Preoperative Gabapentin for Chronic Pain After Thoracotomy (GABATHOMIE).

NCT03158376 | Completed Phase 3 DMC

• 2 other identifiers: 2014_122014-005226-35
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Pain; Chronic Pain

Keywords

gabapentin; thoracotomy; chronic post-thoracotomy pain; acute post-thoracotomy pain; quality of life; neuropathic pain

Outcome Measures

Primary Outcomes (1)

• Persistent chronic post-thoracotomy pain

  Pain intensity is measured on a 11-point numeric pain rating scale ; a score \>=0 is considered as chronic pain.

  3 months after surgery

Secondary Outcomes (10)

• Quantitative pain assessment: Acute postoperative pain intensity

  Within the first 10 postoperative days

• Quantitative pain assessment: Rescue analgesics requirement

  Within the first 3 months after surgery

• Quantitative pain assessment: volume of epidural infusion

  Within the 5 postoperative days

• Qualitative pain assessment: incidence of neuropathic pain

  postoperative day 2

• Qualitative pain assessment: incidence of neuropathic pain

  postoperative day 6

Study Arms (2)

gabapentin group

EXPERIMENTAL

* 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)

Drug: Gabapentin

placebo group

PLACEBO COMPARATOR

* 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

Drug: Placebo

Interventions

Gabapentin DRUG

Also known as: gabapentin Biogaran 400 mg capsule

gabapentin group

Placebo DRUG

Also known as: placebo oral capsule (lactose)

placebo group

Eligibility Criteria

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

You may qualify if:

• age \> 18 years
• elective lung resection via thoracotomy

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• University of Lille Nord de France: collaborator

Study Sites (1)

Department of Thoracic Surgery, Lille University Hospital

Lille, 59000, France

Location

MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain; Neuralgia

Interventions

Gabapentin; Lactose

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Jacques Desbordes, MD

  Lille University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 18, 2017
• Study Start: September 1, 2015
• Primary Completion: May 24, 2019
• Study Completion: May 24, 2019
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)