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

University of Limoges (UL)

Status and phase: Withdrawn; Phase 3

Conditions: Pain Due to Certain Specified Procedures; Neuropathic Pain

Treatments: Drug: BOTOX; Other: PLACEBO

Study type: Interventional

Funder types: Other

Identifiers

NCT01325090

I09006 / APTODON

2010-021506-38 (EudraCT Number)

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• contraindications for botulinum toxin

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

0 participants in 2 patient groups, including a placebo group

BOTOX

Experimental group

Description:

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

Treatment:

Drug: BOTOX

PLACEBO

Placebo Comparator group

Description:

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

Treatment:

Other: PLACEBO