Preoperative Gabapentin for Chronic Pain After Thoracotomy (GABATHOMIE).

Sponsor

University Hospital, Lille (Other)

Overall Status

Unknown status

CT.gov ID

NCT03158376

Collaborator

University of Lille Nord de France (Other)

238

Enrollment

Location

Arms

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Chronic Pain	Drug: Gabapentin Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

238 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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

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: incidence of neuropathic pain [postoperative day 2]
Assessed by DN4 (Neuropathic pain 4), NPSI (Neuropathic Pain Symptom Inventory) and QDSA ( Saint Antoine French questionnaire = McGill questionnaire)
Qualitative pain assessment: incidence of neuropathic pain [postoperative day 6]
Assessed by DN4 (Neuropathic pain 4), NPSI (Neuropathic Pain Symptom Inventory) and QDSA ( Saint Antoine French questionnaire = McGill 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)
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
Heath related quality of life [3 months after surgery]
measured by EQ-5D-5L questionnaire
Assessment of sedation in the operating room [baseline]
measured by MOAA/S scale ( Modified Observer's Assessment of alternes/sedation Scale)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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