Preventing Pain After Heart Surgery

Pain Clinical Trial

Official title:

Prospective, Double-blinded, Randomised, Placebo Controlled Trial of Pre-emptive Analgesia to Prevent Pain Following Sternotomy for Cardiac Surgery.

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Illness
• Hyperalgesia
• Neuralgia
• Neuropathic Pain
• Pain

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