NCT06107595

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 8, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

1.4 years

First QC Date

October 18, 2023

Last Update Submit

February 27, 2024

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Opioids consumption

    Cumulative opioids intake as postoperative consumption (in MgMeq)

    17 days

Secondary Outcomes (6)

  • Time to Opioid withdrawal (in days)

    until the 6 months follow-up

  • Postoperative pain intensity

    17 days

  • Satisfaction with postoperative management

    17 days

  • Mobility

    17 days

  • Sense of agency

    17 days

  • +1 more secondary outcomes

Study Arms (3)

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.

Behavioral: Placebo

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

Behavioral: Placebo

Standard of care

ACTIVE COMPARATOR

Usual postoperative pain management, relying mainly on opioids

Behavioral: Placebo

Interventions

PlaceboBEHAVIORAL

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

Efficacy of conditioned open label placebo odorEfficacy of conditioned open label placebo pillStandard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Chantal Berna Renella, Prof

    Centre de Médecine Intégrative et Complémentaire, Lausanne University hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurore Fernandez, PhD

CONTACT

+41 79 556 66 91‬aurore.fernandez@chuv.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 18, 2023

First Posted

October 30, 2023

Study Start

January 8, 2024

Primary Completion

June 1, 2025

Study Completion

December 1, 2025

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations

CH(1)