RCT of Counseling Intervention on Post-op Opiate Use

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03359798
• Other study ID #: 2017P000792
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: September 2019
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Opioid Use
• Pain, Postoperative
• Post-operative Pain

Intervention

Behavioral:
• Narcotic counseling script
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quantity of narcotics used in-hospital		4 days
Secondary	quantity acetaminophen used in-hospital		4 days
Secondary	quantity ibuprofen used in-hospital		4 days
Secondary	quantity ketorolac used in-hospital		4 days
Secondary	pain scale in-hospital		1 day, 4 days
Secondary	narcotic prescription filled after discharge		2 weeks
Secondary	quantity of narcotics taken after discharge		2 weeks
Secondary	Edinburgh post-partum depression score		2 weeks and 6 weeks