Paravertebral nerve blocks for analgesia after cardiac surgery
ISRCTN | ISRCTN13424423 |
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DOI | https://doi.org/10.1186/ISRCTN13424423 |
Secondary identifying numbers | 13HH1841 |
- Submission date
- 10/07/2015
- Registration date
- 26/07/2015
- Last edited
- 09/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
The aim of this study is to find out whether injecting a local anaesthetic into the back to block the nerves to the chest (a paravertebral injection) reduces pain after cardiac surgery. This is a technique of pain control the trialistshave been using recently and it sounds sensible, but it’s hard to be sure that it really works because there are such big differences in the amount of pain people experience after cardiac surgery. What’s more, just getting local anaesthetics into the blood stream reduces pain after other surgical operations, so it may be that paravertebral injections are working simply because the drug is being absorbed into the blood. This study is designed to clarify the situation.
Who can participate?
Patients undergoing coronary artery bypass grafting.
What does the study involve?
Patients are randomly allocated into one of two groups. Those in group 1 are given bilateral paravertebral blocks during surgery. Those in group 2 are given a dummy, or 'sham', injection under the skin. After surgery, patients are able to self-administer pain relief (morphine) as they need it, to see whether the patients with true paravertebral injections want less morphine than those with the sham injections.
What are the possible benefits and risks of participating?
It is hoped that all patients taking part get additional benefit from the local anaesthetic infusion. The catheters are placed under the same rigorous aseptic conditions as the rest of their surgery so no infections are expected.
Where is the study run from?
Hammersmith Hospital (UK)
When is study starting and how long is it expected to run for?
October 2014 to September 2016
Who is funding the study?
Imperial College Healthcare NHS Trust (UK)
Who is the main contact?
Dr Geoff Lockwood
g.lockwood@imperial.ac.uk
Contact information
Public
Hammersmith Hospital
London
W12 0HS
United Kingdom
0000-0003-3180-5824 |
Study information
Study design | Single centre interventional randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
Scientific title | A double blind, randomised controlled trial to assess the efficacy of bilateral paravertebral blockade for analgesia after cardiac surgery |
Study objectives | Do paravertebral blocks provide useful analgesia by blocking specific nerves or are we simply seeing the systemic effects of the local anaesthetics as they are absorbed into the circulation? |
Ethics approval(s) | London (Dulwich), 08/08/2014, ref: 14/LO/0864 |
Health condition(s) or problem(s) studied | Postoperative pain |
Intervention | Bilateral paravertebral blockade or sham infusion of lidocaine |
Intervention type | Procedure/Surgery |
Primary outcome measure | Morphine consumption using a PCA device |
Secondary outcome measures | 1. Pain (measured using ordinal scale) and respiratory function (PEFR) for first 7 days 2. Quality of life, measured using the EuroQol EQ-5D questionnaire at 3 months |
Overall study start date | 06/09/2013 |
Completion date | 14/09/2016 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 50 |
Key inclusion criteria | 1. Age 40-70 years 2. Undergoing elective and urgent first time coronary bypass surgery |
Key exclusion criteria | 1. Critical preoperative state 2. Single graft surgery (no leg incision) 3. Minimally invasive surgery (no sternotomy) 4. Significant renal disease (baseline creatinine >150 micromolar: morphine contraindicated) 5. Patients exceeding 110kg (4% of our operative population practical difficulties of positioning unconscious patients to place the block) 6. Pregnancy 7. Patients with chronic pain taking regular analgesic medication 8. Patients with a significant abnormality of coagulation 9. Participation in another interventional study 10. Patients unable to give informed consent 11. Hypersensitivity to lidocaine |
Date of first enrolment | 26/10/2014 |
Date of final enrolment | 07/09/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
W12 0HS
United Kingdom
Sponsor information
Hospital/treatment centre
Joint Research Compliance Office
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
England
United Kingdom
Phone | +44 (0)20 3311 0205 |
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becky.ward@imperial.ac.uk | |
Website | www.ic.ac.uk/clinicalresearchgovernanceoffice |
https://ror.org/056ffv270 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Imperial NHS, imperialnhs, Imperial College Healthcare NHS Trust | London
- Location
- United Kingdom
Results and Publications
Intention to publish date | 30/03/2016 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | Peer-reviewed journal |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/10/2017 | Yes | No | |
HRA research summary | 26/07/2023 | No | No |
Editorial Notes
09/06/2017: Publication reference added.
09/09/2016: Changed overall end date to 14/09/2016. Changed recruitment end date to 07/09/2016
11/08/2016: Changed recruitment end date from 26/10/2015 to 26/10/2016