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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024462-21 | Registry Identifier | EudraCT | |
| 11/H0703/7 | Registry Identifier | UK REC Ref |
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The use of pre-emptive analgesia to prevent pain following sternotomy for cardiac surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control: Placebo + Placebo | Placebo Comparator | Placebo capsules and Placebo infusion |
|
| Pregabalin and Placebo infusion | Active Comparator | Pregabalin capsules and Placebo infusion |
|
| Pregabalin + Ketamine infusion | Active Comparator | Pregabalin capsules + Ketamine infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale (NRS) pain score (around sternotomy incision site) post surgery, at rest and following 3 maximal coughs. | 3 and 6 months post sternotomy |
| Measure | Description | Time Frame |
|---|---|---|
| Total morphine consumption at 24 hours post surgery | 24 hours post surgery | |
| Visual Analogue Scale (VAS) scores at 24 hrs post surgery, at rest and following 3 maximal coughs | 24 hours post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sibtain Anwar, MA MB FRCA | Barts and The London NHS Trust | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain and Ananesthesia Research Centre, Barts and The London NHS Trust | London | EC1A 7BE | United Kingdom |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D006930 | Hyperalgesia |
| D002908 | Chronic Disease |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020886 | Somatosensory Disorders |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Ketamine infusion | Drug | 0.1mg/kg/hr for 48 hours post operatively |
|
| Placebo capsules | Drug | 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 | Drug | Normal saline placebo intravenous infusion for 48 hours |
|
| Sedation (including pCO2) and nausea scores at 24 hours post surgery | 24 hours post surgery |
| Side effect episodes (dizziness, confusion, blurred vision) | First 48 hours |
| Time to extubation | Post op recovery period |
| Length of stay in intensive care and hospital | Post operative - acute |
| 28 day mortality | 28 days post surgery |
| Neuropathic pain score | S-LANSS (Short form Leeds Assessment of Neuropathic Symptoms and Signs) | 3 and 6 months post surgery |
| Quality of Life | EQ-5D validated scoring scale | 3 and 6 months |
| Survival | 3 and 6 months |
| QST measurements | Pain Pressure Thresholds (PPT) using algometry, both pre and post Diffuse Noxious Inhibitory Control (DNIC) Tactile and Pain Detection Thresholds with mechanical static stimulus using Von Frey hairs (VFH) Dynamic assessment of temporal summation and secondary hyeralgesia with VFH | Pre op and post op at 72hrs and 3 months |
| D012678 | Sensation Disorders |
| D009422 | Nervous System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |