The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy (GABATEA)
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Postoperative focused on measuring Gabapentin, Thoracotomy, Pain, Postoperative, Analgesia, Recovery of Function, Quality of Life
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
Sites / Locations
- Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Gabapentin
Placebo
Arm Description
Gabapentin group
Placebo group
Outcomes
Primary Outcome Measures
Persistent post surgical pain
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
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)
Persistent post surgical pain
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
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
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 to first request for additional analgesics
Analgesia related side-effects
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
Convalescence of gastrointestinal function (time to first defecation)
Health related quality of life
Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.
Patient satisfaction
Patient satisfaction is assesed with the EORCT-INPATSAT32 questionnaire
Intensity of preoperative anxiety
Anxiety is measured on a 11-point numeric rating scale (NRS).
Convalescence of lung function (spirometry)
FVC, FEV-1 and PEF is measured.
Sleep quality
Sleep quality is measured on a 11-point numeric rating scale (NRS)
Walking distance (meters)
Ability to walk is measured by means of the 6-minutes walking test on postoperative day 3.
Fatigue
Fatigue is measured on a 4-point verbal rating scale (0=None, 1=Mild, 2=Moderate, 3=Severe).
Hospital length of stay (days)
Health related quality of life
Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.
Health related quality of life
Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.
Health related quality of life
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
Full Information
NCT ID
NCT01116583
First Posted
April 27, 2010
Last Updated
August 4, 2014
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital Skejby
1. Study Identification
Unique Protocol Identification Number
NCT01116583
Brief Title
The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy
Acronym
GABATEA
Official Title
The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy - A Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital Skejby
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Gabapentin, Thoracotomy, Pain, Postoperative, Analgesia, Recovery of Function, Quality of Life
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gabapentin
Arm Type
Active Comparator
Arm Description
Gabapentin group
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo group
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Gabapentin "Sandoz" 300 mg
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Persistent post surgical pain
Description
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.
Time Frame
3 months after surgery
Title
Acute postoperative pain
Description
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.
Time Frame
Within the first 5 postoperative days
Title
Usage of epidural infusion of local and opioid analgesics (ml)
Time Frame
Within the first 5 postoperative days
Title
Persistent post surgical pain
Description
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.
Time Frame
6 months following surgery
Title
Persistent post surgical pain
Description
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.
Time Frame
12 months following surgery
Title
Early postoperative pain
Description
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.
Time Frame
14 days (+/-3 days) following discharge
Secondary Outcome Measure Information:
Title
Consumption of opioid analgesics
Time Frame
Within the first 5 postoperative days
Title
Time to first request for additional analgesics
Time Frame
Within the first 5 postoperative days
Title
Analgesia related side-effects
Description
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
Time Frame
Within the first 5 postoperative days
Title
Convalescence of gastrointestinal function
Description
Convalescence of gastrointestinal function (time to first defecation)
Time Frame
Within the first 5 postoperative days
Title
Health related quality of life
Description
Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.
Time Frame
Day 14 (+/-3 days) following discharge
Title
Patient satisfaction
Description
Patient satisfaction is assesed with the EORCT-INPATSAT32 questionnaire
Time Frame
Within the first 5 postoperative days
Title
Intensity of preoperative anxiety
Description
Anxiety is measured on a 11-point numeric rating scale (NRS).
Time Frame
2 hours after administration of the first dose of study medication
Title
Convalescence of lung function (spirometry)
Description
FVC, FEV-1 and PEF is measured.
Time Frame
Within the first five postoperative days
Title
Sleep quality
Description
Sleep quality is measured on a 11-point numeric rating scale (NRS)
Time Frame
Within the first five postoperative days
Title
Walking distance (meters)
Description
Ability to walk is measured by means of the 6-minutes walking test on postoperative day 3.
Time Frame
Postoperative day 3
Title
Fatigue
Description
Fatigue is measured on a 4-point verbal rating scale (0=None, 1=Mild, 2=Moderate, 3=Severe).
Time Frame
Within the first 5 postoperative days
Title
Hospital length of stay (days)
Time Frame
At time of discharge
Title
Health related quality of life
Description
Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.
Time Frame
3 months following surgery
Title
Health related quality of life
Description
Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.
Time Frame
6 months following surgery
Title
Health related quality of life
Description
Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.
Time Frame
12 months following surgery
Title
Use of a vasopressor agent to correct hypotension
Time Frame
Within the first 5 days of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans K Pilegaard, MD, Chief Surgeon
Organizational Affiliation
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kasper Grosen, RN, MHScS, PhDS
Organizational Affiliation
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Vibeke Hjortdal, MD, Professor, DMSc, PhD
Organizational Affiliation
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mogens P Jensen, MD, Chief Physician, PhD
Organizational Affiliation
Department of Reumatology, Aarhus University Hospital, Aarhus Hospital, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gerhard Linnemann, MD, Chief Physician
Organizational Affiliation
Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Skejby, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vibeke Laursen, RN
Organizational Affiliation
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anette Hoejsgaard, MD
Organizational Affiliation
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
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The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy
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