Dextrose-Enhanced Anesthetic for Chronic Pain

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Seekers Centre

Disqualifiers: Pregnancy, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

70 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals with chronic non-cancer pain who regularly receive trigger point injections or peripheral nerve blockade. Participants must be able to attend treatment every two weeks for three months and complete several questionnaires about their health and pain levels.

Inclusion Criteria

I have been experiencing chronic pain for at least 3 months.

I have been on injection therapy every 1-3 weeks for at least 6 months.

English proficiency

Exclusion Criteria

I am under 18 years old.

Pregnancy

Lack of English proficiency or unable to complete patient forms

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injection treatments with 5% dextrose added to local anesthetics every two weeks for a total of six visits

12 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including PHQ-9, VAS, PGIC, and BPI

4 weeks

1 visit (virtual)

Treatment Details

Interventions

• Addition of 5% Dextrose to Local Anesthetic

Trial Overview The study is testing if adding a small amount (5%) of dextrose to the usual local anesthetic improves long-term pain relief in patients. It's a single-arm, open-label trial where everyone gets the same intervention without being compared to a control group.

Participant Groups

Group I: Addition of 1 mL of 50% dextrose solution to the usual local anesthetic solution of choice Experimental Treatment 1 Intervention

The physician will add 1 mL of 50% dextrose solution (Pfizer Canada ULS, Kirkland, Québec) to the usual local anesthetic solution of choice for each patient. 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.

Who Is Running the Clinical Trial?

The Seekers Centre

Lead Sponsor

Trials

1

Recruited

70+