ALDOpilot
Enhanced vs. Standard Pain Management of Patients at Risk for Chronic Post-surgical Pain: a Randomized Controlled Pilot Trial
Sponsor study identifier
interventional
60
1 country
1
Study Start
May 12, 2023
Actual (reported)Primary Completion
September 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 7, 2023
Actual (reported)March 28, 2023
Actual (reported)May 12, 2023
Actual (reported)September 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
recruitment rate
number of patients included in the study per month
6 months
Retention rate
6 months
Data completeness rate
6 months
Number of measures accepted at 6 months
6 months
Number of measures completed at 6 months
6 months
Usefulness of a "transitional pain service" (TPS) from a patient perspective
6 months
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hôpitaux Universitaires de Genève
Geneva, 1205, Switzerland
Paulina Sypniewska El Khoury, MD
University Hospital, Geneva
Benno Rehberg-Klug, MD
CONTACT
First Submitted
February 7, 2023
First Posted
March 28, 2023
Study Start
May 12, 2023
Actual (reported)Primary Completion
September 30, 2024
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 17, 2023
Record last verified: 2023-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: