Prospective, double-blinded, randomised, placebo controlled trial of pre-emptive analgesia to prevent pain following sternotomy for cardiac surgery. - Preventing Pain After Heart Surgery. Version 2.0

Phase 1

• Conditions: Chronic pain in the chest incision site (sternotomy) after cardiac surgery

• Registration Number: EUCTR2010-024462-21-GB
• Lead Sponsor: Research and Development, Barts and The London NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-02
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Informed Consent
First time sternotomy for coronary artery bypass grafting (CABG)
Patient aged 18 - 80 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any inclusion criteria not met
Emergency surgery (decision to operate taken on the day of surgery)
Previous sternotomy
Preoperative renal failure (eGFR <60 ml/min)
Ejection fraction less than 50% on pre operative echocardiography
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.
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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The hypothesis to be tested is that the group receiving the medication will have a lower incidence of chronic pain at three months compared to the control group;Secondary Objective: Secondary measures will include effects of the medication on pain in the acute setting (at 6 and 12 hours after operation) as well as survival at 28 days and quality of life and satisfaction with pain relief at 3 months;Primary end point(s): Numerical Pain Score (around sternotomy incision site) at 3 months post surgery, at rest and following 3 maximal coughs.