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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01480765
Other study ID # Reda 007583
Secondary ID 2010-024462-2111
Status Recruiting
Phase Phase 4
First received November 24, 2011
Last updated November 11, 2012
Start date November 2011
Est. completion date December 2013

Study information

Verified date May 2012
Source Barts & The London NHS Trust
Contact Sibtain Anwar, MA MB FRCA
Phone +44 2034655361
Email sibtainanwar@bartshealth.nhs.uk
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Drug:
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

Locations

Country Name City State
United Kingdom Pain and Ananesthesia Research Centre, Barts and The London NHS Trust London

Sponsors (1)

Lead Sponsor Collaborator
Barts & The London NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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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