Pain Clinical Trial
Official title:
Prospective, Double-blinded, Randomised, Placebo Controlled Trial of Pre-emptive Analgesia to Prevent Pain Following Sternotomy for Cardiac Surgery.
The use of pre-emptive analgesia to prevent pain following sternotomy for cardiac surgery
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Informed Consent - First time sternotomy for all cardiac surgery - Patient aged 18 - 80 years Exclusion Criteria: - Emergency surgery (decision to operate taken on the day of surgery) - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United Kingdom | Pain and Ananesthesia Research Centre, Barts and The London NHS Trust | London |
Lead Sponsor | Collaborator |
---|---|
Barts & The London NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Total morphine consumption at 24 hours post surgery | 24 hours post surgery | Yes | |
Secondary | Visual Analogue Scale (VAS) scores at 24 hrs post surgery, at rest and following 3 maximal coughs | 24 hours post surgery | No | |
Secondary | Sedation (including pCO2) and nausea scores at 24 hours post surgery | 24 hours post surgery | Yes | |
Secondary | Side effect episodes (dizziness, confusion, blurred vision) | First 48 hours | Yes | |
Secondary | Time to extubation | Post op recovery period | No | |
Secondary | Length of stay in intensive care and hospital | Post operative - acute | No | |
Secondary | 28 day mortality | 28 days post surgery | No | |
Secondary | Neuropathic pain score | S-LANSS (Short form Leeds Assessment of Neuropathic Symptoms and Signs) | 3 and 6 months post surgery | No |
Secondary | Quality of Life | EQ-5D validated scoring scale | 3 and 6 months | No |
Secondary | Survival | 3 and 6 months | No | |
Secondary | 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 | No |
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