RCT of Counseling Intervention on Post-op Opiate Use
Primary Purpose
Post-operative Pain, Opioid Use, Cesarean Section
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Narcotic counseling script
Post-partum depression counseling script
Sponsored by
About this trial
This is an interventional prevention trial for Post-operative Pain
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Narcotic counseling script
Post-partum depression counseling script
Arm Description
Study participants will be read a script regarding post-cesarean section narcotic use.
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.
Outcomes
Primary Outcome Measures
quantity of narcotics used in-hospital
Secondary Outcome Measures
quantity acetaminophen used in-hospital
quantity ibuprofen used in-hospital
quantity ketorolac used in-hospital
pain scale in-hospital
narcotic prescription filled after discharge
quantity of narcotics taken after discharge
Edinburgh post-partum depression score
Full Information
NCT ID
NCT03359798
First Posted
November 21, 2017
Last Updated
September 18, 2019
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03359798
Brief Title
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Change in practice patterns
Study Start Date
December 1, 2017 (Anticipated)
Primary Completion Date
June 30, 2018 (Anticipated)
Study Completion Date
December 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain, Opioid Use, Cesarean Section
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Narcotic counseling script
Arm Type
Experimental
Arm Description
Study participants will be read a script regarding post-cesarean section narcotic use.
Arm Title
Post-partum depression counseling script
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Narcotic counseling script
Intervention Description
Script regarding post-cesarean section narcotic use
Intervention Type
Behavioral
Intervention Name(s)
Post-partum depression counseling script
Intervention 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.
Primary Outcome Measure Information:
Title
quantity of narcotics used in-hospital
Time Frame
4 days
Secondary Outcome Measure Information:
Title
quantity acetaminophen used in-hospital
Time Frame
4 days
Title
quantity ibuprofen used in-hospital
Time Frame
4 days
Title
quantity ketorolac used in-hospital
Time Frame
4 days
Title
pain scale in-hospital
Time Frame
1 day, 4 days
Title
narcotic prescription filled after discharge
Time Frame
2 weeks
Title
quantity of narcotics taken after discharge
Time Frame
2 weeks
Title
Edinburgh post-partum depression score
Time Frame
2 weeks and 6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
32871021
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.
Results Reference
derived
Learn more about this trial
RCT of Counseling Intervention on Post-op Opiate Use
We'll reach out to this number within 24 hrs