ISRCTN - ISRCTN13424423: Paravertebral nerve blocks for analgesia after cardiac surgery

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Dr Geoff Lockwood

ORCID ID

http://orcid.org/0000-0003-3180-5824

Contact details

Hammersmith Hospital
London
W12 0HS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13HH1841

Study information

Scientific title

A double blind, randomised controlled trial to assess the efficacy of bilateral paravertebral blockade for analgesia after cardiac surgery

Acronym

Study hypothesis

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

London (Dulwich), 08/08/2014, ref: 14/LO/0864

Study design

Single centre interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Postoperative pain

Intervention

Bilateral paravertebral blockade or sham infusion of lidocaine

Intervention type

Procedure/Surgery

Phase

Drug names

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 trial start date

06/09/2013

Overall trial end date

14/09/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age 40-70 years
2. Undergoing elective and urgent first time coronary bypass surgery

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

50

Participant 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

Recruitment start date

26/10/2014

Recruitment end date

07/09/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hammersmith Hospital
Ducane Road
London
W12 0HS
United Kingdom

Sponsor information

Organisation

Imperial College Healthcare

Sponsor type

Hospital/treatment centre

Website

www.ic.ac.uk/clinicalresearchgovernanceoffice

Funders

Funder type