Randomized Controlled Trial of Efficacy and Safety of Local Anesthetics and Steroids for Chronic Peripheral Post-traumatic Neuropathic Pain

NCT03009500 | Completed Phase 3

• 1 other identifier: 16-5927
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate three different injectable solutions used to block ankle nerves to manage ankle pain. The current standard of medical care is to inject a combination of local anesthetics and steroids around injured nerves. There is evidence 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. Injections of local anesthetic and steroids around injured nerves have been used for many years to provide relief of pain but the specific reason is not well known for this benefit. There are three possibilities: 1) Steroids can reduce inflammation and calm the nerves, 2) local anesthetics can have similar actions but with shorter duration (few days), and 3) injection of any solution can break scarring around an injured/compressed nerve. The study will compare pain relief and possible adverse effects from these three different solutions. This study will help provide definitive answers regarding pain relief and possible adverse effects of the three solutions. This, in turn, will determine the best possible option for injection in patients with nerve-related injury pain.

Conditions

Neuralgia; Peripheral Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Determination of Numerical Rating Scores (NRS) (range 0-10) for foot and ankle pain

  One month after intervention

Secondary Outcomes (13)

• Measuring NRS (range 0-10) for foot and ankle pain

  Three months after intervention compared to pre-intervention

• Measuring changes in the PCS (Pain Catastrophizing Scale) Questionnaire

  One month and three months after intervention compared to pre-intervention

• Measuring changes in the Douleur Neuropathique (DN4) Questionnaire

  One month and three months after intervention compared to pre-intervention

• Measuring change in the NPSI (Neuropathic Pain Symptom Inventory) Questionnaire

  One month and three months after intervention compared to pre-intervention

• Measuring change in the Anxiety and Depression component scores on the Hospital Anxiety and Depression Scale (HADS)

  One month and three months after intervention compared to pre-intervention

Study Arms (3)

Local Anesthetic

ACTIVE COMPARATOR

Injection of 2-6 cc of LA (0.25% bupivacaine) per nerve to a maximum of 20 cc

Drug: Bupivacaine; Drug: Lidocaine

Local Anesthetic with steroids

ACTIVE COMPARATOR

Injection of 2-6 cc of LA (0.25% bupivacaine) per nerve containing steroids (methylprednisolone (Depo-Medrol) 4 mg per cc) to a maximum of 20 cc

Drug: Bupivacaine; Drug: Depo-Medrol Injectable Product; Drug: Lidocaine

Saline

PLACEBO COMPARATOR

Injection of 2-6 cc of saline (0.9% sodium chloride) per nerve to a maximum of 20 cc

Other: Saline (Sodium Chloride) solution; Drug: Lidocaine

Interventions

Bupivacaine DRUG

Also known as: Marcaine

Local Anesthetic; Local Anesthetic with steroids

Depo-Medrol Injectable Product DRUG

Also known as: Methylprednisone

Local Anesthetic with steroids

Saline (Sodium Chloride) solution OTHER

Saline

Lidocaine DRUG

Each injection of study medications will be preceded by subcutaneous injections of 1 mLs of 2% lidocaine at each injection site to reduce discomfort of the study participants from the injections

Local Anesthetic; Local Anesthetic with steroids; Saline

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 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, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Bupivacaine; Sodium Chloride; Solutions; Lidocaine

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)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Pharmaceutical Preparations; Acetanilides

Study Officials

• Anuj Bhatia, MD FRCPC

  UHN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Anesthesia Chronic Pain Clinical Services

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: January 4, 2017
• Study Start: January 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: June 1, 2019
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)