Paravertebral nerve blocks for analgesia after cardiac surgery

ISRCTN	ISRCTN13424423
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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Dr Geoff Lockwood
Public

Hammersmith Hospital
London
W12 0HS
United Kingdom

ORCID ID	0000-0003-3180-5824

Study information

Study design	Single centre interventional randomised controlled trial
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
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

Hammersmith Hospital

Ducane Road
London
W12 0HS
United Kingdom

Sponsor information

Imperial College Healthcare
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
Email	becky.ward@imperial.ac.uk
Website	www.ic.ac.uk/clinicalresearchgovernanceoffice
"ROR"	https://ror.org/056ffv270

Funders

Funder type

Hospital/treatment centre

Imperial College Healthcare NHS Trust
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
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?
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