Efficacy of local anaesthetic transversus abdominis plane (TAP) blocks in laparoscopic colorectal surgery
ISRCTN | ISRCTN22165762 |
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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
Scientific
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2HE
United Kingdom
Phone | +44 (0)7890 726471 |
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Mohammed.Siddiqui@wash.nhs.uk |
Study information
Study design | Randomised, double blind (subject, surgeon, anaesthetist, investigator, outcomes assessor), placebo controlled, parallel assignment trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Levobupivicaine (Chirocaine®), paracetamol, diclofenac |
Primary outcome measure | 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 study start date | 01/02/2009 |
Completion date | 01/08/2009 |
Reason abandoned (if study stopped) | Hypothesis significantly changed |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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
- England
- United Kingdom
Study participating centre
Worthing Hospital
Worthing
BN11 2HE
United Kingdom
BN11 2HE
United Kingdom
Sponsor information
Worthing and Southlands Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Mr Mirza Baig
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2NE
England
United Kingdom
Phone | +44 (0)1903 205111 |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |