Preoperative Gabapentin for Chronic Pain After Thoracotomy (GABATHOMIE). (GABATHOMIE)

Perioperative Gabapentin for Chronic Post-thoracotomy Pain: a Randomized, Double Blind, Placebo-controlled Study.

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

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Postoperative Pain
• Intervention / Treatment: Drug: Placebo; Drug: Gabapentin

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).

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Lille, France, 59000
    • Department of Thoracic Surgery, Lille University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: Gabapentin; Other Names: gabapentin Biogaran 400 mg capsule
Placebo Comparator: 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	Drug: Placebo; Other Names: placebo oral capsule (lactose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative pain assessment: Acute postoperative pain intensity	Measured on a 11-point numeric rating scale	Within the first 10 postoperative days
Quantitative pain assessment: Rescue analgesics requirement	consumption of additional analgesics (opioids, nefopam or non steroidal anti-inflammatory drug) and time to first request.	Within the first 3 months after surgery
Quantitative pain assessment: volume of epidural infusion	total dose of epidural local anesthetic and epidural morphine	Within the 5 postoperative days
Qualitative pain assessment: incidence of neuropathic pain	Assessed by DN4 (Neuropathic pain 4), NPSI (Neuropathic Pain Symptom Inventory) and QDSA ( Saint Antoine French questionnaire = McGill questionnaire)	postoperative day 2
Qualitative pain assessment: incidence of neuropathic pain	Assessed by DN4 (Neuropathic pain 4), NPSI (Neuropathic Pain Symptom Inventory) and QDSA ( Saint Antoine French questionnaire = McGill questionnaire)	postoperative day 6
Qualitative pain assessment: incidence of neuropathic pain	Assessed by DN4 (Neuropathic pain 4), NPSI (Neuropathic Pain Symptom Inventory) and QDSA ( Saint Antoine French questionnaire = McGill questionnaire)	3 months after surgery
Qualitative pain assessment: Rescue analgesics requirement for neuropathic pain	Time to first request and consumption (doses and length of treatment) of gapapentinoids, amitriptyline	within the first 3 months after surgery
Qualitative pain assessment: Objective assessment of hyperalgesia by the Von Frey filaments test	60 and 300 g Von Frey filaments test on the thoracotomy area	3 months after surgery
Heath related quality of life	measured by EQ-5D-5L questionnaire	3 months after surgery
Assessment of sedation in the operating room	measured by MOAA/S scale ( Modified Observer's Assessment of alternes/sedation Scale)	baseline

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: University of Lille Nord de France
• Investigators: Principal Investigator: Jacques Desbordes, MD, Lille University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): May 24, 2019
• Study Completion (Actual): May 24, 2019

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 17, 2017
• First Posted (Actual): May 18, 2017

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: quality of life; neuropathic pain; thoracotomy; gabapentin; chronic post-thoracotomy pain; acute post-thoracotomy pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: 2014_12; 2014-005226-35 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No