Pilot RCT of Efficacy of Perineural Local Anesthetics and Steroids for Chronic Post-traumatic Ankle and Foot Pain

NCT ID: NCT02680548

Last Updated: 2018-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-12-31

Brief Summary

Injections of local anesthetics (freezing) and steroids are often performed around injured nerves in individuals with nerve injury-related pain. The current standard of medical care is to inject a combination of local anesthetics and steroids around injured nerves, but there is no proof that this is better than injecting only local anesthetic, or even just sterile salt water. There is evidence to believe that injection of local anesthetic (without the steroid) can calm the injured nerve, and provide pain relief from a few days up to a few months. Injection of sterile salt water also has the potential to provide pain relief by breaking scar tissue around the nerve, thereby relieving compression. The aim of this study is to compare pain relief and possible adverse effects from these three different treatments for foot and ankle nerve pain relief.

All 30 participants will be recruited over 9 months from the Altum Health clinic at Toronto Western Hospital. 10 participants will be randomly assigned to each treatment. Each patient will receive 3 injections over 3 weeks or so. Participants will have an in-clinic follow-up at 1 month after the last injection, and a phone follow-up 3 months after the last injection.

This is a small-scale study, and information obtained from this study will help in planning and conduct of a larger study with more participants. The larger study will help determine the best possible option for injection in patients with nerve-related injury pain.

Conditions

CHRONIC POST-TRAUMATIC NEUROPATHIC PAIN IN ANKLE AND FOOT

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

0.9% saline (salt water)

0.5mL 0.25% bupivacaine subcutaneous injection, 2-6cc 0.9% saline injection per nerve (20cc max)

Group Type: ACTIVE_COMPARATOR

0.9% saline

Intervention Type: DRUG

local anesthetic (freezing)

0.5mL 0.25% bupivacaine subcutaneous injection, 2-6cc 0.25% bupivacaine per nerve (20cc max)

Group Type: ACTIVE_COMPARATOR

0.25% bupivacaine hydrochloride injectable suspension USP

Intervention Type: DRUG

local anesthetic (freezing) and steroid

0.5mL 0.25% bupivacaine subcutaneous injection, 2-6cc 0.25% bupivacaine and 4mg/cc methylprednisolone per nerve (20cc max)

Group Type: ACTIVE_COMPARATOR

0.25% bupivacaine hydrochloride injectable suspension USP

Intervention Type: DRUG

4mg/cc methylprednisolone acetate injectable suspension USP

Intervention Type: DRUG

Interventions

0.9% saline

Intervention Type: DRUG

0.25% bupivacaine hydrochloride injectable suspension USP

Intervention Type: DRUG

4mg/cc methylprednisolone acetate injectable suspension USP

Intervention Type: DRUG

Other Intervention Names

Salt Water; Marcaine; Depo-Medrol

Eligibility Criteria

Inclusion Criteria

1. Pain in foot in neuro-anatomically congruent location following trauma (including surgery) for more than three months

2. Physician-reported DN4 scoring confirming neuropathic pain (score > 3/10)

3. Average intensity of pain more than 3/10 on numerical rating score

4. Failed trial of appropriate doses of first line medications for neuropathic pain (anticonvulsants and/or antidepressants) for six weeks

Exclusion Criteria

1. Age < 18 or age ≥ 80 years

2. Perineural or intra-articular steroid injections in the last 6 months

3. Allergy to local anesthetics and/or steroids

4. Ongoing litigation issues related to the patient's pain

5. Pregnancy

6. Coagulopathy or systemic infection

7. Peripheral neuropathy or myopathy, central neuropathic pain (e.g. post-stroke pain)

8. Infection in the ankle or foot

9. An unstable medical or psychiatric condition

10. Significant catastrophizing as indicated by pain catastrophizing scale (PCS) score equal to or more than 30/52

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Anuj Bhatia

Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anuj Bhatia, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Toronto Western Hospital

Toronto, Ontario, Canada

Countries

Canada

References

Bhatia A, Bril V, Brull RT, Perruccio A, Wijeysundera D, Alvi S, Lau J, Gandhi R, Mahomed N, Davis AM. Study protocol for a pilot, randomised, double-blinded, placebo controlled trial of perineural local anaesthetics and steroids for chronic post-traumatic neuropathic pain in the ankle and foot: the PREPLANS study. BMJ Open. 2016 Jun 22;6(6):e012293. doi: 10.1136/bmjopen-2016-012293.

Reference Type: DERIVED

PMID: 27334885 (View on PubMed)

Other Identifiers

15-9584-A

Identifier Type: -

Identifier Source: org_study_id