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

Study Overview

• Status: Completed
• Conditions: Pain; Neuropathic Pain; Hyperalgesia; Chronic Illness
• Intervention / Treatment: Drug: Placebo capsules; Drug: Placebo infusion; Drug: Pregabalin; Drug: Ketamine infusion

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • Pain and Ananesthesia Research Centre, Barts and The London NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Placebo infusion; Normal saline placebo intravenous infusion for 48 hours; 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Neuropathic pain score	S-LANSS (Short form Leeds Assessment of Neuropathic Symptoms and Signs)	3 and 6 months post surgery
Quality of Life	EQ-5D validated scoring scale	3 and 6 months
Survival		3 and 6 months
QST measurements	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	Pre op and post op at 72hrs and 3 months

Collaborators and Investigators

• Sponsor: Barts & The London NHS Trust
• Investigators: Study Director: Sibtain Anwar, MA MB FRCA, Barts and the London NHS Trust

Study record dates

Study Major Dates

• Study Start: December 12, 2011
• Primary Completion (Actual): March 7, 2013
• Study Completion (Actual): March 7, 2013

Study Registration Dates

• First Submitted: November 24, 2011
• First Submitted That Met QC Criteria: November 24, 2011
• First Posted (Estimated): November 29, 2011

Study Record Updates

• Last Update Posted (Actual): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Neuromuscular Diseases; Disease Attributes; Peripheral Nervous System Diseases; Sensation Disorders; Somatosensory Disorders; Neuralgia; Hyperalgesia; Chronic Disease; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Neurotransmitter Agents; Membrane Transport Modulators; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anesthetics, Intravenous; Anesthetics, General; Anticonvulsants; Calcium Channel Blockers; Excitatory Amino Acid Agents; Anesthetics, Dissociative; Excitatory Amino Acid Antagonists; Pregabalin; Ketamine
• Other Study ID Numbers: Reda 007583; 2010-024462-21 (Registry Identifier: EudraCT); 11/H0703/7 (Registry Identifier: UK REC Ref)