RCT of Counseling Intervention on Post-op Opiate Use

NCT ID: NCT03359798

Last Updated: 2019-09-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2018-12-01

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.

Conditions

Post-operative Pain; Opioid Use; Cesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Narcotic counseling script

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

Group Type: EXPERIMENTAL

Narcotic counseling script

Intervention Type: BEHAVIORAL

Script regarding post-cesarean section narcotic use

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.

Group Type: SHAM_COMPARATOR

Post-partum depression counseling script

Intervention Type: BEHAVIORAL

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.

Interventions

Narcotic counseling script

Script regarding post-cesarean section narcotic use

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Julian N Robinson

Chief of Obstetrics, Associate Professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 32871021 (View on PubMed)

Other Identifiers

2017P000792

Identifier Type: -

Identifier Source: org_study_id