Lidocaine and Neuroma Pain Related Modalities

NCT02300038 | Completed

• 1 other identifier: UppsalaU
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background Subanesthetics concentrations of lidocaine are able to produce a differential block of the ectopic discharges, but not propagation of impulses, suppressing differentially the associated neuropathic pain symptoms. The aim of this study was to investigate the differences between the analgesic effects of lidocaine 0.5% and a control group of lidocaine 0.1% on several neuroma related pain modalities. Methods Sixteen patients with neuropathic pain due to painful neuromas caused by nerve injury participated in this randomized, double-blind experiment. The patterns of sensory changes were compared before and after injection of 1 ml lidocaine 0.5% and 0.1% close to the neuroma, the sessions being 1-2 weeks apart. Spontaneous and evoked pains were assessed using a visual analogue scale (VAS), quantitative and qualitative sensory testing.

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• The primary end-point measure was defined as the change in pain score measured from baseline until 60 min after injection

  60 min

Study Arms (2)

Lidocaine (Xylocaine) 0.5%

ACTIVE COMPARATOR

Injection of 1ml after mixing Lidocaine 10 mg/ml 1 ml +1 ml NaCl was administrated perineuromally

Drug: Lidocaine (Xylocaine); Dietary Supplement: NaCl

Lidocaine (Xylocaine) 10 mg/ml 0.01%

PLACEBO COMPARATOR

Injection of 1 ml from 10 mg/ml 1 ml lidocaine Xylocaine +10 ml Nacl was adminsitrated perineuromally

Drug: Lidocaine (Xylocaine); Dietary Supplement: NaCl

Interventions

Lidocaine (Xylocaine) DRUG

perineuromally administration of 1 ml lidocaine

Also known as: Xylocaine, Lidocaine

Lidocaine (Xylocaine) 0.5%; Lidocaine (Xylocaine) 10 mg/ml 0.01%

NaCl DIETARY_SUPPLEMENT

perineuromally administration of NaCL

Also known as: Sodium chloride, salt

Lidocaine (Xylocaine) 0.5%; Lidocaine (Xylocaine) 10 mg/ml 0.01%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older,
• with a history of persistent spontaneous and/or evoked pain (by e.g. touch, movement),
• who scored an average daily pain intensity of at least 4 on a 0-10 point numerical pain scale (NRS) interfering with daily activities and who had pain at least 3 months duration.
• They all had neuromas after upper extremity surgery or other trauma affecting the radial, ulnar, median or digital nerves and were eligible to participate in the study after giving written informed consent.

You may not qualify if:

• Patients with other conditions that might confound assessment of pain attributed to posttraumatic upper limb pain or
• any condition/disease that could interfere with the study measurements, such as drug abuse, diabetes, vascular disease, polyneuropathy or psychiatric diseases were excluded.

Sponsors & Collaborators

• Uppsala University: lead

MeSH Terms

Conditions

Neuralgia

Interventions

Lidocaine; Sodium Chloride; Salts

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)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, DEAA

Study Record Dates

• First Submitted: November 16, 2014
• First Posted: November 24, 2014
• Study Start: April 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2014
• Last Updated: November 24, 2014

Record last verified: 2014-11