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Preoperative Gabapentin for Chronic Pain After Thoracotomy (GABATHOMIE). (GABATHOMIE)

Primary Purpose

Postoperative Pain, Chronic Pain

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring gabapentin, thoracotomy, chronic post-thoracotomy pain, acute post-thoracotomy pain, quality of life, neuropathic pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Thoracic Surgery, Lille University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

gabapentin group

placebo group

Arm Description

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)

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

Outcomes

Primary Outcome Measures

Persistent chronic post-thoracotomy pain
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
Measured on a 11-point numeric rating scale
Quantitative pain assessment: Rescue analgesics requirement
consumption of additional analgesics (opioids, nefopam or non steroidal anti-inflammatory drug) and time to first request.
Quantitative pain assessment: volume of epidural infusion
total dose of epidural local anesthetic and epidural morphine
Qualitative pain assessment: incidence of neuropathic pain
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
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
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 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
60 and 300 g Von Frey filaments test on the thoracotomy area
Heath related quality of life
measured by EQ-5D-5L questionnaire
Assessment of sedation in the operating room
measured by MOAA/S scale ( Modified Observer's Assessment of alternes/sedation Scale)

Full Information

First Posted
May 16, 2017
Last Updated
November 3, 2022
Sponsor
University Hospital, Lille
Collaborators
University of Lille Nord de France
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1. Study Identification

Unique Protocol Identification Number
NCT03158376
Brief Title
Preoperative Gabapentin for Chronic Pain After Thoracotomy (GABATHOMIE).
Acronym
GABATHOMIE
Official Title
Perioperative Gabapentin for Chronic Post-thoracotomy Pain: a Randomized, Double Blind, Placebo-controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
May 24, 2019 (Actual)
Study Completion Date
May 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
University of Lille Nord de France

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Chronic Pain
Keywords
gabapentin, thoracotomy, chronic post-thoracotomy pain, acute post-thoracotomy pain, quality of life, neuropathic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gabapentin group
Arm Type
Experimental
Arm Description
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)
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
gabapentin Biogaran 400 mg capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo oral capsule (lactose)
Primary Outcome Measure Information:
Title
Persistent chronic post-thoracotomy pain
Description
Pain intensity is measured on a 11-point numeric pain rating scale ; a score >=0 is considered as chronic pain.
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
Quantitative pain assessment: Acute postoperative pain intensity
Description
Measured on a 11-point numeric rating scale
Time Frame
Within the first 10 postoperative days
Title
Quantitative pain assessment: Rescue analgesics requirement
Description
consumption of additional analgesics (opioids, nefopam or non steroidal anti-inflammatory drug) and time to first request.
Time Frame
Within the first 3 months after surgery
Title
Quantitative pain assessment: volume of epidural infusion
Description
total dose of epidural local anesthetic and epidural morphine
Time Frame
Within the 5 postoperative days
Title
Qualitative pain assessment: incidence of neuropathic pain
Description
Assessed by DN4 (Neuropathic pain 4), NPSI (Neuropathic Pain Symptom Inventory) and QDSA ( Saint Antoine French questionnaire = McGill questionnaire)
Time Frame
postoperative day 2
Title
Qualitative pain assessment: incidence of neuropathic pain
Description
Assessed by DN4 (Neuropathic pain 4), NPSI (Neuropathic Pain Symptom Inventory) and QDSA ( Saint Antoine French questionnaire = McGill questionnaire)
Time Frame
postoperative day 6
Title
Qualitative pain assessment: incidence of neuropathic pain
Description
Assessed by DN4 (Neuropathic pain 4), NPSI (Neuropathic Pain Symptom Inventory) and QDSA ( Saint Antoine French questionnaire = McGill questionnaire)
Time Frame
3 months after surgery
Title
Qualitative pain assessment: Rescue analgesics requirement for neuropathic pain
Description
Time to first request and consumption (doses and length of treatment) of gapapentinoids, amitriptyline
Time Frame
within the first 3 months after surgery
Title
Qualitative pain assessment: Objective assessment of hyperalgesia by the Von Frey filaments test
Description
60 and 300 g Von Frey filaments test on the thoracotomy area
Time Frame
3 months after surgery
Title
Heath related quality of life
Description
measured by EQ-5D-5L questionnaire
Time Frame
3 months after surgery
Title
Assessment of sedation in the operating room
Description
measured by MOAA/S scale ( Modified Observer's Assessment of alternes/sedation Scale)
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Desbordes, MD
Organizational Affiliation
Lille University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Thoracic Surgery, Lille University Hospital
City
Lille
ZIP/Postal Code
59000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Preoperative Gabapentin for Chronic Pain After Thoracotomy (GABATHOMIE).

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