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: 12.0 Level: LLT Classification code 10002708 Term: Anterior thoracotomy MedDRA version: 12.0 Level: LLT Classification code 10036372 Term: Postero-lateral thoracotomy MedDRA version: 1
Conditions
Interventions
Trade Name: Gabapentin
Product Name: Gabapentin "Sandoz"
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: GABAPENTIN
CAS Number: 60142963
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Department of Cardiothoracic and Vascular Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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: 1) Pain, NRS-score 2) Morphine consumption Secondary endpoints: 1) Mobility (6 minutes walking test) 2) Lung function (spirometry) 3) Side effects 3) Hospital stay 4) Health related quality of life 5) Patient satisfaction | — |
Countries
Denmark
Outcome results
None listed