Pain, Postoperative
Conditions
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.
Interventions
BEHAVIORALPlacebo
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
Sponsors
Centre de Médecine Intégrative et Complémentaire (CEMIC)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioids consumption | 17 days | Cumulative opioids intake as postoperative consumption (in MgMeq) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Time to Opioid withdrawal (in days) | until the 6 months follow-up | Time to Opioid withdrawal calculated for COLP compared to treatment as usual |
| 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) |
| Mobility | 17 days | Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=best ability to move) |
Countries
Switzerland
Contacts
Primary ContactAurore Fernandez, PhD
Outcome results
None listed