Condition category
Signs and Symptoms
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
06/07/2009
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 Simon Middleton

ORCID ID

Contact details

Deparment of General Surgery
Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0199192286

Study information

Scientific title

Acronym

Study hypothesis

Does the use of local anaesthetic nerve blocks to numb the operation site, once the patient is anaesthetised, reduce port operative pain in patients undergoing appendectomy? This will be compared to infiltration of the skin alone with local anaesthetic.

Ethics approval

Not provided at time of registration

Study design

Randomised prospective trial with patient and ward staff blinded to intervention

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Signs and Symptoms: Pain

Intervention

1. Group A: local infiltration of skin prior to incision with bupivacaine according to weight.
2. Group B: half the bupivacaine by weight infiltrated into the skin prior to incision. As incision deepened second half of bupivacaine given under direct vision deep to external oblique, lateral to the incision, to create field block.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Post operative pain in recovery: by questionnaire in recovery
2. Post operative pain on ward at 4 and 8 hours post op: by questionnaire
3. Post operative pain at 24 hours or at discharge, whichever is sooner.
4. Hours from operation to discharge.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

07/03/2007

Overall trial end date

30/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

All open appendectomies undertaken for acute appendicitis at Royal Berkshire Hospital. At time of analysis different sub groups formed according to operative findings: gangrenous / perforated appendix or normal appendix.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

90

Participant exclusion criteria

1. Laparoscopic appendectomies.
2. Appendix removed at time of planned laparotomy (i.e. not through small incision).

These exclusion criteria exist as we wish to judge the effect of local anaesthetic on post operative pain. Where a different size wound is left (laparoscopic or laparotomy) it would be an unfair comparison.
Where the initial operation is appendectomy via a lanz incision but an alternative pathology is found or the wound is extended for a laparotomy then the patient will be included in the study until the time of analysis.

Recruitment start date

07/03/2007

Recruitment end date

30/06/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Deparment of General Surgery
Reading
RG1 5AN
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

Royal Berkshire NHS Foundation Trust (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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19508549

Publication citations

  1. Results

    Randall JK, Goede A, Morgan-Warren P, Middleton SB, Randomized clinical trial of the influence of local subcutaneous infiltration vs subcutaneous and deep infiltration of local anaesthetic on pain after appendicectomy., Colorectal Dis, 2010, 12, 5, 477-479, doi: 10.1111/j.1463-1318.2009.01831.x.

Additional files

Editorial Notes