Preoperative Gabapentin for Chronic Pain After Thoracotomy (GABATHOMIE).

NCT ID: NCT03158376

Last Updated: 2022-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2019-05-24

Brief Summary

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

Detailed 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).

Conditions

Postoperative Pain; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

gabapentin group

• 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)

Group Type: EXPERIMENTAL

Gabapentin

Intervention Type: DRUG

placebo group

• 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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Gabapentin

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

gabapentin Biogaran 400 mg capsule; placebo oral capsule (lactose)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lille Nord de France

OTHER

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques Desbordes, MD

Role: PRINCIPAL_INVESTIGATOR

Lille University Hospital

Locations

Department of Thoracic Surgery, Lille University Hospital

Lille, , France

Countries

France

Other Identifiers

2014-005226-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2014_12

Identifier Type: -

Identifier Source: org_study_id