Pain, Hyperalgesia, Chronic Illness, Neuropathic Pain
Conditions
Brief summary
The use of pre-emptive analgesia to prevent pain following sternotomy for cardiac surgery
Interventions
DRUGPregabalin
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
0.1mg/kg/hr for 48 hours post operatively
DRUGPlacebo 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
DRUGPlacebo infusion
Normal saline placebo intravenous infusion for 48 hours
Sponsors
Barts & The London NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) scores at 24 hrs post surgery, at rest and following 3 maximal coughs | 24 hours post surgery | — |
| 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 | — |
| Total morphine consumption at 24 hours post surgery | 24 hours post surgery | — |
| Neuropathic pain score | 3 and 6 months post surgery | S-LANSS (Short form Leeds Assessment of Neuropathic Symptoms and Signs) |
| Quality of Life | 3 and 6 months | EQ-5D validated scoring scale |
| Survival | 3 and 6 months | — |
| QST measurements | Pre op and post op at 72hrs and 3 months | 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 |
| 28 day mortality | 28 days post surgery | — |
Countries
United Kingdom
Outcome results
None listed