Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
150 participants
INTERVENTIONAL
2011-12-12
2013-03-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Control: Placebo + Placebo
Placebo capsules and Placebo infusion
Placebo capsules
Single capsule (2hrs) pre operatively and twice daily post operatively for 10 days, followed by dose reduction to single capsule twice daily for 2 days and finally to single capsule twice daily for 2 days
Placebo infusion
Normal saline placebo intravenous infusion for 48 hours
Pregabalin and Placebo infusion
Pregabalin capsules and Placebo infusion
Pregabalin
150mg (2hrs) pre operatively and twice daily post operatively for 10 days, followed by dose reduction to 75mg twice daily for 2 days and finally to 50 mg twice daily for 2 days
Placebo infusion
Normal saline placebo intravenous infusion for 48 hours
Pregabalin + Ketamine infusion
Pregabalin capsules + Ketamine infusion
Pregabalin
150mg (2hrs) pre operatively and twice daily post operatively for 10 days, followed by dose reduction to 75mg twice daily for 2 days and finally to 50 mg twice daily for 2 days
Ketamine infusion
0.1mg/kg/hr for 48 hours post operatively
Interventions
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Pregabalin
150mg (2hrs) pre operatively and twice daily post operatively for 10 days, followed by dose reduction to 75mg twice daily for 2 days and finally to 50 mg twice daily for 2 days
Ketamine infusion
0.1mg/kg/hr for 48 hours post operatively
Placebo capsules
Single capsule (2hrs) pre operatively and twice daily post operatively for 10 days, followed by dose reduction to single capsule twice daily for 2 days and finally to single capsule twice daily for 2 days
Placebo infusion
Normal saline placebo intravenous infusion for 48 hours
Eligibility Criteria
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Inclusion Criteria
* First time sternotomy for all cardiac surgery
* Patient aged 18 - 80 years
Exclusion Criteria
* Previous sternotomy
* Preoperative renal failure (eGFR \<60 ml/min)
* History of chronic non-anginal pain
* Chronic pain medication other than paracetamol and non-steroidal anti-inflammatory drugs
* Concurrent use of oxycodone, lorazepam, or ethanol.
* Concurrent use of any drugs for neuropathic pain e.g. antiepileptics, antidepressants
* Allergy to pregabalin, gabapentin or ketamine
* Pregnancy
* Limited understanding of numerical scoring scales
* Previous participation in other trials investigating analgesic agents or any IMP in previous three months
18 Years
80 Years
ALL
No
Sponsors
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Barts & The London NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Sibtain Anwar, MA MB FRCA
Role: STUDY_DIRECTOR
Barts and The London NHS Trust
Locations
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Pain and Ananesthesia Research Centre, Barts and The London NHS Trust
London, , United Kingdom
Countries
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Other Identifiers
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2010-024462-21
Identifier Type: REGISTRY
Identifier Source: secondary_id
11/H0703/7
Identifier Type: REGISTRY
Identifier Source: secondary_id
Reda 007583
Identifier Type: -
Identifier Source: org_study_id
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