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Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Gabapentin group
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients unable to cooperate.
  2. Known allergy for Gabapentin or opioids.
  3. Acute pancreatitis
  4. History of gastric or peptic ulcer.
  5. History of alcohol or drug abuse.
  6. Chronic pain or daily intake of analgesics or corticosteroids.
  7. Gastrointestinal obstruction
  8. Impaired liver function.
  9. Impaired kidney function.
  10. Previous operation with median sternotomy
  11. Pregnant women

Sites / Locations

  • Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby
  • Cardiothoracic and vascular department, Skejby SygehusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1

2

Arm Description

Gabapentin group

placebo

Outcomes

Primary Outcome Measures

Pain
Morphine consumption

Secondary Outcome Measures

PONV
Medication side effects
Hospital stay
VAS score and medication 30 days after the operation

Full Information

First Posted
December 11, 2007
Last Updated
February 12, 2009
Sponsor
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00572208
Brief Title
Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy
Official Title
Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2009 (Anticipated)
Study Completion Date
February 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Gabapentin group
Arm Title
2
Arm Type
No Intervention
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Gabapentin group
Intervention Description
Gabapentin group: Preoperative (2 h before surgery): Tablet Gabapentin 1200 mg (blinded) st Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded) nd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded) rd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded) th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded) th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
Primary Outcome Measure Information:
Title
Pain
Time Frame
1 month
Title
Morphine consumption
Time Frame
1 month
Secondary Outcome Measure Information:
Title
PONV
Time Frame
1 month
Title
Medication side effects
Time Frame
1 month
Title
Hospital stay
Time Frame
1 month
Title
VAS score and medication 30 days after the operation
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Parvaiz, MD
Phone
+45 40547377
Email
imran@dadlnet.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Mariann T Jensen, MD
Email
MTZ@sks.aaa.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vibeke Hjortdal, MD, Dr.sci
Organizational Affiliation
Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Imran Parvaiz, MD
Phone
+45 40547377
Email
imran@dadlnet.dk
First Name & Middle Initial & Last Name & Degree
Mariann T Jensen, MD
Email
MTZ@sks.aaa.dk
First Name & Middle Initial & Last Name & Degree
Vibeke Hjortdal, MD, Dr.Sci
First Name & Middle Initial & Last Name & Degree
Imran Parvaiz, MD
First Name & Middle Initial & Last Name & Degree
Mariann T Jensen, MD
Facility Name
Cardiothoracic and vascular department, Skejby Sygehus
City
Aarhus
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariann Tang Jensen, MD

12. IPD Sharing Statement

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Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy

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