The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy

Summary

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

Conditions

• Pain, Postoperative

Interventions

DRUG

Gabapentin

Preoperatively (2 hours before surgery): 4 gabapentin capsules each containing 300 mg gabapentin (total gabapentin dose 1200 mg) Postoperative day 1: gabapentin 300 mg x 2 (total gabapentin dose 600 mg) Postoperative day 2: gabapentin 300 mg x 3 (total gabapentin dose 900 mg) Postoperative day 3: gabapentin 300 mg x 4 (total gabapentin dose 1200 mg) Postoperative day 4: gabapentin 300 mg x 4 (total gabapentin dose 1200 mg) Postoperative day 5: gabapentin 300 mg x 4 (total gabapentin dose 1200 mg)

DRUG

Placebo

Preoperatively (2 hours before surgery): 4 placebo capsules Postoperative day 1: 1 placebo capsule x 2 Postoperative day 2: 1 placebo capsule x 3 Postoperative day 3: 1 placebo capsule x 4 Postoperative day 4: 1 placebo capsule x 4 Postoperative day 5: 1 placebo capsule x 4

Sponsors & Collaborators

• Aarhus University Hospital Skejby

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Hans K Pilegaard, MD, Chief Surgeon · Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark

• Kasper Grosen, RN, MHScS, PhDS · Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark

• Vibeke Hjortdal, MD, Professor, DMSc, PhD · Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark

• Mogens P Jensen, MD, Chief Physician, PhD · Department of Reumatology, Aarhus University Hospital, Aarhus Hospital, Denmark

• Gerhard Linnemann, MD, Chief Physician · Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Skejby, Denmark

• Vibeke Laursen, RN · Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark

• Anette Hoejsgaard, MD · Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-05-31

Primary Completion

2013-11-30

Completion

2013-11-30

Countries

• Denmark

Study Locations