Chronic Post Surgical PainALDOpilotNCT05787691
Enhanced vs.Standard Pain Management of Patients at Risk for Chronic Post-surgical Pain
A study testing Individualised pain management in people with Chronic Post Surgical Pain, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The goal of this pragmatic pilot clinical trial is to test the feasibility of the trial in terms of the number of patients recruited in a given period. The main question it aims to answer is to assess the number of eligible patients and number of patients willing to participate per month. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Post Surgical Pain
- What is being tested?
- Individualised pain management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 May 2023to 30 Sep 2024
- 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
- patients scheduled for spine surgery or total knee replacement surgery or thoracic surgery
- patients of 18 years or more
- ability to speak and read French
Who cannot join
- inability to consent and to follow the procedures of the study
- emergency surgery
Trial locations and contacts
1 site in 1 country.
Benno Rehberg-Klug, MD contact
Switzerland1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Genève
Geneva, 1205
Paulina Sypniewska, MD, paulina.sypniewska@hcuge.ch
Benno Rehberg-Klug, MD, breh@hcuge.ch
About this study
Official title: Enhanced vs. Standard Pain Management of Patients at Risk for Chronic Post-surgical Pain: a Randomized Controlled Pilot Trial
The goal of this pragmatic pilot clinical trial is to test the feasibility of the trial in terms of the number of patients recruited in a given period.
The main question it aims to answer is to assess the number of eligible patients and number of patients willing to participate per month.
Read more
Participants will be followed either by the team of "transitional pain service" (intervention group) or by a surgeon or the general practitioner (standard care). Depending on individual risk factors, patients in the intervention group will be offered some targeted measures, for example:
- hypnosis,
- patient education,
- evaluation by psychiatrist,
- psychotherapy,
- locoregional anesthesia,
- anti-depressant treatment Participants (in both intervention and standard care groups) will be asked to answer some questions before surgery, during the first week following the surgery and six months after the surgery.
Read the detailed description
Moderate to severe persistent post-surgery pain occurs in up to 12% of patients at 6 months post-surgery according to the large European study cohort. Our own data from a previous study at the University Hospitals of Geneva (HUG) (unpublished, alerte douleur-ALDO study) showed a prevalence of chronic post-surgical pain (CPSP) 6 months after selected types of surgery of 30.9%. Strategies to detect and prevent CPSP have not been applied systematically in clinical practice until now, despite routine surgical follow-up visits after surgery.
There are only few hospitals who have implemented a "transitional pain service (TPS)" to diminish the risk of the transition of acute to chronic pain after surgery, and the Anesthesia Department of the University Hospitals of Geneva is currently experimenting with such a team. A future study needs to validate the effectiveness of this approach.
The present study is planned as a pilot trial to test the feasibility, usability, acceptance, and to provide the parameters necessary to design this future study validating or refuting the utility of individually targeted combinations of preventive measures implemented by a "transitional pain service" in reducing the incidence of chronic pain 6 months after surgery.
The primary objective is to evaluate the feasibility of the trial in terms of the number of patients recruited in a given period.
Secondary objectives are:
- To determine patient acceptance of the proposed interventions and thus the percentage of patients receiving the planned interventions in reality in the treatment group
- To determine the percentage of patients in the control group receiving the treatments proposed in the intervention group by other caregivers outside of the study (patients in the control group may even receive such treatment by the investigators if requested by the patients or another physician)
- To evaluate the usefulness of a transitional pain service (TPS) from a patient perspective
- To determine the optimal primary outcome measure of the definitive trial
The study is a single-center, randomized controlled clinical pilot trial, designed to estimate the parameters necessary for planning a definitive, potentially multicentric study.
The randomization will follow 1: 1 allocation, with 2 parallel groups of patients with increased risk for CPSP (intervention group vs. a group with a routine follow up). A total of 60 patients will be included.
Patients undergoing spinal surgery, total knee replacement surgery or thoracic surgery will be screened for inclusion in the study.
Patients will be contacted for an informed consent, either by telephone and email, or by a personal visit before the surgery.
Following informed consent, all patients included will receive a set of questionnaires (by email or in paper form) concerning psychological risk factors and details about preexisting chronic pain.
Consenting patients will be randomized using a computer-generated list to either the treatment or the control group.
In neither group, surgical management of included patients will be influenced by the study.
In the intervention group, patients will be followed by the team of the "transitional pain service" of the University Hospitals of Geneva, and depending on individual risk factors, contraindications and following discussion with the patient (shared decision-making) the bundle of individually targeted measures.
