Preoperative Gabapentin for Chronic Pain After Thoracotomy (GABATHOMIE).
- Registration Number
- NCT03158376
- Lead Sponsor
- University Hospital, Lille
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 201
- age > 18 years
- elective lung resection via thoracotomy
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo group Placebo * 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 gabapentin group Gabapentin * 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)
- Primary Outcome Measures
Name Time Method Persistent chronic post-thoracotomy pain 3 months after surgery Pain intensity is measured on a 11-point numeric pain rating scale ; a score \>=0 is considered as chronic pain.
- Secondary Outcome Measures
Name Time Method Heath related quality of life 3 months after surgery measured by EQ-5D-5L questionnaire
Qualitative pain assessment: incidence of neuropathic pain 3 months after surgery Assessed by DN4 (Neuropathic pain 4), NPSI (Neuropathic Pain Symptom Inventory) and QDSA ( Saint Antoine French questionnaire = McGill questionnaire)
Quantitative pain assessment: Acute postoperative pain intensity Within the first 10 postoperative days Measured on a 11-point numeric rating scale
Quantitative pain assessment: Rescue analgesics requirement Within the first 3 months after surgery consumption of additional analgesics (opioids, nefopam or non steroidal anti-inflammatory drug) and time to first request.
Quantitative pain assessment: volume of epidural infusion Within the 5 postoperative days total dose of epidural local anesthetic and epidural morphine
Qualitative pain assessment: Rescue analgesics requirement for neuropathic pain within the first 3 months after surgery Time to first request and consumption (doses and length of treatment) of gapapentinoids, amitriptyline
Qualitative pain assessment: Objective assessment of hyperalgesia by the Von Frey filaments test 3 months after surgery 60 and 300 g Von Frey filaments test on the thoracotomy area
Assessment of sedation in the operating room baseline measured by MOAA/S scale ( Modified Observer's Assessment of alternes/sedation Scale)
Trial Locations
- Locations (1)
Department of Thoracic Surgery, Lille University Hospital
🇫🇷Lille, France