The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy | RxWiki

The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy

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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	Pain, Postoperative
Intervention	Drug: Gabapentin Drug: Placebo
Phase	Phase 3
Sponsor	University of Aarhus
Responsible Party	University of Aarhus
ClinicalTrials.gov Identifier	NCT01116583
First Received	April 27, 2010
Last Updated	September 12, 2012
Last verified	September 2012

Tracking Information[ + expand ][ + ]

First Received Date	April 27, 2010
Last Updated Date	September 12, 2012
Start Date	May 2011
Estimated Primary Completion Date	May 2013
Current 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.
Current 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]

Descriptive Information[ + expand ][ + ]

Brief Title	The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy
Official Title	The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy - A Randomized, Double-blind, Placebo-controlled Trial
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
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Condition	Pain, Postoperative
Intervention	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 Names: Gabapentin "Sandoz" 300 mgDrug: 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
Study Arm (s)	Active Comparator: Gabapentin Gabapentin group Placebo Comparator: Placebo Placebo group

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	104
Estimated Completion Date	May 2013
Estimated Primary Completion Date	May 2013
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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Hans K Pilegaard, MD, Chief Surgeon +4589495403 pilegaard@dadlnet.dk
Location Countries	Denmark

Administrative Information[ + expand ][ + ]

NCT Number	NCT01116583
Other Study ID Numbers	2007-002769-11
Has Data Monitoring Committee	Yes
Information Provided By	University of Aarhus
Study Sponsor	University of Aarhus
Collaborators	Aarhus University Hospital
Investigators	Principal Investigator: Hans K Pilegaard, MD, Chief Surgeon Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, DenmarkStudy Director: Kasper Grosen, RN, MHScS, PhDS Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, DenmarkStudy Chair: Vibeke Hjortdal, MD, Professor, DMSc, PhD Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, DenmarkStudy Chair: Mogens P Jensen, MD, Chief Physician, PhD Department of Reumatology, Aarhus University Hospital, Aarhus Hospital, DenmarkStudy Chair: Gerhard Linnemann, MD, Chief Physician Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Skejby, DenmarkStudy Chair: Vibeke Laursen, RN Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, DenmarkStudy Chair: Anette Hoejsgaard, MD Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital
Verification Date	September 2012

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