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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 pain

Acute 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 analgesics

Time 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

Page last updated: August 20, 2015

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