Overview

This trial is active, not recruiting.

Condition chronic post-traumatic neuropathic pain in ankle and foot
Treatments 0.9% saline, 0.25% bupivacaine hydrochloride injectable suspension usp, 4mg/cc methylprednisolone acetate injectable suspension usp
Phase phase 0
Sponsor University Health Network, Toronto
Start date November 2015
End date November 2016
Trial size 30 participants
Trial identifier NCT02680548, 15-9584-A

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
0.5mL 0.25% bupivacaine subcutaneous injection, 2-6cc 0.9% saline injection per nerve (20cc max)
0.9% saline Salt Water
(Active Comparator)
0.5mL 0.25% bupivacaine subcutaneous injection, 2-6cc 0.25% bupivacaine per nerve (20cc max)
0.25% bupivacaine hydrochloride injectable suspension usp Marcaine
(Active Comparator)
0.5mL 0.25% bupivacaine subcutaneous injection, 2-6cc 0.25% bupivacaine and 4mg/cc methylprednisolone per nerve (20cc max)
0.25% bupivacaine hydrochloride injectable suspension usp Marcaine
4mg/cc methylprednisolone acetate injectable suspension usp Depo-Medrol

Primary Outcomes

Measure
Enrollment and retention of participants (SEE DESCRIPTION)
time frame: At end of study (1 year)

Secondary Outcomes

Measure
Central tendency (mean) and spread (standard deviation) of Numerical Rating Score (NRS) ratings of Foot and Ankle pain
time frame: At 1-month and 3-months post-intervention
Change in scores of Pain Catastrophizing Score (PCS)
time frame: Baseline and at 1-month post-intervention
Change in scores of Dolores Neuropathique (DN4)
time frame: Baseline and at 1-month post-intervention
Change in scores of Neuropathic Pain Symptom Inventory (NPSI)
time frame: Baseline and at 1-month post-intervention
Change in scores of anxiety component scores on the Hospital Anxiety and Depression Scale (HADS)
time frame: Baseline and at 1-month post-intervention
Change in scores of depression scores on the Patient Health Questionnaire-9 (PHQ-9)
time frame: Baseline and at 1-month post-intervention
Change in scores of Brief Pain Inventory interference with activities (BPI-I)
time frame: Baseline and at 1-month post-intervention
Change in scores of Short Form-12 (SF-12)
time frame: Baseline and at 1-month post-intervention
Change in scores of Lower Extremity Function Score (LEFS)
time frame: Baseline and at 1-month post-intervention
Evaluate the impact of study interventions on requirement for opioids (measured as average daily oral morphine equivalents in mg) and neuropathic medications (average daily doses of gabapentin and/or amitriptyline in mg)
time frame: At end of study (1 year)
Change in pre- and post-intervention levels of blood glucose and blood pressure
time frame: Baseline and at 1-month post-intervention
Measure incidence of infections at the injection site, skin discoloration or atrophy at the injection site, fractures, and evidence of myopathy
time frame: Baseline and at 1-month post-intervention

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title A Pilot Randomized Controlled Trial of Efficacy of Perineural Local Anesthetics and Steroids for Chronic Post-traumatic Neuropathic Pain in the Ankle and the Foot: The PREPLAN Study
Principal investigator Anuj Bhatia, MD, FRCPC
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.