Conditioned Open Label Placebo for Postoperative Pain Management

Last updated: February 27, 2024
Sponsor: Centre de Médecine Intégrative et Complémentaire (CEMIC)
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Placebo

Clinical Study ID

NCT06107595
2023-01664
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Cognitive impairment (MOCA score <26)
  • Inability to engage in the intervention of the study e.g. inability to communicate inFrench without a translator, severe hearing impairment without any hearing aidavailable at the time of intervention, anosmia or intolerance to eugenol.
  • Acute psychiatric (e.g. psychotic or suicidal ideation) or somatic (e.g. unstablecardio-respiratory condition) co-morbidity preventing full engagement duringintervention
  • Opioid use disorder (toxicomania) or contraindication to pain management using opioids (allergy, refusal, ...)
  • Intolerance to placebo ingredients

Study Design

Total Participants: 222
Treatment Group(s): 1
Primary Treatment: Placebo
Phase:
Study Start date:
January 08, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Centre de Médecine Intégrative et Complémentaire, Service d'anesthésiologie, CHUV,

    Lausanne, Vaud 1011
    Switzerland

    Active - Recruiting

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