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

Opioid Use, Unspecified Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03959969
• Other study ID #: STUDY00000260
• Status: Completed
• Phase: N/A
• Start date: July 17, 2019
• Est. completion date: January 11, 2020

Study information

• Verified date: March 2021
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 11, 2020
• Est. primary completion date: December 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use, Unspecified

Intervention

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

Drug:
• Ibuprofen
Prescription given for forty tablets of ibuprofen 600 mg every 6 hours as needed for pain.
• Oxycodone
Prescription given for twenty tablets of oxycodone 5 mg every 4 hours as needed for pain.

Locations

Country	Name	City	State
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Total number of oxycodone tablets used inpatient	Total oxycodone tablets used during patient's inpatient stay after cesarean delivery.	3 days
Secondary	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)