Clinical trial NCT03959969: Educational Video on Pain Management and Subsequent Opioid Use After Cesarean Delivery
Official title: Educational Video on Pain Management and Subsequent Opioid Use After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use, Unspecified
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of oxycodone tablets used fourteen days after cesarean delivery
timeFrame: A total of 14 days after cesarean delivery (postpartum day number 14)
Secondary outcomes:
measure: Pain assessment score from numeric pain intensity scale at seven days after cesarean delivery
timeFrame: 7 days after cesarean delivery (postpartum day number 7)
measure: Adjunct medication use at seven days after cesarean delivery
timeFrame: 7 days after cesarean delivery (postpartum day number 7)
measure: Overall pain management satisfaction using Likert scale seven days after cesarean delivery
timeFrame: 7 days after cesarean delivery (postpartum day number 7)
measure: Pain assessment score from numeric pain intensity scale at fourteen days after cesarean delivery
timeFrame: 14 days after cesarean delivery (postpartum day number 14)
measure: Adjunct medication use at fourteen days after cesarean delivery
timeFrame: 14 days after cesarean delivery (postpartum day number 14)
measure: Overall pain management satisfaction using Likert scale fourteen days after cesarean delivery
timeFrame: 14 days after cesarean delivery (postpartum day number 14)
measure: Total number of oxycodone tablets used inpatient
timeFrame: 3 days
measure: Number of oxycodone tablets used seven days after cesarean delivery
timeFrame: 7 days after cesarean delivery (postpartum day number 7)
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Sara Iqbal, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: ACOG Committee Opinion No. 742 Summary: Postpartum Pain Management. Obstet Gynecol. 2018 Jul;132(1):252-253. doi: 10.1097/AOG.0000000000002711.
citation: 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.