Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
20/12/2013
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

Mr S Patil

ORCID ID

Contact details

Ward 34
The James Cook University Hospital
Marton Road
Cleveland
TS4 3BW
United Kingdom
+44 (0)1642 850 850
spatil@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0227170359

Study information

Scientific title

Acronym

Study hypothesis

Is there any difference in the results of two techniques of local anaesthetic blocks in carpal tunnel surgery with regards to pain during infiltration of the anaesthetic, adequacy of the anaesthesia and duration of anaesthesia?

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

Not specified

Trial type

Treatment

Patient information sheet

Condition

Carpal tunnel decompression

Intervention

20 patients with bilateral carpal tunnel syndromes would be recruited. Each patient would have one side operated in one setting. The other side would be operated in the next 4-6 weeks. Each patient would have a local anaesthetic block using one technique on one side and the other technique on the other side.
The first technique would involve infiltrating the operative site (skin and subcutaneous tissue) with 6ml of 2% lignocaine with a no. 23 needle.
The other technique would involve infiltration of 2.5ml of 2% lignocaine into the carpal tunnel followed by infiltration of the remaining 3.5ml into the skin and subcutaneous tissue at the site of the incision. The patient would be unaware of the technique used. The patient would be asked to score the pain felt during the administration of the local anaesthetic block using a verbal pain score. The time taken for complete anaesthesia over the site of the incision would be noted. All the operations would be performed by one of the two surgeons in the trial using a standardised technique. It the patient experiences any pain during the operation, this would be recorded using a verbal pain score. Additional anaesthetic would be administered if needed. The duration of the operation and the tourniquet time would also be noted. These patients would be contacted by telephone the next day and asked about the need of analgesics postoperatively over a period of 24 hours and the pain scores at 0, 2 and 4 hours postoperatively.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

1. Pain during the operation
2. Pain during the administration of the local anaesthetic block
3. Frequency of post operative analgesics needed

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2005

Overall trial end date

05/07/2006

Reason abandoned

Eligibility

Participant inclusion criteria

20 patients - calculated by Dr Arts - statistician at Durham University. Inclusion criteria: all patients with bilateral carpal tunnel syndrome who would need surgical decompression.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

1. Re-do carpal tunnel decompressions
2. Carpal tunnel decompressions requiring general anaesthetic
3. Peripheral neuropathy, vascular insufficiency

Recruitment start date

01/06/2005

Recruitment end date

05/07/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ward 34
Cleveland
TS4 3BW
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 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

South Tees Hospitals NHS Trust

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

2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/17046117

Publication citations

  1. Results

    Patil S, Ramakrishnan M, Stothard J, Local anaesthesia for carpal tunnel decompression: a comparison of two techniques., J Hand Surg Br, 2006, 31, 6, 683-686, doi: 10.1016/j.jhsb.2006.08.008.

Additional files

Editorial Notes