The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy

NCT ID: NCT01116583

Last Updated: 2014-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Gabapentin

Gabapentin group

Group Type: ACTIVE_COMPARATOR

Gabapentin

Intervention Type: DRUG

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)

Placebo

Placebo group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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)

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Gabapentin "Sandoz" 300 mg

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital Skejby

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans K Pilegaard, MD, Chief Surgeon

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark

Kasper Grosen, RN, MHScS, PhDS

Role: STUDY_DIRECTOR

Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark

Vibeke Hjortdal, MD, Professor, DMSc, PhD

Role: STUDY_CHAIR

Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark

Mogens P Jensen, MD, Chief Physician, PhD

Role: STUDY_CHAIR

Department of Reumatology, Aarhus University Hospital, Aarhus Hospital, Denmark

Gerhard Linnemann, MD, Chief Physician

Role: STUDY_CHAIR

Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Skejby, Denmark

Vibeke Laursen, RN

Role: STUDY_CHAIR

Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark

Anette Hoejsgaard, MD

Role: STUDY_CHAIR

Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital

Locations

Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby

Aarhus N, , Denmark

Countries

Denmark

Other Identifiers

2007-002769-11

Identifier Type: -

Identifier Source: org_study_id