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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding a small amount of sugar water (5% dextrose) to pain-numbing injections can better assist individuals with long-term, non-cancer pain. Researchers aim to determine if this sugar-enhanced solution increases the effectiveness of the injections compared to regular pain-numbing shots alone. Ideal participants have experienced chronic pain for at least three months and have been receiving injection treatments every 1-3 weeks for the past six months. As an unphased trial, this study provides a unique opportunity to contribute to innovative pain management research.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that adding 5% dextrose to local anesthetics is safe for treating chronic pain?

Research has shown that adding dextrose to local anesthetics is generally safe for pain relief. In studies, patients who received 5% dextrose with local anesthetics reported less pain and did not experience major side effects, indicating the treatment is usually well-tolerated. Dextrose is also used in other medical treatments, such as prolotherapy, to help reduce pain and improve joint movement.

Although specific safety data for the exact mix of dextrose and anesthetics in this trial is not available, existing research on dextrose in similar situations has demonstrated its safety for people. Based on these findings, adding dextrose to local anesthetics for long-term pain is likely safe. Participants should always discuss possible risks with their healthcare providers before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard local anesthetics for chronic pain, which simply block nerve signals, the addition of a small amount of dextrose to these anesthetics may offer enhanced pain relief. Researchers are excited about this treatment because dextrose, a type of sugar, could potentially amplify the effects of existing anesthetics like Ropivacaine or Lidocaine. This might mean longer-lasting pain relief or a reduction in pain intensity, offering a new approach to managing chronic pain more effectively. By enhancing anesthetic potency with dextrose, patients might experience quicker and possibly more sustained relief, which is a promising development in pain management.

What evidence suggests that adding 5% dextrose to local anesthetics might be an effective treatment for chronic pain?

Research has shown that adding a 5% sugar-water solution to local painkillers may help relieve long-term pain. In this trial, participants will receive an experimental treatment where 1 mL of 50% dextrose solution is added to their usual local anesthetic solution. One study found that 84% of patients who received sugar-water experienced no knee pain after a year, compared to 46% of those who received regular painkillers. Sugar-water injections, similar to prolotherapy, have safely reduced ongoing muscle and joint pain. Studies suggest that sugar-water can also improve movement and help heal tissues, which might explain its pain-relieving effects. Overall, early findings are promising for using sugar-water to enhance pain treatments. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5554430/

Short Term Analgesic Effects of 5% Dextrose Epidural ... Dextrose injection (prolotherapy) is reported to safely reduce chronic musculoskeletal pain and improve function in a variety of conditions, though the ...

2. trial.medpath.com trial.medpath.com/clinical-trial/ce5356241bd66838/prospective-open-label-trial-dextrose-anesthetic-pain-function

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

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4938120/

A Systematic Review of Dextrose Prolotherapy for Chronic ... At one year, 84% of the dextrose-treated knees were pain free compared to 46% of the lidocaine-treated knees. Temporal mandibular joint syndrome. Few studies ...

4. now.aapmr.org now.aapmr.org/therapeutic-injection-of-dextrose-prolotherapy-perineural-injection-therapy-and-hydrodissection/

Therapeutic Injection of Dextrose: Prolotherapy, Perineural ... Basic science and clinical research suggest several ways in which dextrose can reduce pain, improve overall function, and restore connective tissue function.

5. epain.org epain.org/journal/view.html?doi=10.3344/kjp.2021.34.1.19

The proper concentrations of dextrose and lidocaine in ... Results: The cell viability was decreased in concentrations of more than 5% dextrose and 0.1% lidocaine. However, in the concentrations 1% ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07052721

Randomized Study of an Analgesic Device Enabling Local ... Intraoperatively, surgeons will be permitted to infiltrate the surgical area with long-acting local anesthetic as their common practice dictates.

7. hsrd.research.va.gov hsrd.research.va.gov/publications/esp/dextrose-prolotherapy-report.pdf

Dextrose Prolotherapy for Musculoskeletal Pain when comparing outcomes for 5%, 10%, and 20% dextrose injections. At 6 weeks follow-up, 10% and. 20% dextrose arms had lower WOMAC scores (mean 33.7 and 34.4 ...