Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy - Tabular View

Tracking Information

First Received Date ^ICMJE

December 11, 2007

Last Updated Date

February 12, 2009

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pain [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Morphine consumption [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00572208 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

PONV [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Medication side effects [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Hospital stay [ Time Frame: 1 month ] [ Designated as safety issue: No ]
VAS score and medication 30 days after the operation [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy

Official Title ^ICMJE

Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy

Brief Summary

In this study we will focus on the postoperative recovery. A successful postoperative recovery should bring the patient to at least to the pre-surgical level. This can probably be achieved by a multimodal approach where at least postoperative pain and PONV are managed.

The surgical injury results in immobilisation which again can result in impaired cardiac, respiratory and musculoskeletal system. Pain relief is a prerequisite for mobilisation and an early return to the pre-surgical level. The preferred drugs for postoperative pain management are opioids. Although opioids are known to be an effective analgesia, they have a series of side effects: nausea, vomiting, constipation, respiratory deficiency, delirium among others.

Gabapentin has been tested for post operative pain. Randomized Clinical Trials have reported a significant better pain scores with Gabapentin in several studies -most of them restricted to the postoperative period in the post-anaesthesia care unit in many different kind of surgeries.

We want to test if Gabapentin can be used instead of opioids for treatment of postoperative pain after heart surgery by median sternotomy.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Condition ^ICMJE

Pain, Postoperative

Intervention ^ICMJE

Drug: Gabapentin group

Study Arms / Comparison Groups

Active Comparator: Gabapentin group
No Intervention: placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2009

Estimated Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients scheduled for elective cardiac surgery with median sternotomy at the department of cardiac surgery, Aarhus University Hospital, Skejby.
Patients older than 18 years.

Exclusion Criteria:

Patients unable to cooperate.
Known allergy for Gabapentin or opioids.
Acute pancreatitis
History of gastric or peptic ulcer.
History of alcohol or drug abuse.
Chronic pain or daily intake of analgesics or corticosteroids.
Gastrointestinal obstruction
Impaired liver function.
Impaired kidney function.
Previous operation with median sternotomy
Pregnant women

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Imran Parvaiz, MD	+45 40547377	imran@dadlnet.dk
Contact: Mariann T Jensen, MD		MTZ@sks.aaa.dk

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00572208

Responsible Party

Vibeke Hjortdal, Professor, Consultant, Dr. Sci., PhD., Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby

Study ID Numbers ^ICMJE

Gabapentin01, 2007-001479-12

Study Sponsor ^ICMJE

Aarhus University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Vibeke Hjortdal, MD, Dr.sci

Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby

Information Provided By

University of Aarhus

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP