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

NCT02680548 | Completed Early Phase 1

• 1 other identifier: 15-9584-A
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

ankle pain; foot pain; methylprednisolone; neuropathic pain

Outcome Measures

Primary Outcomes (1)

• Enrollment and retention of participants (SEE DESCRIPTION)

  Factors considered in assessment: Enrolling at least 75% of eligible patients, enrolling at least 9 patients monthly, retention till study end of at least 90% of participants

  At end of study (1 year)

Secondary Outcomes (12)

• Central tendency (mean) and spread (standard deviation) of Numerical Rating Score (NRS) ratings of Foot and Ankle pain

  At 1-month and 3-months post-intervention

• Change in scores of Pain Catastrophizing Score (PCS)

  Baseline and at 1-month post-intervention

• Change in scores of Dolores Neuropathique (DN4)

  Baseline and at 1-month post-intervention

• Change in scores of Neuropathic Pain Symptom Inventory (NPSI)

  Baseline and at 1-month post-intervention

• Change in scores of anxiety component scores on the Hospital Anxiety and Depression Scale (HADS)

  Baseline and at 1-month post-intervention

Study Arms (3)

0.9% saline (salt water)

ACTIVE COMPARATOR

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

Drug: 0.9% saline

local anesthetic (freezing)

ACTIVE COMPARATOR

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

Drug: 0.25% bupivacaine hydrochloride injectable suspension USP

local anesthetic (freezing) and steroid

ACTIVE COMPARATOR

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

Drug: 0.25% bupivacaine hydrochloride injectable suspension USP; Drug: 4mg/cc methylprednisolone acetate injectable suspension USP

Interventions

0.9% saline DRUG

Also known as: Salt Water

0.9% saline (salt water)

0.25% bupivacaine hydrochloride injectable suspension USP DRUG

Also known as: Marcaine

local anesthetic (freezing); local anesthetic (freezing) and steroid

4mg/cc methylprednisolone acetate injectable suspension USP DRUG

Also known as: Depo-Medrol

local anesthetic (freezing) and steroid

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pain in foot in neuro-anatomically congruent location following trauma (including surgery) for more than three months
• Physician-reported DN4 scoring confirming neuropathic pain (score \> 3/10)
• Average intensity of pain more than 3/10 on numerical rating score
• Failed trial of appropriate doses of first line medications for neuropathic pain (anticonvulsants and/or antidepressants) for six weeks

You may not qualify if:

• Age \< 18 or age ≥ 80 years
• Perineural or intra-articular steroid injections in the last 6 months
• Allergy to local anesthetics and/or steroids
• Ongoing litigation issues related to the patient's pain
• Pregnancy
• Coagulopathy or systemic infection
• Peripheral neuropathy or myopathy, central neuropathic pain (e.g. post-stroke pain)
• Infection in the ankle or foot
• An unstable medical or psychiatric condition
• Significant catastrophizing as indicated by pain catastrophizing scale (PCS) score equal to or more than 30/52

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

Location

Related Publications (1)

• 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.

  PMID: 27334885 DERIVED

MeSH Terms

Conditions

Neuralgia

Interventions

Saline Solution; Fluoridation; Bupivacaine; Methylprednisolone Acetate

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Preventive Dentistry; Dentistry; Public Health Dentistry; Environment and Public Health; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Anuj Bhatia, MD, FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: February 11, 2016
• Study Start: November 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 3, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)