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

November 24, 2011
November 11, 2012
November 2011
August 2013   (final data collection date for primary outcome measure)
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 ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01480765 on ClinicalTrials.gov Archive Site
  • 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
  • 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 and nausea scores at 6 hours post surgery [ Time Frame: 6 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 at 3 months [ Time Frame: 3 month spost surgery ] [ Designated as safety issue: No ]
    S-LANSS (Short form Leeds Assessment of Neuropathic Symptoms and Signs)
  • Quality of Life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    EQ-5D validated scoring scale
  • Survival [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Preventing Pain After Heart Surgery
Prospective, Double-blinded, Randomised, Placebo Controlled Trial of Pre-emptive Analgesia to Prevent Pain Following Sternotomy for Cardiac Surgery.

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Pain
  • Hyperalgesia
  • Chronic Illness
  • Neuropathic Pain
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
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
United Kingdom
 
NCT01480765
Reda 007583, 2010-024462-21, 11/H0703/7
Yes
Barts & The London NHS Trust
Barts & The London NHS Trust
Not Provided
Study Director: Sibtain Anwar, MA MB FRCA Barts and The London NHS Trust
Barts & The London NHS Trust
May 2012

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