Preoperative Gabapentin for Chronic Pain After Thoracotomy (GABATHOMIE).

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

Detailed Description
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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).

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

Conditions
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Postoperative Pain, Chronic Pain

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gabapentin group<br>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<br> <br> * Other names: gabapentin Biogaran 400 mg capsule;|
| Placebo Comparator: placebo group<br>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<br> <br> * Other names: placebo oral capsule (lactose);|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gabapentin, thoracotomy, chronic post-thoracotomy pain, acute post-thoracotomy pain, quality of life, neuropathic pain