Skip to main content
OpenTrials
Completed

NCT Number: NCT01480765

Preventing Pain After Heart Surgery

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Chronic Disease Chronic Illness Disease Attributes Hyperalgesia Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pain and Ananesthesia Research Centre, Barts and The London NHS Trust

London, EC1A 7BE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Total morphine consumption at 24 hours post surgery

    Time frame: 24 hours post surgery

  2. Visual Analogue Scale (VAS) scores at 24 hrs post surgery, at rest and following 3 maximal coughs

    Time frame: 24 hours post surgery

  3. Sedation (including pCO2) and nausea scores at 24 hours post surgery

    Time frame: 24 hours post surgery

  4. Side effect episodes (dizziness, confusion, blurred vision)

    Time frame: First 48 hours

  5. Time to extubation

    Time frame: Post op recovery period

  6. Length of stay in intensive care and hospital

    Time frame: Post operative - acute

  7. 28 day mortality

    Time frame: 28 days post surgery

  8. Neuropathic pain score

    Time frame: 3 and 6 months post surgery

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

  9. Quality of Life

    Time frame: 3 and 6 months

    EQ-5D validated scoring scale

  10. Survival

    Time frame: 3 and 6 months

  11. 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

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 29, 2011
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.