Preoperative Gabapentin for Chronic Pain After Thoracotomy (GABATHOMIE).

Chronic Pain Clinical Trial

— GABATHOMIE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03158376
• Other study ID #: 2014_12
• Secondary ID: 2014-005226-35
• Status: Completed
• Phase: Phase 3
• Start date: September 2015
• Est. completion date: May 24, 2019

Study information

• Verified date: November 2022
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: May 24, 2019
• Est. primary completion date: May 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Postoperative Pain

Intervention

Drug:
• Gabapentin

• Placebo

Locations

Country	Name	City	State
France	Department of Thoracic Surgery, Lille University Hospital	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	University of Lille Nord de France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months after surgery
Secondary	Quantitative pain assessment: Acute postoperative pain intensity	Measured on a 11-point numeric rating scale	Within the first 10 postoperative days
Secondary	Quantitative pain assessment: Rescue analgesics requirement	consumption of additional analgesics (opioids, nefopam or non steroidal anti-inflammatory drug) and time to first request.	Within the first 3 months after surgery
Secondary	Quantitative pain assessment: volume of epidural infusion	total dose of epidural local anesthetic and epidural morphine	Within the 5 postoperative days
Secondary	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)	postoperative day 2
Secondary	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)	postoperative day 6
Secondary	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)	3 months after surgery
Secondary	Qualitative pain assessment: Rescue analgesics requirement for neuropathic pain	Time to first request and consumption (doses and length of treatment) of gapapentinoids, amitriptyline	within the first 3 months after surgery
Secondary	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	3 months after surgery
Secondary	Heath related quality of life	measured by EQ-5D-5L questionnaire	3 months after surgery
Secondary	Assessment of sedation in the operating room	measured by MOAA/S scale ( Modified Observer's Assessment of alternes/sedation Scale)	baseline