid Use After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2021 Aug 1;138(2):253-259. doi: 10.1097/AOG.0000000000004468.

  PMID: 34237764 DERIVED

MeSH Terms

Interventions

Standard of Care; Ibuprofen; Oxycodone

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; 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

• Sara Iqbal, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maternal Fetal Medicine Fellowship Program Director

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 22, 2019
• Study Start: July 17, 2019
• Primary Completion: December 28, 2019
• Study Completion: January 11, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)