NCT00572208

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2007

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 13, 2009

Status Verified

February 1, 2009

Enrollment Period

1.1 years

First QC Date

December 11, 2007

Last Update Submit

February 12, 2009

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (2)

  • Pain

    1 month

  • Morphine consumption

    1 month

Secondary Outcomes (4)

  • PONV

    1 month

  • Medication side effects

    1 month

  • Hospital stay

    1 month

  • VAS score and medication 30 days after the operation

    1 month

Study Arms (2)

1

ACTIVE COMPARATOR

Gabapentin group

Drug: Gabapentin group

2

NO INTERVENTION

placebo

Interventions

Gabapentin groupDRUG

Gabapentin group: Preoperative (2 h before surgery): Tablet Gabapentin 1200 mg (blinded) 1. st Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded) 2. nd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded) 3. rd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded) 4. th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded) 5. th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby

Aarhus, 8200, Denmark

NOT YET RECRUITING

Cardiothoracic and vascular department, Skejby Sygehus

Aarhus, Denmark

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Vibeke Hjortdal, MD, Dr.sci

    Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Parvaiz, MD

CONTACT

+45 40547377imran@dadlnet.dk

Mariann T Jensen, MD

CONTACT

MTZ@sks.aaa.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 11, 2007

First Posted

December 12, 2007

Study Start

January 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

February 13, 2009

Record last verified: 2009-02

Locations

DK(2)