Condition category
Signs and Symptoms
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In one sentence, the purpose 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 we have 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, we know that just getting local anaesthetics into the blood stream reduces pain after other surgical operations, so it may be that our paravertebral injections are working simply because the drug is being absorbed into the blood. This trial is designed to clarify the situation.

Who can participate?
Patients undergoing coronary artery bypass grafting.

What does the study involve?
Patients are randomly allocated intone 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. We will 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?
We hope that all patients taking part will 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 we expect no infections.

Where is the study run from?
Hammersmith Hospital, London (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

Who is the main contact?
Dr Geoff Lockwood

Trial website

Contact information



Primary contact

Dr Geoff Lockwood


Contact details

Hammersmith Hospital
W12 0HS
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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


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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Postoperative pain


Bilateral paravertebral blockade or sham infusion of lidocaine

Intervention type



Drug names

Primary outcome measures

Morphine consumption using a PCA device

Secondary outcome measures

1. Pain (ordinal scale) and respiratory function (PEFR) for first 7 days
2. Quality of life questionnaire at 3 months (EuroQol EQ-5D)

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

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

Participant type


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Hammersmith Hospital
Ducane Road
W12 0HS
United Kingdom

Sponsor information


Imperial College Healthcare

Sponsor details

Joint Research Compliance Office
Charing Cross Hospital
Fulham Palace Road
W6 8RF
United Kingdom
+44 (0)20 3311 0205

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

Imperial College Healthcare NHS Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


United Kingdom

Results and Publications

Publication and dissemination plan

Peer-reviewed journal

Intention to publish date


Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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