RCT of Counseling Intervention on Post-op Opiate Use

Overview

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.

Full Title of Study: “The Effect of a Counseling Intervention on Post-cesarean Section Narcotic Use: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2018

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.

Interventions

  • Behavioral: Narcotic counseling script
    • Script regarding post-cesarean section narcotic use
  • Behavioral: Post-partum depression counseling script
    • 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.

Arms, Groups and Cohorts

  • Experimental: Narcotic counseling script
    • Study participants will be read a script regarding post-cesarean section narcotic use.
  • Sham Comparator: Post-partum depression counseling script
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • quantity of narcotics used in-hospital
    • Time Frame: 4 days

Secondary Measures

  • quantity acetaminophen used in-hospital
    • Time Frame: 4 days
  • quantity ibuprofen used in-hospital
    • Time Frame: 4 days
  • quantity ketorolac used in-hospital
    • Time Frame: 4 days
  • pain scale in-hospital
    • Time Frame: 1 day, 4 days
  • narcotic prescription filled after discharge
    • Time Frame: 2 weeks
  • quantity of narcotics taken after discharge
    • Time Frame: 2 weeks
  • Edinburgh post-partum depression score
    • Time Frame: 2 weeks and 6 weeks

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Brigham and Women’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Julian N Robinson, Chief of Obstetrics, Associate Professor of Obstetrics and Gynecology – Brigham and Women’s Hospital

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