In the control group, no specific measures will be applied, and patients are followed by their surgeon and general practitioner. In addition, during the hospitalization the Acute Pain Team may be requested. In case of persistent pain, it may happen that the surgeon or the general practitioner refers a patient to a chronic pain specialist. This will not lead to the exclusion of the patient.
Patients of both groups will receive identical follow-up questionnaires after surgery and outcome questionnaires by electronic or written form at 6 months after surgery.
- Conditions
- Chronic Post Surgical Pain
- Being tested
- Individualised pain management
- Keywords
- total knee prothesis, spine surgery, thorax surgery, transitional pain service
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualised pain managementOther
Also called Transitional Pain Service TPS
TPS pain management consists in an evaluation by a pain physician, followed by specific measures for patients identified as having a particularly high risk of CPSP. The choice of these measures will be individualised according to specific risk factors and left to the discretion of the pain physician.
Potential measures: patient education, adjustment of analgesic therapy, referral to a psychiatrist or psychologist, cognitive behavioural therapy, hypnosis, use of locoregional analgesia for surgery, infusions of ketamine and/or lidocaine, introduction of gabapentins and/or antidepressants.
| Study group | Role | What they receive |
|---|---|---|
| Individualised Pain Management | Experimental | In the intervention group, patients will be followed by the team of the "transitional pain service" of the HUG, and depending on individual risk factors, contraindications and following discussion with the patient (shared decision-making) the bundle of individually targeted measures will be applied. Receives: Other: Individualised pain management |
| Standard care | No intervention | In the control group, no specific measures will be applied, and patients are followed by their surgeon and general practitioner. In addition, during the hospitalization the Acute Pain Team may be requested. In case of persistent pain, it may happen that the surgeon or the general practitioner refers a patient to a chronic pain specialist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
recruitment rate
number of patients included in the study per month
Measured: 6 months
Secondary outcomes (5)
Retention rate
number of patients who complete the study
Measured: 6 months
Data completeness rate
number of patients with complete data sets
Measured: 6 months
Number of measures accepted at 6 months
Number of patients who accepted each preventive measure in the intervention and control groups
Measured: 6 months
Number of measures completed at 6 months
Number of patients who completed each preventive measure in the intervention and control groups
Measured: 6 months
Usefulness of a "transitional pain service" (TPS) from a patient perspective
number of patients evaluating the preventive treatment useful or non-useful at 6 months post-surgery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start12 May 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Post Surgical PainStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paulina Sypniewska El Khoury, MD, University Hospital, Geneva
- Investigators
- Paulina Sypniewska El Khoury, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787691
- Sponsor's protocol ID
- UGeneva 20221005
- Acronym
- ALDOpilot
- Status last verified
- May 2023
- First submitted
- 7 Feb 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced vs. Standard Pain Management of Patients at Risk for Chronic Post-surgical Pain: a Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT05787691
- Acronym / sponsor ID
- ALDOpilot / UGeneva 20221005
- Conditions
- Chronic Post Surgical Pain
- Keywords
- total knee prothesis, spine surgery, thorax surgery, transitional pain service
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 28 Mar 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 goal of this pragmatic pilot clinical trial is to test the feasibility of the trial in terms of the number of patients recruited in a given period.
The main question it aims to answer is to assess the number of eligible patients and number of patients willing to participate per month.
Participants will be followed either by the team of "transitional pain service" (intervention group) or by a surgeon or the general practitioner (standard care). Depending on individual risk factors, patients in the intervention group will be offered some targeted measures, for example:
- hypnosis,
- patient education,
- evaluation by psychiatrist,
- psychotherapy,
- locoregional anesthesia,
- anti-depressant treatment Participants (in both intervention and standard care groups) will be asked to answer some questions before surgery, during the first week following the surgery and six months after the surgery.
Detailed description
Moderate to severe persistent post-surgery pain occurs in up to 12% of patients at 6 months post-surgery according to the large European study cohort. Our own data from a previous study at the University Hospitals of Geneva (HUG) (unpublished, alerte douleur-ALDO study) showed a prevalence of chronic post-surgical pain (CPSP) 6 months after selected types of surgery of 30.9%. Strategies to detect and prevent CPSP have not been applied systematically in clinical practice until now, despite routine surgical follow-up visits after surgery.
There are only few hospitals who have implemented a "transitional pain service (TPS)" to diminish the risk of the transition of acute to chronic pain after surgery, and the Anesthesia Department of the University Hospitals of Geneva is currently experimenting with such a team. A future study needs to validate the effectiveness of this approach.
