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Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy

Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00572208
Enrollment
64
Registered
2007-12-12
Start date
2008-01-31
Completion date
2009-02-28
Last updated
2009-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

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.

Interventions

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)

Sponsors

Aarhus University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pain1 month
Morphine consumption1 month

Secondary

MeasureTime frame
PONV1 month
Medication side effects1 month
Hospital stay1 month
VAS score and medication 30 days after the operation1 month

Countries

Denmark

Contacts

Primary ContactImran Parvaiz, MD
imran@dadlnet.dk+45 40547377
Backup ContactMariann T Jensen, MD
MTZ@sks.aaa.dk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026