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
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
-
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.