THE EFFECT OF GABAPENTIN ON THORACIC EPIDURAL ANALGESIA FOLLOWING THORACOTOMY – A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL - GABATEA

Phase 1

Conditions: The purpose of this trial is to investigate the effect of gabapentin on thoracic epidural analgesia following thoracotomy, including assessment of both analgesia, pain intensity, pain quality and whether or not gabapentin prevents the development of chronic pain conditions following thoracotomy.
MedDRA version: 12.0Level: LLTClassification code 10002708Term: Anterior thoracotomy
MedDRA version: 12.0Level: LLTClassification code 10036372Term: Postero-lateral thoracotomy
MedDRA version: 12.0Level: LLTClassification code 10043491Term: Thoracotomy
MedDRA version: 12.0Level: LLTClassification code 10067831Term: Post-thoracotomy pain syndrome
MedDRA version: 12.0Level: PTClassification code 10043491Term: Thoracotomy
MedDRA version: 12.0Level: PTClassification code 10067831Term: Post-thoracotomy pain syndrome
MedDRA version: 12.0Level: LLTClassification code 10036236Term: Postoperative pain relief
MedDRA version: 12.0Level: LLTClassification code 10054711Term: Postoperative pain

Registration Number: EUCTR2007-002769-11-DK

Lead Sponsor: Department of Cardiothoracic and Vascular Surgery

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 104

Inclusion Criteria

1. Patients scheduled to undergo elective lung resection via thoracotomy on a malignant indication at the Department of Cardithoracic and Vascular Surgery, Aarhus University Hospital, Skejby.

2. Age > 18 and < 80 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Inability to answer the detailed questionnaire on pain and quality of life
• Psychiatric disease (ICD-10)
• Severe renal impairment (se-creatinin > 110 mmol/l)
• Known allergy to gabapentin, morphine, bupivacaine and / or ibuprofen
• Standard use of opiod analgesics
• Treatment with anticonvulsants or tricyclic antidepressants
• Use of antacids 24 hours before the intake of study medication
• Contraindicated placement of a thoracic epidural catheter
• Previous ipsilateral thoracotomy
• Presence of a chronic pain syndrome
• Acute pancreatitis
• A history of past or current alcohol and / or ilegal substance abuse. Using the Danish National Board of Health's recommendations for weekly intake of < 14 drinks/units for women and < 21 drinks/units for men and / or former or current abuse of drugs.
• A history of gastric or duodenal ulcer
• Gastrointestinal obstruction
• Pregnancy
• Participation in another intervention study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of gabapentin on thoracale epidural analgesia after thoracotomi, including assessment and analgesia, pain intensity, pain quality, and whether gabapentin prevents the development of chronic pain conditions. <br>;Secondary Objective: To investigate the effect of gabapentin on convalescence of various body functions, potential reduction in morbidity as well as hospital length of stay, patient satisfaction and patient reported quality of life, cost and side effects, and to assess whether a potential opioid sparring effect has importance for patient safety. ;Primary end point(s): Primary endpoints: <br><br>1) Pain, NRS-score<br>2) Morphine consumption<br><br>Secondary endpoints:<br><br>1) Mobility (6 minutes walking test)<br>2) Lung function (spirometry) <br>3) Side effects<br>3) Hospital stay<br>4) Health related quality of life<br>5) Patient satisfaction<br>

Secondary Outcome Measures

Name	Time	Method

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