RCT of Counseling Intervention on Post-op Opiate Use

The Effect of a Counseling Intervention on Post-cesarean Section Narcotic Use: a Randomized Controlled Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Cesarean Section; Opioid Use; Post-operative Pain
• Intervention / Treatment: Behavioral: Narcotic counseling script; Behavioral: Post-partum depression counseling script

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Narcotic counseling script; Study participants will be read a script regarding post-cesarean section narcotic use.	Behavioral: Narcotic counseling script; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
quantity of narcotics used in-hospital	4 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2017
• Primary Completion (Anticipated): June 30, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): December 2, 2017

Study Record Updates

• Last Update Posted (Actual): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics
• Other Study ID Numbers: 2017P000792

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No