Enhanced vs.Standard Pain Management of Patients at Risk for Chronic Post-surgical Pain

NCT05787691 | Unknown

• 1 other identifier: UGeneva 20221005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Post Surgical Pain

Keywords

total knee prothesis; spine surgery; thorax surgery; transitional pain service

Outcome Measures

Primary Outcomes (1)

• recruitment rate

  number of patients included in the study per month

  6 months

Secondary Outcomes (5)

• 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

Study Arms (2)

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.

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.

Interventions

Individualised pain management OTHER

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.

Also known as: Transitional Pain Service TPS

Individualised Pain Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• inability to consent and to follow the procedures of the study
• emergency surgery

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Hôpitaux Universitaires de Genève

Geneva, 1205, Switzerland

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Paulina Sypniewska El Khoury, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paulina Sypniewska El Khoury, MD

CONTACT

+41 (0) 79 55 32149; paulina.sypniewska@hcuge.ch

Benno Rehberg-Klug, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: March 28, 2023
• Study Start: May 12, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: May 17, 2023

Record last verified: 2023-05

Locations

CH (1)