Preoperative Gabapentin for Chronic Pain After Thoracotomy (GABATHOMIE).

Overview

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

Full Title of Study: “Perioperative Gabapentin for Chronic Post-thoracotomy Pain: a Randomized, Double Blind, Placebo-controlled Study.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2019

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).

Interventions

  • Drug: Gabapentin
  • Drug: Placebo

Arms, Groups and Cohorts

  • 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)
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Persistent chronic post-thoracotomy pain
    • Time Frame: 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 Measures

  • Quantitative pain assessment: Acute postoperative pain intensity
    • Time Frame: Within the first 10 postoperative days
    • Measured on a 11-point numeric rating scale
  • Quantitative pain assessment: Rescue analgesics requirement
    • Time Frame: 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
    • Time Frame: Within the 5 postoperative days
    • total dose of epidural local anesthetic and epidural morphine
  • Qualitative pain assessment: incidence of neuropathic pain
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 3 months after surgery
    • 60 and 300 g Von Frey filaments test on the thoracotomy area
  • Heath related quality of life
    • Time Frame: 3 months after surgery
    • measured by EQ-5D-5L questionnaire
  • Assessment of sedation in the operating room
    • Time Frame: baseline
    • measured by MOAA/S scale ( Modified Observer’s Assessment of alternes/sedation Scale)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Lille
  • Collaborator
    • University of Lille Nord de France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jacques Desbordes, MD, Principal Investigator, Lille University Hospital
  • Overall Contact(s)
    • Jacques Desbordes, MD, jacques.desbordes@chru-lille.fr

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