Clinical trial NCT06107595: Conditioned Open Label Placebo for Postoperative Pain Management
Official title: A Randomized Controlled Trial Evaluating the Efficacy of Conditioned Open Label Placebo (COLP) to Limit Opioid Reliance for Postoperative Pain Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Centre de Médecine Intégrative et Complémentaire (CEMIC)
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Opioids consumption
timeFrame: 17 days
Secondary outcomes:
measure: Time to Opioid withdrawal (in days)
timeFrame: until the 6 months follow-up
measure: Postoperative pain intensity
timeFrame: 17 days
measure: Satisfaction with postoperative management
timeFrame: 17 days
measure: Mobility
timeFrame: 17 days
measure: Sense of agency
timeFrame: 17 days
measure: Side effects intensity
timeFrame: 17 days
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre de Médecine Intégrative et Complémentaire, Service d'anesthésiologie, CHUV,
state: Vaud
Study officials:
affiliation: Centre de Médecine Intégrative et Complémentaire, Lausanne University hospital
name: Chantal Berna Renella, Prof
role: PRINCIPAL_INVESTIGATOR
References: