RCT of Counseling Intervention on Post-op Opiate Use

Mass General Brigham

Status: Withdrawn

Conditions: Cesarean Section; Post-operative Pain; Opioid Use

Treatments: Behavioral: Post-partum depression counseling script; Behavioral: Narcotic counseling script

Study type: Interventional

Funder types: Other

Identifiers

NCT03359798

2017P000792

Details and patient eligibility

About

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 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.

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Narcotic counseling script

Experimental group

Description:

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

Treatment:

Behavioral: Narcotic counseling script

Post-partum depression counseling script

Sham Comparator group

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.

Treatment:

Behavioral: Post-partum depression counseling script