Using placebos to manage postoperative pain
A Randomized Controlled Trial Evaluating the Efficacy of Conditioned Open Label Placebo (COLP) to Limit Opioid Reliance for Postoperative Pain Management
NA · Centre de Médecine Intégrative et Complémentaire (CEMIC) · NCT06107595
This study is testing if using a special pill or scent along with regular pain medication can help patients after thoracic and spinal surgeries use less opioids and feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 222 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre de Médecine Intégrative et Complémentaire (CEMIC) (other) |
| Locations | 1 site (Lausanne, Vaud) |
| Trial ID | NCT06107595 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two types of Conditioned Open Label Placebos (COLP) - a pill and an odor - in reducing opioid consumption for patients recovering from thoracic and spinal surgeries. Eligible patients will be randomly assigned to receive either standard opioid treatment or one of the COLP interventions, where they will pair their opioid intake with a placebo. Participants will track their opioid use, pain levels, side effects, mobility, and sense of agency through an electronic diary over a period of 17 days post-surgery. The goal is to determine if these placebos can enhance pain management and reduce reliance on opioids.
Who should consider this trial
Good fit: Ideal candidates are adults undergoing elective thoracic or spinal surgery who can provide informed consent and are interested in complementary pain management therapies.
Not a fit: Patients with cognitive impairments, severe psychiatric conditions, or those with opioid use disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce opioid intake and improve pain management for postoperative patients.
How similar studies have performed: While the use of placebos in pain management is a recognized area of interest, this specific approach using Conditioned Open Label Placebos is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lausanne, Vaud
- Centre de Médecine Intégrative et Complémentaire, Service d'anesthésiologie, CHUV, — Lausanne, Vaud, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Chantal Berna Renella, Prof — Centre de Médecine Intégrative et Complémentaire, Lausanne University hospital
- Study coordinator: Aurore Fernandez, PhD
- Email: aurore.fernandez@chuv.ch
- Phone: +41 79 556 66 91
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pain, Postoperative