Status:
RECRUITING
Conditioned Open Label Placebo for Postoperative Pain Management
Lead Sponsor:
Centre de Médecine Intégrative et Complémentaire (CEMIC)
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18+ years
Phase:
NA
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 ma...
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 inta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT06107595
Start Date
January 8 2024
End Date
December 1 2025
Last Update
February 28 2024
Active Locations (1)
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1
Centre de Médecine Intégrative et Complémentaire, Service d'anesthésiologie, CHUV,
Lausanne, Canton of Vaud, Switzerland, 1011