Skip to main content
OpenTrials
Completed

NCT Number: NCT03158376

Preoperative Gabapentin for Chronic Pain After Thoracotomy (GABATHOMIE).

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Pain Chronic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Thoracic Surgery, Lille University Hospital

Lille, 59000, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gabapentin

Drug

Other names: gabapentin Biogaran 400 mg capsule

Placebo

Drug

Other names: placebo oral capsule (lactose)

Primary outcomes

  1. 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 outcomes

  1. Quantitative pain assessment: Acute postoperative pain intensity

    Time frame: Within the first 10 postoperative days

    Measured on a 11-point numeric rating scale

  2. 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.

  3. Quantitative pain assessment: volume of epidural infusion

    Time frame: Within the 5 postoperative days

    total dose of epidural local anesthetic and epidural morphine

  4. 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)

  5. 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)

  6. 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)

  7. 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

  8. 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

  9. Heath related quality of life

    Time frame: 3 months after surgery

    measured by EQ-5D-5L questionnaire

  10. Assessment of sedation in the operating room

    Time frame: baseline

    measured by MOAA/S scale ( Modified Observer's Assessment of alternes/sedation Scale)

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • University of Lille Nord de France

Registry information

Official study title

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

Acronym: GABATHOMIE

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
May 18, 2017
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.