Preventing Pain After Heart Surgery

Phase 4CompletedNCT01480765

Barts & The London NHS Trust150 enrolled

Overview

The use of pre-emptive analgesia to prevent pain following sternotomy for cardiac surgery

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

150

Conditions

Pain Hyperalgesia Chronic Illness Neuropathic Pain

Interventions

PregabalinDRUG

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 infusionDRUG

0.1mg/kg/hr for 48 hours post operatively

Placebo capsulesDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Pain and Ananesthesia Research Centre, Barts and The London NHS Trust

London, United Kingdom

Outcomes

Primary Outcomes

Numerical Rating Scale (NRS) pain score (around sternotomy incision site) post surgery, at rest and following 3 maximal coughs.

Time frame: 3 and 6 months post sternotomy

Secondary Outcomes

Total morphine consumption at 24 hours post surgery

Time frame: 24 hours post surgery

Visual Analogue Scale (VAS) scores at 24 hrs post surgery, at rest and following 3 maximal coughs

Time frame: 24 hours post surgery

Sedation (including pCO2) and nausea scores at 24 hours post surgery

Time frame: 24 hours post surgery

Side effect episodes (dizziness, confusion, blurred vision)

Time frame: First 48 hours

Time to extubation

Time frame: Post op recovery period

Length of stay in intensive care and hospital

Time frame: Post operative - acute

28 day mortality

Time frame: 28 days post surgery

Neuropathic pain score

S-LANSS (Short form Leeds Assessment of Neuropathic Symptoms and Signs)

Time frame: 3 and 6 months post surgery

Quality of Life

EQ-5D validated scoring scale

Time frame: 3 and 6 months

Data from ClinicalTrials.gov

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