Efficacy of local anaesthetic transversus abdominis plane (TAP) blocks in laparoscopic colorectal surgery

ISRCTN	ISRCTN22165762
DOI	https://doi.org/10.1186/ISRCTN22165762
Protocol serial number	N/A
Sponsor	Worthing and Southlands Hospitals NHS Trust (UK)
Funder	Worthing and Southlands Hospitals NHS Trust (UK) - Worthing Research Unit

Submission date: 27/10/2008
Registration date: 04/11/2008
Last edited: 04/02/2011

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Muhammed Rafay Sameem Siddiqui
Scientific

Worthing Hospital
Lyndhurst Road
Worthing
BN11 2HE
United Kingdom

Phone	+44 (0)7890 726471
Email	Mohammed.Siddiqui@wash.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised, double blind (subject, surgeon, anaesthetist, investigator, outcomes assessor), placebo controlled, parallel assignment trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A double blind, randomised, placebo-controlled trial investigating the use of levobupivicaine transversus abdominis blocks for colorectal laparoscopic surgery
Study acronym	WORTHINGTAPTRIALUK
Study objectives	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(s)	West Sussex Ethics Council, pending approval as of 28/10/2008
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Levobupivicaine (Chirocaine®), paracetamol, diclofenac
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/08/2009
Reason abandoned (if study stopped)	Hypothesis significantly changed

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Key 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
Key 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
Date of first enrolment	01/02/2009
Date of final enrolment	01/08/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Worthing Hospital

Worthing
BN11 2HE
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes