Preventing Pain After Heart Surgery

Ketamine

Brief Summary

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

Intervention / Treatment

  • Pregabalin (DRUG)
    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 (DRUG)
    0.1mg/kg/hr for 48 hours post operatively
  • Placebo capsules (DRUG)
    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 (DRUG)
    Normal saline placebo intravenous infusion for 48 hours

Condition or Disease

  • Pain
  • Hyperalgesia
  • Chronic Illness
  • Neuropathic Pain

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 18 Years to 80 Years
    Enrollment: 150 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Nov 01, 2011
    Primary Completion: Aug 01, 2013 ESTIMATED
    Completion Date: Dec 01, 2013 ESTIMATED
    Study First Posted: Nov 29, 2011 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Nov 11, 2012

    Sponsors / Collaborators

    Lead Sponsor: Barts & The London NHS Trust
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    London, England, United Kingdom

    Participant Groups

    • Placebo capsules and Placebo infusion

    • Pregabalin capsules and Placebo infusion

    • Pregabalin capsules + Ketamine infusion

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 80
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • 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
    Secondary Outcomes
    • Total morphine consumption at 24 hours post surgery 24 hours post surgery
    • Visual Analogue Scale (VAS) scores at 24 hrs post surgery, at rest and following 3 maximal coughs 24 hours post surgery
    • Sedation (including pCO2) and nausea scores at 24 hours post surgery 24 hours post surgery
    • Side effect episodes (dizziness, confusion, blurred vision) First 48 hours
    • Time to extubation Post op recovery period
    • Length of stay in intensive care and hospital Post operative - acute
    • 28 day mortality 28 days post surgery

    • S-LANSS (Short form Leeds Assessment of Neuropathic Symptoms and Signs)

    • EQ-5D validated scoring scale

    • Survival 3 and 6 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

    More Details

    NCT Number: NCT01480765
    Other IDs: Reda 007583
    Study URL: https://clinicaltrials.gov/study/NCT01480765
    Last updated: Sep 29, 2023