NCT06107595

Conditioned Open Label Placebo for Postoperative Pain Management

A Randomized Controlled Trial Evaluating the Efficacy of Conditioned Open Label Placebo (COLP) to Limit Opioid Reliance for Postoperative Pain Management

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 222 (estimated)
• Sponsor: Centre de Médecine Intégrative et Complémentaire (CEMIC) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
BEHAVIORAL	Placebo	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

Timeline

• Start date: 2024-01-08
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2023-10-30
• Last updated: 2024-02-28

Locations

1 site across 1 country: Switzerland