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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 24, 2011

Last Updated Date

November 11, 2012

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT01480765 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Preventing Pain After Heart Surgery

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Pain
Hyperalgesia
Chronic Illness
Neuropathic Pain

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

December 2013

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01480765

Other Study ID Numbers ^ICMJE

Reda 007583, 2010-024462-21, 11/H0703/7

Has Data Monitoring Committee

Yes

Responsible Party

Barts & The London NHS Trust

Study Sponsor ^ICMJE

Barts & The London NHS Trust

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Sibtain Anwar, MA MB FRCA

Barts and The London NHS Trust

Information Provided By

Barts & The London NHS Trust

Verification Date

May 2012

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

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