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Preventing Pain After Heart Surgery

This study is currently recruiting participants.
Verified May 2012 by Barts & The London NHS Trust
Sponsor:
Information provided by (Responsible Party):
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT01480765
First received: November 24, 2011
Last updated: November 11, 2012
Last verified: May 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Pain
Hyperalgesia
Chronic Illness
Neuropathic Pain
 Drug: Pregabalin
Drug: Ketamine infusion
Drug: Placebo capsules
Drug: Placebo infusion
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prospective, Double-blinded, Randomised, Placebo Controlled Trial of Pre-emptive Analgesia to Prevent Pain Following Sternotomy for Cardiac Surgery.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total morphine consumption at 24 hours post surgery [ Time Frame: 24 hours post surgery ] [ Designated as safety issue: Yes ]
  • Visual Analogue Scale (VAS) scores at 24 hrs post surgery, at rest and following 3 maximal coughs [ Time Frame: 24 hours post surgery ] [ Designated as safety issue: No ]
  • Sedation (including pCO2) and nausea scores at 24 hours post surgery [ Time Frame: 24 hours post surgery ] [ Designated as safety issue: Yes ]
  • Side effect episodes (dizziness, confusion, blurred vision) [ Time Frame: First 48 hours ] [ Designated as safety issue: Yes ]
  • Time to extubation [ Time Frame: Post op recovery period ] [ Designated as safety issue: No ]
  • Length of stay in intensive care and hospital [ Time Frame: Post operative - acute ] [ Designated as safety issue: No ]
  • 28 day mortality [ Time Frame: 28 days post surgery ] [ Designated as safety issue: No ]
  • Neuropathic pain score [ Time Frame: 3 and 6 months post surgery ] [ Designated as safety issue: No ]
    S-LANSS (Short form Leeds Assessment of Neuropathic Symptoms and Signs)

  • Quality of Life [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    EQ-5D validated scoring scale

  • Survival [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • QST measurements [ Time Frame: Pre op and post op at 72hrs and 3 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 150
Study Start Date: November 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control: Placebo + Placebo
Placebo capsules and Placebo infusion
 Drug: 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
Drug: Placebo infusion
Normal saline placebo intravenous infusion for 48 hours
Active Comparator: Pregabalin and Placebo infusion
Pregabalin capsules and Placebo infusion
 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
Drug: Placebo infusion
Normal saline placebo intravenous infusion for 48 hours
Active Comparator: Pregabalin + Ketamine infusion
Pregabalin capsules + Ketamine infusion
 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
Drug: Ketamine infusion
0.1mg/kg/hr for 48 hours post operatively

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01480765

Contacts
Contact: Sibtain Anwar, MA MB FRCA +44 2034655361 sibtainanwar@bartshealth.nhs.uk
Contact: Chhaya Sharma, MB BS FRCA +44 2034655361 chhaya.sharma@bartshealth.nhs.uk

Locations
United Kingdom
Pain and Ananesthesia Research Centre, Barts and The London NHS Trust Recruiting
London, United Kingdom, EC1A 7BE
Contact: Sibtain Anwar, MA MB FRCA     +442034655361     sibtain.anwar@bartshealth.nhs.uk    
Sub-Investigator: Sibtain Anwar, MA MB FRCA            
Principal Investigator: Richard Langford, FRCA            
Sub-Investigator: Chhaya Sharma, MB BS FRCA            
Sub-Investigator: Junia Rahman, MB BS FRCA            
Sponsors and Collaborators
Barts & The London NHS Trust
Investigators
Study Director: Sibtain Anwar, MA MB FRCA Barts and The London NHS Trust
  More Information

No publications provided

Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT01480765     History of Changes
Other Study ID Numbers: Reda 007583, 2010-024462-21, 11/H0703/7
Study First Received: November 24, 2011
Last Updated: November 11, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Chronic Disease
Hyperalgesia
Neuralgia
Disease Attributes
Pathologic Processes
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pain
Peripheral Nervous System Diseases
Neuromuscular Diseases
Ketamine
Pregabalin
 Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on May 22, 2013