Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04574388 |
| Other study ID # |
2018P000854 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 30, 2018 |
| Est. completion date |
March 10, 2020 |
Study information
| Verified date |
September 2021 |
| Source |
Brigham and Women's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This research aims to understand the impact of conditioned open label placebo (COLP) on
opioid consumption and pain after surgery. The hypothesis being tested is that by pairing a
non-deceptive placebo pill with regularly prescribed pain killers after surgery, will allow
reduction in opioids taken while maintaining the same level of analgesia.
Description:
Participants will be enrolled at preoperative clinic.
Inclusion criteria:
1. aged 18-75 years
2. scheduled for spinal fusion surgery
3. able to comprehend and willingness to participate in COLP
4. willingness to undergo psychophysical and psychosocial testing
5. willingness to participate in long-term follow-up.
Exclusion criteria:
1. delirium, psychosis, or other cognitive impairment limiting completion of study
procedures
2. non-English speaking
3. contraindication to opioid usage
Preoperative psychosocial and pain questionnaires will be completed using a secure email link
to REDcap, and brief quantitative sensory testing performed.
After completion of preoperative testing, they will be randomized to one of 2 treatments:
COLP or treatment as usual (TAU).
Day of surgery: Patient will undergo scheduled spinal fusion and admitted for post-operative
recovery as per normal surgical management. No restrictions on intraoperative anesthetics or
post-operative pain management options will be made. Intraoperative medication use, including
opioids, as well as post-operative opioid consumption and pain scores will be extracted from
the medical record.
Inpatient and outpatient postoperative period: The study investigator or research assistant
(RA) will train the participant and nursing staff in the self-administration of COLP with
each analgesic administration in hospital, beginning on POD 0, pairing one open label placebo
pill with each analgesic medication administration. Beginning on POD 2, patients will
additionally be instructed to take a scheduled placebo pill at least 3 times/day, and in
conjunction with their ongoing instances of PRN opioid utilization. Opioid administration and
pain scores will be recorded in a daily diary, which the RA will help fill out on POD1 and 2
with them. At hospital discharge, the patients' bottle of placebo pills will be replenished.
Patients will be instructed to continue scheduled and PRN use of opioids, and encouraged to
use placebo pills. After discharge, the number of placebo and opioid pills that they use, as
well as average pain at rest and with movement each day will be collected for up to 21 days
via email linking to Redcap system. If preferred, patients will answer questions through
daily SMS TEXT or telephone call, using a secure study phone. To protect patient's privacy
there will be no identifiable information in the text messages. The SMS texts will be sent
from a dedicated study phone that is MobileIron enabled. MobileIron is software used by
Partners HealthCare that allows for more secure data management.
Follow-up visit: At surgical follow-up visit, patients will repeat baseline testing and
participants in the COLP group will undergo a 15-minute semi-structured interview to
determine the patient's experience with managing post-operative pain with COLP. Long term
follow-up on pain, psychosocial impact and opioid use will be accomplished using the Redcap
email survey system.
