The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy
Information source: University of Aarhus
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative
Intervention: Gabapentin (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University of Aarhus Official(s) and/or principal investigator(s): Hans K Pilegaard, MD, Chief Surgeon, Principal Investigator, Affiliation: Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark Kasper Grosen, RN, MHScS, PhDS, Study Director, Affiliation: Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark Vibeke Hjortdal, MD, Professor, DMSc, PhD, Study Chair, Affiliation: Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark Mogens P Jensen, MD, Chief Physician, PhD, Study Chair, Affiliation: Department of Reumatology, Aarhus University Hospital, Aarhus Hospital, Denmark Gerhard Linnemann, MD, Chief Physician, Study Chair, Affiliation: Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Skejby, Denmark Vibeke Laursen, RN, Study Chair, Affiliation: Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark Anette Hoejsgaard, MD, Study Chair, Affiliation: Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital
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
Clinical Details
Official title: The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy - A Randomized, Double-blind, Placebo-controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Persistent post surgical painAcute postoperative pain Usage of epidural infusion of local and opioid analgesics (ml) Persistent post surgical pain Persistent post surgical pain Early postoperative pain
Secondary outcome: Consumption of opioid analgesicsTime to first request for additional analgesics Analgesia related side-effects Convalescence of gastrointestinal function Health related quality of life Patient satisfaction Intensity of preoperative anxiety Convalescence of lung function (spirometry) Sleep quality Walking distance (meters) Fatigue Hospital length of stay (days) Health related quality of life Health related quality of life Health related quality of life Use of a vasopressor agent to correct hypotension
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Aarhus N 8200, Denmark
Additional Information
Starting date: May 2011
Last updated: August 4, 2014
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