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Preventing Pain After Heart Surgery

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ClinicalTrials.gov Identifier: NCT01480765
Recruitment Status : Unknown
Verified May 2012 by Barts & The London NHS Trust.
Recruitment status was:  Recruiting
First Posted : November 29, 2011
Last Update Posted : November 14, 2012
Sponsor:
Information provided by (Responsible Party):
Barts & The London NHS Trust

Tracking Information
First Submitted Date  ICMJE November 24, 2011
First Posted Date  ICMJE November 29, 2011
Last Update Posted Date November 14, 2012
Study Start Date  ICMJE November 2011
Estimated Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2012)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 24, 2011)
Numerical Rating Scale (NRS) pain score (around sternotomy incision site) at 3 months post surgery, at rest and following 3 maximal coughs. [ Time Frame: 3 months post sternotomy ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2012)
  • Total morphine consumption at 24 hours post surgery [ Time Frame: 24 hours post surgery ]
  • Visual Analogue Scale (VAS) scores at 24 hrs post surgery, at rest and following 3 maximal coughs [ Time Frame: 24 hours post surgery ]
  • Sedation (including pCO2) and nausea scores at 24 hours post surgery [ Time Frame: 24 hours post surgery ]
  • Side effect episodes (dizziness, confusion, blurred vision) [ Time Frame: First 48 hours ]
  • Time to extubation [ Time Frame: Post op recovery period ]
  • Length of stay in intensive care and hospital [ Time Frame: Post operative - acute ]
  • 28 day mortality [ Time Frame: 28 days post surgery ]
  • Neuropathic pain score [ Time Frame: 3 and 6 months post surgery ]
    S-LANSS (Short form Leeds Assessment of Neuropathic Symptoms and Signs)
  • Quality of Life [ Time Frame: 3 and 6 months ]
    EQ-5D validated scoring scale
  • Survival [ Time Frame: 3 and 6 months ]
  • QST measurements [ Time Frame: Pre op and post op at 72hrs and 3 months ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2011)
  • Total morphine consumption at 24 hours post surgery [ Time Frame: 24 hours post surgery ]
  • Visual Analogue Scale (VAS) scores at 24 hrs post surgery, at rest and following 3 maximal coughs [ Time Frame: 24 hours post surgery ]
  • Sedation and nausea scores at 6 hours post surgery [ Time Frame: 6 hours post surgery ]
  • Side effect episodes (dizziness, confusion, blurred vision) [ Time Frame: First 48 hours ]
  • Time to extubation [ Time Frame: Post op recovery period ]
  • Length of stay in intensive care and hospital [ Time Frame: Post operative - acute ]
  • 28 day mortality [ Time Frame: 28 days post surgery ]
  • Neuropathic pain score at 3 months [ Time Frame: 3 month spost surgery ]
    S-LANSS (Short form Leeds Assessment of Neuropathic Symptoms and Signs)
  • Quality of Life [ Time Frame: 3 months ]
    EQ-5D validated scoring scale
  • Survival [ Time Frame: 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preventing Pain After Heart Surgery
Official Title  ICMJE Prospective, Double-blinded, Randomised, Placebo Controlled Trial of Pre-emptive Analgesia to Prevent Pain Following Sternotomy for Cardiac Surgery.
Brief Summary The use of pre-emptive analgesia to prevent pain following sternotomy for cardiac surgery
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Pain
  • Hyperalgesia
  • Chronic Illness
  • Neuropathic Pain
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Control: Placebo + Placebo
    Placebo capsules and Placebo infusion
    Interventions:
    • Drug: Placebo capsules
    • Drug: Placebo infusion
  • Active Comparator: Pregabalin and Placebo infusion
    Pregabalin capsules and Placebo infusion
    Interventions:
    • Drug: Pregabalin
    • Drug: Placebo infusion
  • Active Comparator: Pregabalin + Ketamine infusion
    Pregabalin capsules + Ketamine infusion
    Interventions:
    • Drug: Pregabalin
    • Drug: Ketamine infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 24, 2011)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01480765
Other Study ID Numbers  ICMJE Reda 007583
2010-024462-21 ( Registry Identifier: EudraCT )
11/H0703/7 ( Registry Identifier: UK REC Ref )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Barts & The London NHS Trust
Study Sponsor  ICMJE Barts & The London NHS Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sibtain Anwar, MA MB FRCA Barts and The London NHS Trust
PRS Account Barts & The London NHS Trust
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP