Analgesic Effect of Beta 2-mimetics in the Treatment of Neuropathic Pain (Bêtapain)

University Hospital, Strasbourg, France

Status and phase: Terminated; Phase 2

Conditions: Postthoracoscopy Neuropathic Pain; Postthoracotomy Pain

Treatments: Drug: Terbutaline sustained release 5 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01582646

4705

Details and patient eligibility

About

Neuropathic pain is due to a lesion or disease affecting the nervous system. Antidepressants (ADs) are recommended as the first line treatment. In a murine model, the investigators evidenced that antidepressants antiallodynic action is mediated through β2-adrenergic receptor stimulation and that β-mimetics display the same effect. These data support the idea that β-mimetics could offer a therapeutic alternative to ADs for neuropathic pain treatment. This study will aim at assessing the effects of terbutaline on neuropathic pain symptoms.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adults from 18 to 75 years old
• neuropathic painful condition following a thoracotomy or thoracoscopy for at least 3 months

Exclusion criteria

• cardiovascular risk
• unstable diabetes mellitus
• allergy for terbutaline
• hypokaliemia without treatment
• untreated hypothyroidism
• HIV- or chemotherapy-induced neuropathy
• cancer being treated by chemo- or radio-therapy
• concomitant treatment with β-blockers, tricyclic ADs or morphine
• concomitant pain more severe than neuropathic pain- pregnant women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

first period with terbutaline and second period with placebo

Other group

Description:

The studies will be randomized, double-blind, placebo-controlled. It will use a 4 + 4 weeks crossover design for terbutaline vs. placebo (no titration). A washout period (2 weeks) will separate the treatment periods.

Treatment:

Drug: Terbutaline sustained release 5 mg

first period with placebo and second period with terbutaline.

Other group

Description:

The studies will be randomized, double-blind, placebo-controlled. It will use a 4 + 4 weeks crossover design for terbutaline vs. placebo (no titration). A washout period (2 weeks) will separate the treatment periods.

Treatment:

Drug: Terbutaline sustained release 5 mg