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COLP: Evaluation of Open-Label Conditioned Placebo Analgesia for Postoperative Opioid Reduction Following Spinal Fusion

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04574388
Collaborator
(none)
51
Enrollment
1
Location
2
Arms
15.3
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: open label placebo
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
51 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Evaluation of Open-Label Conditioned Placebo Analgesia for Postoperative Opioid Reduction Following Spinal Fusion
Actual Study Start Date :
Nov 30, 2018
Actual Primary Completion Date :
Mar 10, 2020
Actual Study Completion Date :
Mar 10, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: open label placebo

participants will take open label placebo pills TID and in conjunction with other PRN analgesics

Other: open label placebo
open label placebo pill
Other Names:
  • non-deceptive placebo

    		•
    No Intervention: treatment as usual

    participants will take PRN analgesics as usual

    Outcome Measures

    Primary Outcome Measures

    1. self administration of PRN opioids [day 3-17]

      daily report of post-discharge opioid use in sub-acute postoperative period, converted into morphine milligram equivalents

    2. acute postoperative pain [day 3-17]

      daily brief pain inventory (BPI)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • (1) aged 18-75 years, (2) scheduled for spinal fusion surgery up to, and including 4 levels, (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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brigham and Women's Hospital Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Brigham and Women's Hospital

    Investigators

    • Principal Investigator: Kristin Schreiber, M.D., Ph.D., Brigham and Women's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kristin Schreiber, Assistant Professor, Principle Investigator, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT04574388
    Other Study ID Numbers:
    • 2018P000854
    First Posted:
    Oct 5, 2020
    Last Update Posted:
    Sep 13, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kristin Schreiber, Assistant Professor, Principle Investigator, Brigham and Women's Hospital
    open label placebo

    Study Results

    No Results Posted as of Sep 13, 2021