The present study is planned as a pilot trial to test the feasibility, usability, acceptance, and to provide the parameters necessary to design this future study validating or refuting the utility of individually targeted combinations of preventive measures implemented by a "transitional pain service" in reducing the incidence of chronic pain 6 months after surgery.
The primary objective is to evaluate the feasibility of the trial in terms of the number of patients recruited in a given period.
Secondary objectives are:
- To determine patient acceptance of the proposed interventions and thus the percentage of patients receiving the planned interventions in reality in the treatment group
- To determine the percentage of patients in the control group receiving the treatments proposed in the intervention group by other caregivers outside of the study (patients in the control group may even receive such treatment by the investigators if requested by the patients or another physician)
- To evaluate the usefulness of a transitional pain service (TPS) from a patient perspective
- To determine the optimal primary outcome measure of the definitive trial
The study is a single-center, randomized controlled clinical pilot trial, designed to estimate the parameters necessary for planning a definitive, potentially multicentric study.
The randomization will follow 1: 1 allocation, with 2 parallel groups of patients with increased risk for CPSP (intervention group vs. a group with a routine follow up). A total of 60 patients will be included.
Patients undergoing spinal surgery, total knee replacement surgery or thoracic surgery will be screened for inclusion in the study.
Patients will be contacted for an informed consent, either by telephone and email, or by a personal visit before the surgery.
Following informed consent, all patients included will receive a set of questionnaires (by email or in paper form) concerning psychological risk factors and details about preexisting chronic pain.
Consenting patients will be randomized using a computer-generated list to either the treatment or the control group.
In neither group, surgical management of included patients will be influenced by the study.
In the intervention group, patients will be followed by the team of the "transitional pain service" of the University Hospitals of Geneva, and depending on individual risk factors, contraindications and following discussion with the patient (shared decision-making) the bundle of individually targeted measures.
In the control group, no specific measures will be applied, and patients are followed by their surgeon and general practitioner. In addition, during the hospitalization the Acute Pain Team may be requested. In case of persistent pain, it may happen that the surgeon or the general practitioner refers a patient to a chronic pain specialist. This will not lead to the exclusion of the patient.
Patients of both groups will receive identical follow-up questionnaires after surgery and outcome questionnaires by electronic or written form at 6 months after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualised Pain Management | Experimental | Other: Individualised pain managementIn the intervention group, patients will be followed by the team of the "transitional pain service" of the HUG, and depending on individual risk factors, contraindications and following discussion with the patient (shared decision-making) the bundle of individually targeted measures will be applied. |
| Standard care | No intervention | –In the control group, no specific measures will be applied, and patients are followed by their surgeon and general practitioner. In addition, during the hospitalization the Acute Pain Team may be requested. In case of persistent pain, it may happen that the surgeon or the general practitioner refers a patient to a chronic pain specialist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients scheduled for spine surgery or total knee replacement surgery or thoracic surgery
- patients of 18 years or more
- ability to speak and read French
Key exclusion criteria (2 listed)
- inability to consent and to follow the procedures of the study
- emergency surgery
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 |
|---|---|---|
| Individualised pain managementAlso: Transitional Pain Service TPSTPS pain management consists in an evaluation by a pain physician, followed by specific measures for patients identified as having a particularly high risk of CPSP. The choice of these measures will be individualised according to specific risk factors and left to the discretion of the pain physician. Potential measures: patient education, adjustment of analgesic therapy, referral to a psychiatrist or psychologist, cognitive behavioural therapy, hypnosis, use of locoregional analgesia for surgery, infusions of ketamine and/or lidocaine, introduction of gabapentins and/or antidepressants. | Other | Individualised Pain Management |
Primary outcome
recruitment rate
Time frame: 6 months
number of patients included in the study per month
5 secondary outcomes
Retention rate
Time frame: 6 months
Data completeness rate
Time frame: 6 months
Number of measures accepted at 6 months
Time frame: 6 months
Number of measures completed at 6 months
Time frame: 6 months
Usefulness of a "transitional pain service" (TPS) from a patient perspective
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
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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.
Benno Rehberg-Klug, MD contact
Paulina Sypniewska El Khoury, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualised pain management in people with Chronic Post Surgical Pain, run by University Hospital, Geneva 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 3 inclusion and 2 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 17 May 2023. 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 Paulina Sypniewska El Khoury, MD (+41 (0) 79 55 32149, paulina.sypniewska@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recruitment rate (time frame: 6 months). 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 17 May 2023.