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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efficacy of conditioned open label placebo pill | Experimental | On postoperative day 0, participant will self-administer one OLP with all opioid analgesics (whether administered intravenously or orally). This pairing will be done from postoperative day 0 to postoperative day 17. Starting on postoperative day 2, participants take 3 scheduled placebo doses (pills or inhalation) every day, at 3 convenient times. In parallel, the OLP pairing to standard and rescue doses of opioids will continue. The patients are told to continue taking both scheduled standalone COLP and paired COLP (if needed) until postoperative day 17. |
|
| Efficacy of conditioned open label placebo odor | Experimental | 1 drops of clove oil (i.e. eugenol) will be disposed on a cotton and inserted into a stick. The patients will be asked to actively smell them by sniffing using a stick of inhalation. On postoperative day 0, participant will self-administer one OLP with all opioid analgesics (whether administered intravenously or orally). This pairing will be done from postoperative day 0 to postoperative day 17. On postoperative day 2, participants take 3 scheduled placebo doses (pills or inhalation) every day, at 3 convenient times. In parallel, the OLP pairing to standard and rescue doses of opioids will continue. The patients are told to continue taking both scheduled standalone COLP and paired COLP (if needed) until postoperative day 17 |
|
| Standard of care | Active Comparator | Usual postoperative pain management, relying mainly on opioids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Behavioral | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioids consumption | Cumulative opioids intake as postoperative consumption (in MgMeq) | 17 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Opioid withdrawal (in days) | Time to Opioid withdrawal calculated for COLP compared to treatment as usual | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aurore Fernandez, PhD | Contact | +41 79 556 66 91 | aurore.fernandez@chuv.ch |
| Name | Affiliation | Role |
|---|---|---|
| Chantal Berna Renella, Prof | Centre de Médecine Intégrative et Complémentaire, Lausanne University hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Médecine Intégrative et Complémentaire, Service d'anesthésiologie, CHUV, | Recruiting | Lausanne | Canton of Vaud | 1011 | Switzerland |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| 17 days |
| Satisfaction with postoperative management | Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=highest satisfaction) | 17 days |
| Mobility | Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=best ability to move) | 17 days |
| Sense of agency | Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=best sense of agency) | 17 days |
| Side effects intensity | Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=worst intensity) | 17 days |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |