The effect of an ilio-inguinal block in appendectomy on post operative pain and hospital stay

ISRCTN	ISRCTN05904043
DOI	https://doi.org/10.1186/ISRCTN05904043
Protocol serial number	N0199192286
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funder	Royal Berkshire NHS Foundation Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Simon Middleton
Scientific

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

Primary study design	Interventional
Study design	Randomised prospective trial with patient and ward staff blinded to intervention
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/06/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	90
Key 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.
Key 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.
Date of first enrolment	07/03/2007
Date of final enrolment	30/06/2007

Deparment of General Surgery

Reading
RG1 5AN
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2010		Yes	No