Conditioned Open Label Placebo for Postoperative Pain Management

Not Applicable

Recruiting

• Conditions: Pain, Postoperative

• Registration Number: NCT06107595
• Lead Sponsor: Centre de Médecine Intégrative et Complémentaire (CEMIC)

Brief Summary

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).

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 Timeline

• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-10-24
• Study First Posted: 2023-10-30
• Study Start: 2024-01-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 222

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Opioids consumption	17 days	Cumulative opioids intake as postoperative consumption (in MgMeq)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre de Médecine Intégrative et Complémentaire, Service d'anesthésiologie, CHUV,; 🇨🇭 Lausanne, Vaud, Switzerland