Conditioned Open Label Placebo for Postoperative Pain Management

Pain, Postoperative Clinical Trial

— COLP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06107595
• Other study ID #: 2023-01664
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Centre de Médecine Intégrative et Complémentaire (CEMIC)
• Contact: Aurore Fernandez, PhD
• Phone: +41 79 556 66 91?
• Email: aurore.fernandez[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 222
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
Switzerland	Centre de Médecine Intégrative et Complémentaire, Service d'anesthésiologie, CHUV,	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre de Médecine Intégrative et Complémentaire (CEMIC)

Country where clinical trial is conducted

Switzerland, 

Outcome

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