Contact information
Type
Scientific
Primary contact
Mr Muhammed Rafay Sameem Siddiqui
ORCID ID
Contact details
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2HE
United Kingdom
+44 (0)7890 726471
Mohammed.Siddiqui@wash.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A double blind, randomised, placebo-controlled trial investigating the use of levobupivicaine transversus abdominis blocks for colorectal laparoscopic surgery
Acronym
WORTHINGTAPTRIALUK
Study hypothesis
There is no difference in post-operative morphine requirements between patients receiving a transversus abdominis plane block versus placebo in elective laparoscopic colorectal surgery.
Ethics approval
West Sussex Ethics Council, pending approval as of 28/10/2008
Study design
Randomised, double blind (subject, surgeon, anaesthetist, investigator, outcomes assessor), placebo controlled, parallel assignment 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 for colorectal diseases
Intervention
1. Intervention group: transversus abdominis plane block (TAPB)
The skin will be prepared with 0.5% chlorhexidine solution spray in 70% v/v BEB. A high frequency (5 - 10 MHz) ultrasound machine (Titan Sonosite, Sonosite Inc, serial number 036CGP) which conforms to EN60601-1 will be placed in the region of the triangle of Petit whose boundaries are the latissimus dorsi, external oblique muscles and the anterior superior iliac spine. This delineates all three layers of the anterior abdominal wall. Placing a 4 inch 21G needle (Stimuplex A insulated needle CE 0123, B Braun) perpendicular to the anterior abdominal wall the ultrasound will be used to guide the appropriate point of skin puncture. Once in the correct plane between transversus abdominis and internal oblique a 20 ml syringe (Becton-Dickinson - Plastipak syringe) with 0.25% - 0.5% Chirocaine® (levobupivicaine) infiltrated bilaterally to a total of 40 ml of 0.25% - 0.5% Chirocaine® will be attached to the plastic tubing extending from the needle and infused feeling for resistance and watching for inappropriate infusion. This will be repeated on the other side and the formal surgery commences.
2. Placebo group: standard care
A similar technique is used to the one described above using 20 ml of normal 0.9% saline. A standard general anaesthetic will be used (to discuss with anaesthetists), regular post-operative analgesia in terms of paracetamol orally 1 g four times daily (qds) and diclofenac 50 mg three times daily (tds) will be given. In addition a patient-controlled analgesia (PCA) will be used with 1 mg boluses, 5 minute lockouts and a maximum of 10 mg an hour.
All patients stayed in post-anaesthetic care unit (PACU) for 1 hour and then moved to the ward unless otherwise indicated.
Intervention type
Drug
Phase
Not Specified
Drug names
Levobupivicaine (Chirocaine®), paracetamol, diclofenac
Primary outcome measures
Post-operative morphine requirement measured in mg via a patient controlled system and analysed according to mg/kg, assessed according to usage at 1, 12, 24 and 48 hours after the patient wakes up from the anaesthetic.
Secondary outcome measures
1. Total hospital stay (MM), documented at discharge
2. Pain scores on a visual analogue scale (VAS) and categorical scoring system at rest and on movement (defined as going from a supine to sitting position) or coughing. VAS pain scores and categorical scoring system scores will be taken at 1, 12, 24 and 48 hours after the patient wakes, and upon waking up on PACU.
3. Time to first analgesia bolus, documented on the PCA pump
Overall trial start date
01/02/2009
Overall trial end date
01/08/2009
Reason abandoned
Hypothesis significantly changed
Eligibility
Participant inclusion criteria
1. Men and women, over the age of 18 years
2. Receiving any type of elective, laparoscopic colorectal surgery for benign or malignant disease
3. Operations conducted at Worthing Hospital, West Sussex, by any of the colorectal surgeons
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Patients under the age of 18 years
2. Undergoing open or emergency surgery
3. A history of renal failure, coagulopathies or allergy to levobupivicaine
4. Reoperations for complications
5. Previous abdominal surgery
6. Not undergoing colorectal surgery
7. Patients in which an intentional stoma is to be fashioned
8. Refusal to participate
Recruitment start date
01/02/2009
Recruitment end date
01/08/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Worthing Hospital
Worthing
BN11 2HE
United Kingdom
Sponsor information
Organisation
Worthing and Southlands Hospitals NHS Trust (UK)
Sponsor details
c/o Mr Mirza Baig
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2NE
United Kingdom
+44 (0)1903 205111
Mirza.Baig@wash.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Worthing and Southlands Hospitals NHS Trust (UK) - Worthing Research Unit
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