Pain, PostoperativeCOLPNCT06107595
Conditioned Open Label Placebo for Postoperative Pain Management
A study of Pain, Postoperative, run by Centre de Médecine Intégrative et Complémentaire (CEMIC) at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Jan 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Centre de Médecine Intégrative et Complémentaire, Service d'anesthésiologie, CHUV,
Lausanne, Canton of Vaud, 1011
Aurore Fernandez, 079 556 66 91, aurore.fernandez@chuv.ch
About this study
Official title: A Randomized Controlled Trial Evaluating the Efficacy of Conditioned Open Label Placebo (COLP) to Limit Opioid Reliance for Postoperative Pain Management
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).
Read the 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
- Being tested
- Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Placebo |
| Standard of care | Active comparator | Usual postoperative pain management, relying mainly on opioids Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioids consumption
Cumulative opioids intake as postoperative consumption (in MgMeq)
Measured: 17 days
Secondary outcomes (6)
Time to Opioid withdrawal (in days)
Time to Opioid withdrawal calculated for COLP compared to treatment as usual
Measured: 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)
Measured: 17 days
Satisfaction with postoperative management
Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=highest satisfaction)
Measured: 17 days
Mobility
Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=best ability to move)
Measured: 17 days
Sense of agency
Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=best sense of agency)
Measured: 17 days
Side effects intensity
Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=worst intensity)
Measured: 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start8 Jan 2024
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de Médecine Intégrative et Complémentaire (CEMIC)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chantal Berna Renella, Centre de Médecine Intégrative et Complémentaire (CEMIC)
- Investigators
- Chantal Berna Renella, Prof, Principal investigator, Centre de Médecine Intégrative et Complémentaire, Lausanne University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107595
- Sponsor's protocol ID
- 2023-01664
- Other IDs
- 2023
- Acronym
- COLP
- Status last verified
- Feb 2024
- First submitted
- 18 Oct 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Efficacy of Conditioned Open Label Placebo (COLP) to Limit Opioid Reliance for Postoperative Pain Management
- ClinicalTrials.gov ID
- NCT06107595
- Acronym / sponsor ID
- COLP / 2023-01664
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Centre de Médecine Intégrative et Complémentaire (CEMIC)University, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Efficacy of conditioned open label placebo pill | Experimental | Behavioral: PlaceboOn 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 | Behavioral: Placebo1 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 | Behavioral: PlaceboUsual postoperative pain management, relying mainly on opioids |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboParticipant take 1 dose placebo (odor or pill) on post-op day 0 (POD 0) and 3 placebo dose from POD 2 to POD 17 | Behavioural | Efficacy of conditioned open label placebo odor, Efficacy of conditioned open label placebo pill, Standard of care |
Primary outcome
Opioids consumption
Time frame: 17 days
Cumulative opioids intake as postoperative consumption (in MgMeq)
6 secondary outcomes
Time to Opioid withdrawal (in days)
Time frame: until the 6 months follow-up
Postoperative pain intensity
Time frame: 17 days
Satisfaction with postoperative management
Time frame: 17 days
Mobility
Time frame: 17 days
Sense of agency
Time frame: 17 days
Side effects intensity
Time frame: 17 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chantal Berna Renella, Prof principal investigator
Centre de Médecine Intégrative et Complémentaire, Lausanne University hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Pain, Postoperative, run by Centre de Médecine Intégrative et Complémentaire (CEMIC) at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurore Fernandez, PhD (+41 79 556 66 91, aurore.fernandez@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioids consumption (time frame: 17 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.