Preventing Pain After Heart Surgery

• Sponsor: Barts & The London NHS Trust (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01480765
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 3
• Duration (Months): 25
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain; Hyperalgesia; Chronic Illness; Neuropathic Pain	Drug: Pregabalin; Drug: Ketamine infusion; Drug: Placebo capsules; Drug: Placebo infusion	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Prospective, Double-blinded, Randomised, Placebo Controlled Trial of Pre-emptive Analgesia to Prevent Pain Following Sternotomy for Cardiac Surgery.
• Study Start Date: Nov 1, 2011
• Anticipated Primary Completion Date: Aug 1, 2013
• Anticipated Study Completion Date: Dec 1, 2013

Arms and Interventions

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: 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: Placebo infusion; Normal saline placebo intravenous infusion for 48 hours
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

Outcome Measures

Primary Outcome Measures

1. 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

1. Total morphine consumption at 24 hours post surgery [24 hours post surgery]

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

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

4. Side effect episodes (dizziness, confusion, blurred vision) [First 48 hours]

5. Time to extubation [Post op recovery period]

6. Length of stay in intensive care and hospital [Post operative - acute]

7. 28 day mortality [28 days post surgery]

8. Neuropathic pain score [3 and 6 months post surgery]

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

9. Quality of Life [3 and 6 months]

   EQ-5D validated scoring scale

10. Survival [3 and 6 months]

11. QST measurements [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pain and Ananesthesia Research Centre, Barts and The London NHS Trust	London		United Kingdom	EC1A 7BE

Sponsors and Collaborators

• Barts & The London NHS Trust

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Barts & The London NHS Trust
• ClinicalTrials.gov Identifier: NCT01480765
• Other Study ID Numbers: Reda 007583; 2010-024462-21; 11/H0703/7
• First Posted: Nov 29, 2011
• Last Update Posted: Nov 14, 2012
• Last Verified: May 1, 2012

• Additional relevant MeSH terms: Neuralgia; Hyperalgesia; Chronic Disease; Pregabalin; Ketamine

Study Results

No Results Posted as of Nov 14, 2012