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

This study has been completed.
Sponsor:
Collaborator:
Aarhus University Hospital Skejby
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01116583
First received: April 27, 2010
Last updated: August 4, 2014
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
Pain, Postoperative
Drug: Gabapentin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy - A Randomized, Double-blind, Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Persistent post surgical pain [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
    Pain is assessed by means of the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). Persistent postoperative pain is measured both on a 11-point numeric pain rating scale and on a 10 cm visual analog scale (VAS). A score >=3 is considered as moderate pain.

  • Acute postoperative pain [ Time Frame: Within the first 5 postoperative days ] [ Designated as safety issue: No ]
    Acute postoperative pain is measured on a 11-point numeric rating scale both at rest and when coughing/sitting up. General pain intensity and specific (shoulder) pain intensity are measured. On postoperative day 4 pain is furthermore assessed by means of the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). A score >=3 is considered as moderate pain.

  • Usage of epidural infusion of local and opioid analgesics (ml) [ Time Frame: Within the first 5 postoperative days ] [ Designated as safety issue: No ]
  • Persistent post surgical pain [ Time Frame: 6 months following surgery ] [ Designated as safety issue: No ]
    Pain is assessed by means of the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). Persistent postoperative pain is measured both on a 11-point numeric pain rating scale and on a 10 cm visual analog scale (VAS). A score >=3 is considered as moderate pain.

  • Persistent post surgical pain [ Time Frame: 12 months following surgery ] [ Designated as safety issue: No ]
    Pain is assessed by means of the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). Persistent postoperative pain is measured both on a 11-point numeric pain rating scale and on a 10 cm visual analog scale (VAS). A score >=3 is considered as moderate pain.

  • Early postoperative pain [ Time Frame: 14 days (+/-3 days) following discharge ] [ Designated as safety issue: No ]
    Early postoperative pain is measured on day 14 (+/-3 days) following discharge pain using the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). A score >=3 is considered as moderate pain.


Secondary Outcome Measures:
  • Consumption of opioid analgesics [ Time Frame: Within the first 5 postoperative days ] [ Designated as safety issue: No ]
  • Time to first request for additional analgesics [ Time Frame: Within the first 5 postoperative days ] [ Designated as safety issue: No ]
  • Analgesia related side-effects [ Time Frame: Within the first 5 postoperative days ] [ Designated as safety issue: No ]
    Evaluation of the presence and/or severity of confusion, hallucinations, nausea, vomiting, usage of antiemetic drugs, urinary retention, sedation, pruitus, headache, respiratory depression, motor blockade and dizziness

  • Convalescence of gastrointestinal function [ Time Frame: Within the first 5 postoperative days ] [ Designated as safety issue: No ]
    Convalescence of gastrointestinal function (time to first defecation)

  • Health related quality of life [ Time Frame: Day 14 (+/-3 days) following discharge ] [ Designated as safety issue: No ]
    Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.

  • Patient satisfaction [ Time Frame: Within the first 5 postoperative days ] [ Designated as safety issue: No ]
    Patient satisfaction is assesed with the EORCT-INPATSAT32 questionnaire

  • Intensity of preoperative anxiety [ Time Frame: 2 hours after administration of the first dose of study medication ] [ Designated as safety issue: No ]
    Anxiety is measured on a 11-point numeric rating scale (NRS).

  • Convalescence of lung function (spirometry) [ Time Frame: Within the first five postoperative days ] [ Designated as safety issue: No ]
    FVC, FEV-1 and PEF is measured.

  • Sleep quality [ Time Frame: Within the first five postoperative days ] [ Designated as safety issue: No ]
    Sleep quality is measured on a 11-point numeric rating scale (NRS)

  • Walking distance (meters) [ Time Frame: Postoperative day 3 ] [ Designated as safety issue: No ]
    Ability to walk is measured by means of the 6-minutes walking test on postoperative day 3.

  • Fatigue [ Time Frame: Within the first 5 postoperative days ] [ Designated as safety issue: No ]
    Fatigue is measured on a 4-point verbal rating scale (0=None, 1=Mild, 2=Moderate, 3=Severe).

  • Hospital length of stay (days) [ Time Frame: At time of discharge ] [ Designated as safety issue: No ]
  • Health related quality of life [ Time Frame: 3 months following surgery ] [ Designated as safety issue: No ]
    Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.

  • Health related quality of life [ Time Frame: 6 months following surgery ] [ Designated as safety issue: No ]
    Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.

  • Health related quality of life [ Time Frame: 12 months following surgery ] [ Designated as safety issue: No ]
    Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.

  • Use of a vasopressor agent to correct hypotension [ Time Frame: Within the first 5 days of surgery ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: May 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Gabapentin
Gabapentin group
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)

Other Name: Gabapentin "Sandoz" 300 mg
Placebo Comparator: Placebo
Placebo group
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


  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116583

Locations
Denmark
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital Skejby
Investigators
Principal Investigator: Hans K Pilegaard, MD, Chief Surgeon Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark
Study Director: Kasper Grosen, RN, MHScS, PhDS Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark
Study Chair: Vibeke Hjortdal, MD, Professor, DMSc, PhD Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark
Study Chair: Mogens P Jensen, MD, Chief Physician, PhD Department of Reumatology, Aarhus University Hospital, Aarhus Hospital, Denmark
Study Chair: Gerhard Linnemann, MD, Chief Physician Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Skejby, Denmark
Study Chair: Vibeke Laursen, RN Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark
Study Chair: Anette Hoejsgaard, MD Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01116583     History of Changes
Other Study ID Numbers: 2007-002769-11
Study First Received: April 27, 2010
Last Updated: August 4, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Gabapentin
Thoracotomy
Pain, Postoperative
Analgesia
Recovery of Function
Quality of Life

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on August 26, 2014