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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
222
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
Centre de Médecine Intégrative et Complémentaire, Service d'anesthésiologie, CHUV,
Lausanne, Canton of Vaud, Switzerland
RECRUITINGOpioids consumption
Cumulative opioids intake as postoperative consumption (in MgMeq)
Time frame: 17 days
Time to Opioid withdrawal (in days)
Time to Opioid withdrawal calculated for COLP compared to treatment as usual
Time frame: until the 6 months follow-up
Postoperative pain intensity
Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=worst pain)
Time frame: 17 days
Satisfaction with postoperative management
Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=highest satisfaction)
Time frame: 17 days
Mobility
Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=best ability to move)
Time frame: 17 days
Sense of agency
Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=best sense of agency)
Time frame: 17 days
Side effects intensity
Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=worst intensity)
Time frame: 17 days
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