Conditioned Open Label Placebo for Postoperative Pain Management (COLP)

A Randomized Controlled Trial Evaluating the Efficacy of Conditioned Open Label Placebo (COLP) to Limit Opioid Reliance for Postoperative Pain Management

The primary objective is to evaluate the efficacy of two Conditioned Open Label Placebos (COLP): COLP pill and COLP odor to reduce opioid intake for postoperative (thoracic and spinal surgery) pain management compared to the opioid only usual treatment (TAU).

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative
• Intervention / Treatment: Behavioral: Placebo

Detailed Description

Patients, eligible for an elective thoracic or spinal surgery, will be randomized into either standard of care, COLP_pill or COLP_odor. Patients in COLP groups will be asked to pair each opioid intake with an open label placebo intake (either a pill or an inhalation) for postoperative (POD) day 0 to 17. From POD 2, patients in the intervention arms will be additionally asked to take OLP alone 3 times a day. Patients will have unrestricted access to pain killers. Patients will daily assess opioid intake, pain intensity, side effects, mobility and sense of agency using a e-dairy.

• Study Type: Interventional
• Enrollment (Estimated): 222
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aurore Fernandez, PhD; Phone Number: +41 79 556 66 91‬; Email: aurore.fernandez@chuv.ch

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Recruiting
      • Centre de Médecine Intégrative et Complémentaire, Service d'anesthésiologie, CHUV,
      • Contact: Aurore Fernandez; Phone Number: 079 556 66 91; Email: aurore.fernandez@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Spinal or thoracic elective surgery for the indications mentioned above
• Able to give informed consent
• Interested in trying COLP as complementary pain management therapy
• Able to fill a e-diary at home

Exclusion Criteria:

• Cognitive impairment (MOCA score <26)
• Inability to engage in the intervention of the study e.g. inability to communicate in French without a translator, severe hearing impairment without any hearing aid available at the time of intervention, anosmia or intolerance to eugenol.
• Acute psychiatric (e.g. psychotic or suicidal ideation) or somatic (e.g. unstable cardio-respiratory condition) co-morbidity preventing full engagement during intervention
• Opioid use disorder (toxicomania) or contraindication to pain management using opioids (allergy, refusal, ...)
• Intolerance to placebo ingredients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Efficacy of conditioned open label placebo pill; On postoperative day 0, participant will self-administer one OLP with all opioid analgesics (whether administered intravenously or orally). This pairing will be done from postoperative day 0 to postoperative day 17. Starting on postoperative day 2, participants take 3 scheduled placebo doses (pills or inhalation) every day, at 3 convenient times. In parallel, the OLP pairing to standard and rescue doses of opioids will continue. The patients are told to continue taking both scheduled standalone COLP and paired COLP (if needed) until postoperative day 17.	Behavioral: Placebo; Participant take 1 dose placebo (odor or pill) on post-op day 0 (POD 0) and 3 placebo dose from POD 2 to POD 17
Experimental: Efficacy of conditioned open label placebo odor; 1 drops of clove oil (i.e. eugenol) will be disposed on a cotton and inserted into a stick. The patients will be asked to actively smell them by sniffing using a stick of inhalation. On postoperative day 0, participant will self-administer one OLP with all opioid analgesics (whether administered intravenously or orally). This pairing will be done from postoperative day 0 to postoperative day 17. On postoperative day 2, participants take 3 scheduled placebo doses (pills or inhalation) every day, at 3 convenient times. In parallel, the OLP pairing to standard and rescue doses of opioids will continue. The patients are told to continue taking both scheduled standalone COLP and paired COLP (if needed) until postoperative day 17	Behavioral: Placebo; Participant take 1 dose placebo (odor or pill) on post-op day 0 (POD 0) and 3 placebo dose from POD 2 to POD 17
Active Comparator: Standard of care; Usual postoperative pain management, relying mainly on opioids	Behavioral: Placebo; Participant take 1 dose placebo (odor or pill) on post-op day 0 (POD 0) and 3 placebo dose from POD 2 to POD 17

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioids consumption	Cumulative opioids intake as postoperative consumption (in MgMeq)	17 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Opioid withdrawal (in days)	Time to Opioid withdrawal calculated for COLP compared to treatment as usual	until the 6 months follow-up
Postoperative pain intensity	Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=worst pain)	17 days
Satisfaction with postoperative management	Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=highest satisfaction)	17 days
Mobility	Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=best ability to move)	17 days
Sense of agency	Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=best sense of agency)	17 days
Side effects intensity	Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=worst intensity)	17 days

Collaborators and Investigators

• Sponsor: Centre de Médecine Intégrative et Complémentaire (CEMIC)
• Investigators: Principal Investigator: Chantal Berna Renella, Prof, Centre de Médecine Intégrative et Complémentaire, Lausanne University hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2023-01664

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No