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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03959969
Other study ID # STUDY00000260
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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