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ACTIVE NOT RECRUITING
NCT06617065
NA

Exploring Long-term Pain Relief with 5% Dextrose Added to Local Anesthetic

Sponsor: The Seekers Centre

View on ClinicalTrials.gov

Summary

The goal of this single-arm, non-randomized, open-label trial is to determine whether adding a 5% dextrose solution to a local anesthetic can improve outcomes in patients with chronic non-cancer pain. The main question we aim to answer is whether adding a low-concentration (5%) dextrose solution to local anesthetics increases the effectiveness of trigger point injections and/or peripheral nerve blockade in the treatment of chronic non-cancer pain. Researchers will compare the outcomes of adding 5% dextrose to the usual local anesthetic solution with the outcomes of using the local anesthetic alone to determine if injection therapy is more effective when dextrose is added. Participants will: * Attend their scheduled injection treatments every two (2) weeks for a total of six (6) visits. * Complete a demographic form at the first visit, and the usual pre-visit questionnaires (the Waiting Room Form and the Brief Pain Inventory (BPI)) at every visit, as well as four (4) weeks after the sixth visit (approximately 16 weeks from the study start date). They will also need to complete two short questionnaires-the Patient Health Questionnaire (PHQ-9) and the Patient Global Impression of Change (PGIC)-at the specified intervals. * Complete all forms, which will be securely emailed to them.

Official title: A Prospective, Open-label Self-controlled Trial to Assess Long-term Changes in Pain and Function with Addition of 5% Dextrose to Local Anesthetic Solutions - the PALPADE Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2024-09-03

Completion Date

2025-02-28

Last Updated

2024-12-03

Healthy Volunteers

No

Interventions

DRUG

Addition of 1 mL of 50% dextrose solution to the usual local anesthetic solution of choice for each patient.

The principal investigator will use a palpation-guided approach to select the injection sites. Injection solutions will be prepared by the assisting nurse. For each patient, 1 mL of a 50% dextrose solution (Pfizer Canada ULS, Kirkland, Québec) will be added to the usual local anesthetic solution of choice. Solutions contain either 0.3% Ropivacaine, 1% Procaine, 0.5% Lidocaine, 0.25% Bupivacaine, or a mixture of 0.25% Bupivacaine and 2% Lidocaine in a 9:1 ratio.

Locations (1)

Seekers Centre

Ottawa, Ontario, Canada