Condition category
Surgery
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
14/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ganesh Gopalakrishnan

ORCID ID

Contact details

42 Blackburn Avenue
Brough
HU15 1BD
United Kingdom
+44 07766462429
drganesh_2000@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0084186835

Study information

Scientific title

Comparison of Stimulating versus Non-stimulating catheter technique for Continuous Interscalene Brachial Plexus block by Posterior approach for shoulder surgery

Acronym

Study hypothesis

Limb surgeries can cause considerable pain after the operation. One of the most effective methods of relieving this pain is to use a procedure called Nerve Plexus Block, which numbs the nerves carrying pain sensation from the operation site. To provide pain relief continuously for next few days, catheters (small plastic tube) are inserted close to the nerves whilst doing the block and left in place, so that local anaesthetic can be delivered through it continuously. In order to identify nerves we use nerve stimulators. When needle is accurately located, we put in the catheter through the needle. There are two types of catheters:
1. Continuous stimulating catheter where it has the advantage of having nerve stimulating facilities which helps to make sure catheter is still in the right place
2. Continuous non-stimulating catheter which is exactly the same as above without nerve stimulating facility.

The purpose of this study is to compare the two types of catheters when used for nerve plexus block for shoulder surgeries with respect to ease of catheter placement, onset of block and efficacy of pain relief.

Ethics approval

Not provided at time of registration

Study design

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 the contact details below to request a patient information sheet

Condition

Surgery: Shoulder

Intervention

Introduction:
Continuous Interscalene nerve plexus block is a pain relief technique offered to all patients coming for shoulder surgeries as a routine. It involves identifying and numbing the nerves conveying pain sensation from shoulder. This is provided continuously by placing a catheter.

The purpose of this study is to:
Compare Stimulating and Non-Stimulating catheter technique for continuous ISB (interscalene nerve block) posterior approach for shoulder surgeries in terms of their catheter placement time, efficacy, onset of block, post op pain score, primary (during the operation) and secondary (after the operation) pain relief failure rate, patient satisfaction and catheter compliance.

Those enrolled in the study would be patients coming for elective shoulder surgeries in the orthopaedic list at Castle Hill hospital. Patients would be admitted the day before surgery, pre-assessed, given information regarding this study and screened whether they full fill the criteria. If they are happy to participate in the study, they would be consented.

Methodology:
This study would be prospective, randomised and single blinded. Randomisation would be computer generated. Once patients satisfy criteria informed consent would be obtained during pre-assessment, the day before the operation. Randomisation would be to one of the two groups:
1. Group A = Non-stimulating catheter for continuous ISB
2. Group B = Stimulating Catheter for Continuous ISB
The patient would come with a sealed envelope to the anaesthetic room and the procedure would be depending on the technique mentioned in the envelope.

Outcome measures:
Catheter placement time (from the time needle to the skin to application of sticky plaster), and ease of placement would be noted.
Sensory and Motor block would be assessed at 5, 10, 15, 20, 30 minutes and time zero would be designated at the end of local anaesthetic injection. Before surgery, a separate investigator would assess the block.
Post-operative:
Assessment of pain scores at rest will be done using Verbal Rating Score graded from 0 (no pain) to 4 (worst imaginable pain) for as long as catheter is required post op (would be done by different person blinded to the technique).
Patient satisfaction score with respect to catheter placement would be graded as excellent, good, poor or unsatisfactory.

Care for patients in both groups will be identical.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

1. Catheter placement time (time from insertion of needle to applying sticky plaster)
2. Onset of sensory and motor blockade (time from LA injection to Block of all dermatomes)
3. Efficacy of analgesia (intra op analgesic needed, Post op VAS scores and post op LA required and Opiates needed)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

28/09/2006

Overall trial end date

31/07/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients 18 years & over for elective shoulder surgery
2. ASA 1 and 2 patients.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Total of 80 patients divided into two equal groups.

Participant exclusion criteria

1. ASA 3 & 4 patients
2. Patients on anticoagulants
3. Allergic to local anaesthetic
5. Known neurological damage to the concerned limb

Recruitment start date

28/09/2006

Recruitment end date

31/07/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

42 Blackburn Avenue
Brough
HU15 1BD
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

The North and South Bank Research and Development Consortium (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Hull & East Yorkshire Hospitals NHS Trust (Endowment Fund) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

No publication intended as of 05/04/2012

Publication citations

Additional files

Editorial Notes