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

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use, Unspecified
• Intervention / Treatment: Other: Educational video; Drug: Ibuprofen; Drug: Oxycodone; Other: Standard of care

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Educational Video Recipients; 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; 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.; Drug: Ibuprofen; Prescription given for forty tablets of ibuprofen 600 mg every 6 hours as needed for pain.; Other Names: Advil; Drug: Oxycodone; Prescription given for twenty tablets of oxycodone 5 mg every 4 hours as needed for pain.
Active Comparator: Standard of Care Recipients; 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.	Drug: Ibuprofen; Prescription given for forty tablets of ibuprofen 600 mg every 6 hours as needed for pain.; Other Names: Advil; Drug: Oxycodone; Prescription given for twenty tablets of oxycodone 5 mg every 4 hours as needed for pain.; Other: Standard of care; The standard of care discharge instructions for postoperative patients after cesarean section that are provided at the institution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment score from numeric pain intensity scale at seven days after cesarean delivery	Using an universal pain assessment tool of a numeric pain intensity scale, patients will be asked their pain score seven days after cesarean delivery (postpartum day 7). The numeric pain intensity scale is 0-10, with 0 being no pain and 10 being the worst pain possible.	7 days after cesarean delivery (postpartum day number 7)
Adjunct medication use at seven days after cesarean delivery	This is to determine use of adjunct medications such as ibuprofen and Tylenol in the participants in both arms, 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	Assessment of overall pain management satisfaction seven days after cesarean delivery (postpartum day number 7) with five point Likert scale. The Likert scale ranges from extremely satisfied with pain management to extremely dissatisfied with pain management.	7 days after cesarean delivery (postpartum day number 7)
Pain assessment score from numeric pain intensity scale at fourteen days after cesarean delivery	Using an universal pain assessment tool of a numeric pain intensity scale, patients will be asked their pain score fourteen days after cesarean delivery (postpartum day 14).The numeric pain intensity scale is 0-10, with 0 being no pain and 10 being the worst pain possible.	14 days after cesarean delivery (postpartum day number 14)
Adjunct medication use at fourteen days after cesarean delivery	This is to determine use of adjunct medications such as ibuprofen and Tylenol in the participants in both arms, fourteen days after cesarean delivery.	14 days after cesarean delivery (postpartum day number 14)
Overall pain management satisfaction using Likert scale fourteen days after cesarean delivery	Assessment of overall pain management satisfaction fourteen days after cesarean delivery (postpartum day number 14) with five point Likert scale. The Likert scale ranges from extremely satisfied with pain management to extremely dissatisfied with pain management.	14 days after cesarean delivery (postpartum day number 14)
Total number of oxycodone tablets used inpatient	Total oxycodone tablets used during patient's inpatient stay after cesarean delivery.	3 days
Number of oxycodone tablets used seven days after cesarean delivery	This is the total number of oxycodone tablets used by participants in each arm seven days after cesarean delivery (postpartum day number 7).	7 days after cesarean delivery (postpartum day number 7)

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute
• Investigators: Principal Investigator: Sara Iqbal, MD, Medstar Washington Hospital Center

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2019
• Primary Completion (Actual): December 28, 2019
• Study Completion (Actual): January 11, 2020

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 30, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Ibuprofen; Oxycodone
• Other Study ID Numbers: STUDY00000260

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No