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RCT of Counseling Intervention on Post-op Opiate Use

Primary Purpose

Post-operative Pain, Opioid Use, Cesarean Section

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Narcotic counseling script
Post-partum depression counseling script
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-operative Pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Delivery by scheduled cesarean section at Brigham and Women's Hospital

Exclusion Criteria:

  • Answer "yes" to the question: "Has any provider talked to you this pregnancy about medications for pain control after your c-section?"
  • History of opiate abuse
  • Use of chronic opiates, benzodiazepines or gabapentin
  • History of chronic pain
  • Cesarean hysterectomy
  • Vertical skin incision
  • Myomectomy at the time of cesarean section
  • Non English-speaking
  • Patient of the investigator performing the recruitment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Narcotic counseling script

    Post-partum depression counseling script

    Arm Description

    Study participants will be read a script regarding post-cesarean section narcotic use.

    Study participants will be read a script of the same length, and much of the same wording as the experimental script. However, this script's content is focused on post-partum depression.

    Outcomes

    Primary Outcome Measures

    quantity of narcotics used in-hospital

    Secondary Outcome Measures

    quantity acetaminophen used in-hospital
    quantity ibuprofen used in-hospital
    quantity ketorolac used in-hospital
    pain scale in-hospital
    narcotic prescription filled after discharge
    quantity of narcotics taken after discharge
    Edinburgh post-partum depression score

    Full Information

    First Posted
    November 21, 2017
    Last Updated
    September 18, 2019
    Sponsor
    Brigham and Women's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03359798
    Brief Title
    RCT of Counseling Intervention on Post-op Opiate Use
    Official Title
    The Effect of a Counseling Intervention on Post-cesarean Section Narcotic Use: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Change in practice patterns
    Study Start Date
    December 1, 2017 (Anticipated)
    Primary Completion Date
    June 30, 2018 (Anticipated)
    Study Completion Date
    December 1, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brigham and Women's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is a randomized controlled trial to investigate the effect of a simple counseling intervention on post-operative narcotic requirements, with the hypothesis that women receiving this intervention will use fewer narcotics for pain management following cesarean section.
    Detailed Description
    All women undergoing scheduled cesarean section at Brigham and Women's Hospital who meet eligibility for the study will be approached in the pre-operative area on the Labor and Delivery floor prior to her scheduled cesarean section. For eligible patients interested in participation, consent will be obtained, and the participant will be randomized to receive either an intervention script containing counseling about post-op narcotic use, or the control script containing information regarding post-partum depression. This script will then be read to the participant in the pre-operative area prior to her scheduled cesarean section. Two types of data will then be collected: inpatient data, and outpatient data. Regarding inpatient data, study investigators will collect information from the electronic medical record about the quantity of narcotics used in the hospital, pain scores while in the hospital, and demographic information. In terms of outpatient data, study investigators will contact participants at 2 weeks and 6 weeks post-partum with questions from the Edinburgh post-partum depression scale score and the WHOQOL-BREF scale score, along with questions regarding their narcotic use at home. Specifically, participants will be asked during the informed consent process whether they agree to 1) receive an email with a brief online survey at 2 weeks post-partum, and 2) receive a follow-up phone call within the week after the email survey was sent if survey responses are not received, 3) receive a second email with a brief online survey at 6 weeks post-partum, 4) receive a follow-up phone call within the week after the second email survey was sent if survey responses are not received. Surveys will be emailed to participants using the Partner's REDCap service that is located behind the Partner's firewall. Investigators will also mine information about each participant's narcotic use from the MassPAT prescription monitoring database. The endpoint of the study will be enrollment of our desired sample size.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-operative Pain, Opioid Use, Cesarean Section

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Narcotic counseling script
    Arm Type
    Experimental
    Arm Description
    Study participants will be read a script regarding post-cesarean section narcotic use.
    Arm Title
    Post-partum depression counseling script
    Arm Type
    Sham Comparator
    Arm Description
    Study participants will be read a script of the same length, and much of the same wording as the experimental script. However, this script's content is focused on post-partum depression.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Narcotic counseling script
    Intervention Description
    Script regarding post-cesarean section narcotic use
    Intervention Type
    Behavioral
    Intervention Name(s)
    Post-partum depression counseling script
    Intervention Description
    Study participants will be read a script of the same length, and much of the same wording as the experimental script. However, this script's content is focused on post-partum depression.
    Primary Outcome Measure Information:
    Title
    quantity of narcotics used in-hospital
    Time Frame
    4 days
    Secondary Outcome Measure Information:
    Title
    quantity acetaminophen used in-hospital
    Time Frame
    4 days
    Title
    quantity ibuprofen used in-hospital
    Time Frame
    4 days
    Title
    quantity ketorolac used in-hospital
    Time Frame
    4 days
    Title
    pain scale in-hospital
    Time Frame
    1 day, 4 days
    Title
    narcotic prescription filled after discharge
    Time Frame
    2 weeks
    Title
    quantity of narcotics taken after discharge
    Time Frame
    2 weeks
    Title
    Edinburgh post-partum depression score
    Time Frame
    2 weeks and 6 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Delivery by scheduled cesarean section at Brigham and Women's Hospital Exclusion Criteria: Answer "yes" to the question: "Has any provider talked to you this pregnancy about medications for pain control after your c-section?" History of opiate abuse Use of chronic opiates, benzodiazepines or gabapentin History of chronic pain Cesarean hysterectomy Vertical skin incision Myomectomy at the time of cesarean section Non English-speaking Patient of the investigator performing the recruitment

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32871021
    Citation
    Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.
    Results Reference
    derived

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    RCT of Counseling Intervention on Post-op Opiate Use

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