Clinical trial NCT03359798: RCT of Counseling Intervention on Post-op Opiate Use
Official title: The Effect of a Counseling Intervention on Post-cesarean Section Narcotic Use: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Post-operative Pain
Opioid Use
Cesarean Section
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: quantity of narcotics used in-hospital
timeFrame: 4 days
Secondary outcomes:
measure: quantity acetaminophen used in-hospital
timeFrame: 4 days
measure: quantity ibuprofen used in-hospital
timeFrame: 4 days
measure: quantity ketorolac used in-hospital
timeFrame: 4 days
measure: pain scale in-hospital
timeFrame: 1 day, 4 days
measure: narcotic prescription filled after discharge
timeFrame: 2 weeks
measure: quantity of narcotics taken after discharge
timeFrame: 2 weeks
measure: Edinburgh post-partum depression score
timeFrame: 2 weeks and 6 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: 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.