Preoperative Gabapentin for Chronic Pain After Thoracotomy (GABATHOMIE).

University Hospital, Lille201 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

201

Conditions

Postoperative Pain Chronic Pain

Interventions

GabapentinDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Thoracic Surgery, Lille University Hospital

Lille, France

Outcomes

Primary Outcomes

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.

Time frame: 3 months after surgery

Secondary Outcomes

Quantitative pain assessment: Acute postoperative pain intensity

Measured on a 11-point numeric rating scale

Time frame: 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.

Time frame: Within the first 3 months after surgery

Quantitative pain assessment: volume of epidural infusion

total dose of epidural local anesthetic and epidural morphine

Time frame: 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)

Time frame: 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)

Time frame: 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)

Data from ClinicalTrials.gov

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