The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy (GABATEA)

University of Aarhus

Status and phase: Completed; Phase 3

Conditions: Pain, Postoperative

Treatments: Drug: Gabapentin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01116583

2007-002769-11

Details and patient eligibility

About

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.

The main hypothesis is that gabapentin reduces the proportion of patients who develop a persistent pain condition following thoracotomy from 50% to 20%.

Furthermore gabapentin is expected to reduce both pain intensity measured on a 11-point numerical rating scale, usage of epidural infusions of local and/or opioid analgesics, morbidity, hospital length of stay, consumption of opioid analgesics and analgesia-related side-effects.

In addition gabapentin is expected to improve postoperative recovery by means of postoperative lung function, walking ability, health related quality of life and patient satisfaction

Enrollment: 104 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective lung resection via thoracotomy
• Age > 18 and < 80 years

Exclusion criteria

• Inability to answer the detailed questionnaires 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 opioid 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 illegal substance abuse.
• A history of gastric or duodenal ulcer
• Gastrointestinal obstruction
• Pregnancy
• Participation in another intervention study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 2 patient groups, including a placebo group

Gabapentin

Active Comparator group

Description:

Gabapentin group

Treatment:

Drug: Gabapentin

Placebo

Placebo Comparator group

Description:

Placebo group

Treatment:

Drug: Placebo