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

ISRCTN ISRCTN22165762
DOI https://doi.org/10.1186/ISRCTN22165762
Secondary identifying numbers N/A
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

Study designRandomised, double blind (subject, surgeon, anaesthetist, investigator, outcomes assessor), placebo controlled, parallel assignment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA double blind, randomised, placebo-controlled trial investigating the use of levobupivicaine transversus abdominis blocks for colorectal laparoscopic surgery
Study acronymWORTHINGTAPTRIALUK
Study objectivesThere 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) studiedSurgery for colorectal diseases
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Levobupivicaine (Chirocaine®), paracetamol, diclofenac
Primary outcome measurePost-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 measures1. 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 study start date01/02/2009
Completion date01/08/2009
Reason abandoned (if study stopped)Hypothesis significantly changed

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants100
Key inclusion criteria1. 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 criteria1. 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 enrolment01/02/2009
Date of final enrolment01/08/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Worthing Hospital
Worthing
BN11 2HE
United Kingdom

Sponsor information

Worthing and Southlands Hospitals NHS Trust (UK)
Hospital/treatment centre

c/o Mr Mirza Baig
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2NE
England
United Kingdom

Phone +44 (0)1903 205111
Email Mirza.Baig@wash.nhs.uk
Website http://www.worthinghospital.nhs.uk/

Funders

Funder type

Government

Worthing and Southlands Hospitals NHS Trust (UK) - Worthing Research Unit

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan