Back to resultsPreventing Pain After Heart Surgery
Primary Purpose
Pain, Hyperalgesia, Chronic Illness
Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Pregabalin
Ketamine infusion
Placebo capsules
Placebo infusion
Sponsored by
About this trial
This is an interventional prevention trial for Pain
Eligibility Criteria
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
Sites / Locations
- Pain and Ananesthesia Research Centre, Barts and The London NHS TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Control: Placebo + Placebo
Pregabalin and Placebo infusion
Pregabalin + Ketamine infusion
Arm Description
Placebo capsules and Placebo infusion
Pregabalin capsules and Placebo infusion
Pregabalin capsules + Ketamine infusion
Outcomes
Primary Outcome Measures
Numerical Rating Scale (NRS) pain score (around sternotomy incision site) post surgery, at rest and following 3 maximal coughs.
Secondary Outcome Measures
Total morphine consumption at 24 hours post surgery
Visual Analogue Scale (VAS) scores at 24 hrs post surgery, at rest and following 3 maximal coughs
Sedation (including pCO2) and nausea scores at 24 hours post surgery
Side effect episodes (dizziness, confusion, blurred vision)
Time to extubation
Length of stay in intensive care and hospital
28 day mortality
Neuropathic pain score
S-LANSS (Short form Leeds Assessment of Neuropathic Symptoms and Signs)
Quality of Life
EQ-5D validated scoring scale
Survival
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
Full Information
NCT ID
NCT01480765
First Posted
November 24, 2011
Last Updated
November 11, 2012
Sponsor
Barts & The London NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT01480765
Brief Title
Preventing Pain After Heart Surgery
Official Title
Prospective, Double-blinded, Randomised, Placebo Controlled Trial of Pre-emptive Analgesia to Prevent Pain Following Sternotomy for Cardiac Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barts & The London NHS Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The use of pre-emptive analgesia to prevent pain following sternotomy for cardiac surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Hyperalgesia, Chronic Illness, Neuropathic Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control: Placebo + Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules and Placebo infusion
Arm Title
Pregabalin and Placebo infusion
Arm Type
Active Comparator
Arm Description
Pregabalin capsules and Placebo infusion
Arm Title
Pregabalin + Ketamine infusion
Arm Type
Active Comparator
Arm Description
Pregabalin capsules + Ketamine infusion
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Ketamine infusion
Intervention Description
0.1mg/kg/hr for 48 hours post operatively
Intervention Type
Drug
Intervention Name(s)
Placebo capsules
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo infusion
Intervention Description
Normal saline placebo intravenous infusion for 48 hours
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Total morphine consumption at 24 hours post surgery
Time Frame
24 hours post surgery
Title
Visual Analogue Scale (VAS) scores at 24 hrs post surgery, at rest and following 3 maximal coughs
Time Frame
24 hours post surgery
Title
Sedation (including pCO2) and nausea scores at 24 hours post surgery
Time Frame
24 hours post surgery
Title
Side effect episodes (dizziness, confusion, blurred vision)
Time Frame
First 48 hours
Title
Time to extubation
Time Frame
Post op recovery period
Title
Length of stay in intensive care and hospital
Time Frame
Post operative - acute
Title
28 day mortality
Time Frame
28 days post surgery
Title
Neuropathic pain score
Description
S-LANSS (Short form Leeds Assessment of Neuropathic Symptoms and Signs)
Time Frame
3 and 6 months post surgery
Title
Quality of Life
Description
EQ-5D validated scoring scale
Time Frame
3 and 6 months
Title
Survival
Time Frame
3 and 6 months
Title
QST measurements
Description
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
Time Frame
Pre op and post op at 72hrs and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sibtain Anwar, MA MB FRCA
Phone
+44 2034655361
Email
sibtainanwar@bartshealth.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Chhaya Sharma, MB BS FRCA
Phone
+44 2034655361
Email
chhaya.sharma@bartshealth.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sibtain Anwar, MA MB FRCA
Organizational Affiliation
Barts and The London NHS Trust
Official's Role
Study Director
Facility Information:
Facility Name
Pain and Ananesthesia Research Centre, Barts and The London NHS Trust
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sibtain Anwar, MA MB FRCA
Phone
+442034655361
Email
sibtain.anwar@bartshealth.nhs.uk
First Name & Middle Initial & Last Name & Degree
Sibtain Anwar, MA MB FRCA
First Name & Middle Initial & Last Name & Degree
Richard Langford, FRCA
First Name & Middle Initial & Last Name & Degree
Chhaya Sharma, MB BS FRCA
First Name & Middle Initial & Last Name & Degree
Junia Rahman, MB BS FRCA
12. IPD Sharing Statement
Learn more about this trial
Preventing Pain After Heart Surgery
We'll reach out to this number within 24 hrs