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

NCT ID: NCT03959969

Last Updated: 2021-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-17

Study Completion Date

2020-01-11

Brief Summary

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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.

Detailed Description

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Conditions

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Opioid Use, Unspecified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Educational video

Intervention Type 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.

Ibuprofen

Intervention Type DRUG

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

Oxycodone

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type OTHER

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

Ibuprofen

Intervention Type DRUG

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

Oxycodone

Intervention Type DRUG

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

Interventions

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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.

Intervention Type OTHER

Standard of care

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

Intervention Type OTHER

Ibuprofen

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

Intervention Type DRUG

Oxycodone

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

Intervention Type DRUG

Other Intervention Names

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Advil

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Sara N. Iqbal

Maternal Fetal Medicine Fellowship Program Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sara Iqbal, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

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Washington Hospital Center

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

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22345943 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 29939935 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34237764 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28594763 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28594762 (View on PubMed)

Other Identifiers

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STUDY00000260

Identifier Type: -

Identifier Source: org_study_id

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