Clinical trial NCT03158376: Preoperative Gabapentin for Chronic Pain After Thoracotomy (GABATHOMIE).
Official title: Perioperative Gabapentin for Chronic Post-thoracotomy Pain: a Randomized, Double Blind, Placebo-controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Chronic Pain
Keywords: gabapentin
thoracotomy
chronic post-thoracotomy pain
acute post-thoracotomy pain
quality of life
neuropathic pain
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: University of Lille Nord de France
First posted: 2017-05-18
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Persistent chronic post-thoracotomy pain
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Quantitative pain assessment: Acute postoperative pain intensity
timeFrame: Within the first 10 postoperative days
measure: Quantitative pain assessment: Rescue analgesics requirement
timeFrame: Within the first 3 months after surgery
measure: Quantitative pain assessment: volume of epidural infusion
timeFrame: Within the 5 postoperative days
measure: Qualitative pain assessment: incidence of neuropathic pain
timeFrame: postoperative day 2
measure: Qualitative pain assessment: incidence of neuropathic pain
timeFrame: postoperative day 6
measure: Qualitative pain assessment: incidence of neuropathic pain
timeFrame: 3 months after surgery
measure: Qualitative pain assessment: Rescue analgesics requirement for neuropathic pain
timeFrame: within the first 3 months after surgery
measure: Qualitative pain assessment: Objective assessment of hyperalgesia by the Von Frey filaments test
timeFrame: 3 months after surgery
measure: Heath related quality of life
timeFrame: 3 months after surgery
measure: Assessment of sedation in the operating room
timeFrame: baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Department of Thoracic Surgery, Lille University Hospital
Study officials:
affiliation: Lille University Hospital
name: Jacques Desbordes, MD
role: PRINCIPAL_INVESTIGATOR
References: