Condition category
Surgery
Date applied
27/10/2008
Date assigned
04/11/2008
Last edited
04/02/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.worthinghospital.nhs.uk/

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

Publication citations

Additional files

Editorial Notes