Preoperative Gabapentin for Chronic Pain After Thoracotomy (GABATHOMIE).

University Hospital, Lille

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain; Chronic Pain

Treatments: Drug: Placebo; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT03158376

2014_12

2014-005226-35 (EudraCT Number)

Details and patient eligibility

About

To assess the effects of prolonged preoperative gabapentin treatment (10 days) on chronic pain after thoracotomy.

Full description

Randomized, double blind study enrolling 200 adults undergoing thoracotomy. Patients receive either 75 mg hydroxyzine before surgery and placebo 3 times daily for 10 days or 1200 mg gabapentin before surgery continued for 10 days. All patients receive also a thoracic epidural analgesia.

Assessment of chronic pain at 3 month with an evaluation by a physician (pain intensity, pain quality and analgesia requirement).

Assessment of acute pain in the early postoperative period (pain intensity, pain quality and analgesia requirement).

Enrollment: 201 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age > 18 years
• elective lung resection via thoracotomy

Exclusion criteria

• extended pleurectomy and chest wall resection
• previous ipsilateral thoracotomy
• previous ipsilateral radiotherapy
• thoracotomy for pyothorax
• chest injury
• palliative surgery
• contraindicated placement of a thoracic epidural catheter
• allergy to medications on protocol
• pre-existing pain syndrome
• current treatment with morphine, gabapentin, pregabalin, anticonvulsivants or tricyclic antidepressants
• a history of past or current drug addiction
• severe hepatic, renal or cardiovascular disorders
• inability to understand the study protocol or to answer the questionnaires on pain and quality of life
• severe psychiatric disorders
• incompetent adults under some form of guardianship
• refusal of the protocol
• persons without social security coverage
• pregnant or lactating woman

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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201 participants in 2 patient groups, including a placebo group

gabapentin group

Experimental group

Description:

* the day before surgery : gabapentin 400 mg orally * preoperatively (2 hours before surgery) : 3 capsules each containing 400 mg gabapentin (total gabapentin dose 1200 mg) and intravenous infusion of 50 ml of normal saline solution * postoperative day 1 to 10 : 400 mg x 3 ( gabapentin 1200 mg daily)

Treatment:

Drug: Gabapentin

placebo group

Placebo Comparator group

Description:

* The day before surgery: 1 placebo capsule orally * preoperatively (2 hours before surgery) : 3 placebo capsules and intravenous infusion of 75 mg hydroxyzine * postoperative day 1 to 10: 1 placebo capsule x 3

Treatment:

Drug: Placebo