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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-024462-21-GB

Enrollment

Unknown

Registered

2011-02-02

Start date

2011-04-26

Completion date

Unknown

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Lyrica Product Name: Pregabalin Pharmaceutical Form: Capsule* INN or Proposed INN: pregabalin Other descriptive name: lyrica Concentration unit: mg milligram(s) Concentration type: range C

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026