Early Administration of Botox® in Neuropathic Pain Due to Thoracoscopy or Thoracotomy

NCT01325090 | Withdrawn Phase 3

• 2 other identifiers: I09006 / APTODON2010-021506-38
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Botulinum toxin type A has been reported to inhibit the release of various pain neurotransmitters (SP, CGRP, glutamate) responsible for neurogenic inflammation, a process that results from the sensitization of C-fiber nociceptors (peripheral sensitization). This action is probably responsible for the analgesic effect of botulinum toxin type A recently demonstrated in patients with neuropathic pain of peripheral origin.In those studies, patients had been suffering for years. The investigators can hypothesizes that earlier administration of Botox in the course of neuropathic pain might prevent central sensitization, that is secondary to peripheral sensitization. The investigators can hope to increase efficacy of Botulinum toxin type A injections and to prevent chronification of pain.

Conditions

Pain Due to Certain Specified Procedures; Neuropathic Pain

Keywords

neuropathic pain due to thoracotomy; Neuropathic Pain Due to Thoracoscopy

Outcome Measures

Primary Outcomes (1)

• decrease in average pain intensity as measured by the Brief Pain Inventory (BPI)

  one month

Secondary Outcomes (2)

• VAS in the last 24 hours

  24 hours

• Neuropathic Pain Inventory

  6 months

Study Arms (2)

BOTOX

EXPERIMENTAL

Patients will receive in one session multiple intradermal injections of Botox, in order to cover the whole painful area

Drug: BOTOX

PLACEBO

PLACEBO COMPARATOR

Patients will receive in one session multiple intradermal injections of placebo , in order to cover the whole painful area

Other: PLACEBO

Interventions

BOTOX DRUG

A syringe of 1 ml contain 25 Allergan units.

BOTOX

PLACEBO OTHER

The pharmacist will fill syringes in tuberculins of 1 ml with injectable solution of sodium chloride of 0,9 %.

PLACEBO

Eligibility Criteria

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

You may qualify if:

• daily pain, for 3 months, secondary to thoracoscopy or thoracotomy, of neuropathic origin (DN4 questionary)

You may not qualify if:

• contraindications for botulinum toxin

Sponsors & Collaborators

• University Hospital, Limoges: lead

MeSH Terms

Conditions

Neuralgia

Interventions

Botulinum Toxins, Type A

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)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Danièle RANOUX, MD

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: March 29, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2014
• Last Updated: August 13, 2018

Record last verified: 2011-03