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

NCT06617065 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-12-03

No results posted yet for this study

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.

Conditions

  • Chronic Non-cancer Pain

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.

Sponsors & Collaborators

  • The Seekers Centre

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-03
Primary Completion
2025-01-30
Completion
2025-02-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06617065 on ClinicalTrials.gov