The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy (GABATEA)
This study is currently recruiting participants.
Verified September 2012 by University of Aarhus
Sponsor:
University of Aarhus
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01116583
First received: April 27, 2010
Last updated: September 12, 2012
Last verified: September 2012
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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 ]
| Estimated Enrollment: | 104 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116583
Contacts
| Contact: Hans K Pilegaard, MD, Chief Surgeon | +4589495403 | pilegaard@dadlnet.dk |
| Contact: Kasper Grosen, RN, MHScS, PhDS | +4589495443 | kasper.grosen@ki.au.dk |
Locations
| Denmark | |
| Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby | Recruiting |
| Aarhus N, Denmark, 8200 | |
| Contact: Hans K Pilegaard, MD, Chief Surgeon +4589495403 pilegaard@dadlnet.dk | |
| Contact: Kasper Grosen, RN, MHScS, PhDS +4589495443 | |
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
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: | September 12, 2012 |
| 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 Gamma-Aminobutyric Acid 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 GABA Agents |
ClinicalTrials.gov processed this record on May 16, 2013