Post-operative PainNCT03359798
RCT of Counseling Intervention on Post-op Opiate Use
A study testing Narcotic counseling script and Post-partum depression counseling script in people with Post-operative Pain and Opioid Use, run by Brigham and Women's Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain, Opioid Use, Cesarean Section
- What is being tested?
- Narcotic counseling script and Post-partum depression counseling script
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Delivery by scheduled cesarean section at Brigham and Women's Hospital
Who cannot join
- 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
Show all 9Show fewer
- Myomectomy at the time of cesarean section
- Non English-speaking
- Patient of the investigator performing the recruitment
About this study
Official title: 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.
Read the 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.
- Conditions
- Post-operative Pain, Opioid Use, Cesarean Section
- Being tested
- Narcotic counseling script, Post-partum depression counseling script
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narcotic counseling scriptBehavioural
Script regarding post-cesarean section narcotic use
Post-partum depression counseling scriptBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Narcotic counseling script | Experimental | Study participants will be read a script regarding post-cesarean section narcotic use. Receives: Behavioral: Narcotic counseling script |
| Post-partum depression counseling script | Sham comparator | 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. Receives: Behavioral: Post-partum depression counseling script |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantity of narcotics used in-hospital
Measured: 4 days
Secondary outcomes (7)
quantity acetaminophen used in-hospital
Measured: 4 days
quantity ibuprofen used in-hospital
Measured: 4 days
quantity ketorolac used in-hospital
Measured: 4 days
pain scale in-hospital
Measured: 1 day, 4 days
narcotic prescription filled after discharge
Measured: 2 weeks
quantity of narcotics taken after discharge
Measured: 2 weeks
Edinburgh post-partum depression score
Measured: 2 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start1 Dec 2017 (estimated)
- Primary completion30 Jun 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Why it stopped: Change in practice patterns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian N Robinson, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359798
- Sponsor's protocol ID
- 2017P000792
- Status last verified
- Sep 2019
- First submitted
- 21 Nov 2017
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 32871021
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Counseling Intervention on Post-cesarean Section Narcotic Use: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03359798
- Acronym / sponsor ID
- 2017P000792
- Conditions
- Post-operative Pain, Opioid Use, Cesarean Section
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in practice patterns
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narcotic counseling script | Experimental | Behavioral: Narcotic counseling scriptStudy participants will be read a script regarding post-cesarean section narcotic use. |
| Post-partum depression counseling script | Sham comparator | Behavioral: Post-partum depression counseling scriptStudy 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Delivery by scheduled cesarean section at Brigham and Women's Hospital
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narcotic counseling scriptScript regarding post-cesarean section narcotic use | Behavioural | Narcotic counseling script |
| Post-partum depression counseling scriptStudy 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. | Behavioural | Post-partum depression counseling script |
Primary outcome
quantity of narcotics used in-hospital
Time frame: 4 days
7 secondary outcomes
quantity acetaminophen used in-hospital
Time frame: 4 days
quantity ibuprofen used in-hospital
Time frame: 4 days
quantity ketorolac used in-hospital
Time frame: 4 days
pain scale in-hospital
Time frame: 1 day, 4 days
narcotic prescription filled after discharge
Time frame: 2 weeks
quantity of narcotics taken after discharge
Time frame: 2 weeks
Edinburgh post-partum depression score
Time frame: 2 weeks and 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Derived from this study: PubMed 32871021Zimpel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Narcotic counseling script and Post-partum depression counseling script in people with Post-operative Pain and Opioid Use, run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quantity of narcotics used in-hospital (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03359798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.