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11 February 2012
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| [ Print-friendly version ] |
| Transversus Abdominis Plane Block after laparoscopic live donor nephrectomy |
| ISRCTN | ISRCTN14709684 |
| ClinicalTrials.gov identifier | |
| Public title | Transversus Abdominis Plane Block after laparoscopic live donor nephrectomy |
| Scientific title | A randomised controlled trial of Transversus Abdominis Plane Block after laparoscopic live donor nephrectomy |
| Acronym | TAP Block Trial |
| Serial number at source | UHL 10883 |
| Study hypothesis | The hypothesis to be tested in this study is that the use of a transversus abdominis plane (TAP) block will reduce post-operative pain and analgesic requirements in patients undergoing laparoscopic live donor nephrectomy. |
| Lay summary | |
| Ethics approval | Leicestershire, Northamptonshire and Rutland Ethics Committee 1 approved on the 8th June 2010 (ref: 10/H0406/12) |
| Study design | Randomised single centre double-blinded placebo controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Post-operative pain |
| Participants - inclusion criteria |
Patients will be eligible for the trial if ALL of the following criteria are met:
1. Aged 18 years or over, either sex 2. American Society of Anaesthesiology (ASA) grade 1 or 2 3. Individuals who have completed the full work-up for laparoscopic donor nephrectomy, including an assessment by the Human Tissue Authority 4. Written, signed informed consent to the trial |
| Participants - exclusion criteria |
Patients will NOT be eligible for the trial if ANY of the following criteria apply:
1. A history of relevant drug allergy 2. Patients receiving medical therapies considered to result in tolerance to opioids 3. Any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study |
| Anticipated start date | 23/06/2010 |
| Anticipated end date | 23/06/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 50 |
| Interventions |
Patients will be randomised into one of two groups:
Group A: Bupivacaine local anaesthetic 20 ml 0.375% injected into the transversus abdominis plane at two sites before surgery Group B: Placebo control; normal saline 20 ml 0.9% injected into the transversus abdominis plane at two sites before surgery Follow up period of 7 days. |
| Primary outcome measure(s) |
1. Total post-operative morphine requirement: post-operative analgesic use will be recorded by the nursing staff and pain team using the standard PCAS form. This will include the total dose of morphine used in mg.
2. Daily post-operative pain levels recorded using visual analogue and verbal response scales: 100 mm line with no pain at all written at the left hand (zero) end and worst pain imaginable written at the right hand (100) end. 0 = no pain at rest or movement; 1 = no pain at rest, slight at movement; 2 = intermittent pain at rest, moderate on movement; 3 = continuous pain at rest and severe on movement. 3. Total duration of PCAS use: post-operative analgesic use will be recorded by the nursing staff and pain team using the standard PCAS from. This will include the duration of PCAS use in hours. |
| Secondary outcome measure(s) |
1. Daily post-operative nausea and vomiting recorded using visual analogue and verbal response scales. 0 = no nausea and vomiting at rest or movement; 1 = no nausea and vomiting at rest, slight at movement; 2 = intermittent nausea and vomiting at rest, moderate on movement; 3 = continuous nausea and vomiting at rest and severe on movement.
2. Daily post-operative sedation recorded and scored as following: 0 = none, patient is alert; 1 = mild, awake but drowsy; 2 = moderate, asleep but rousable; 3 = severe, unrousable. 3. Adverse events caused by the TAP block procedure. These will include evidence of inflammation or infection at the administration sites or adverse effects of the local anaesthetic agent or saline. 4. Duration of post-operative stay. Patients will make their own decision about fitness for discharge from hospital. This decision will not be affected by the views of the medical and nursing team, except in the event of complications. 5. Time to the introduction of free oral fluids and the first solid food. Patients will make their own decision about the intake of fluids and solids. This decision will not be affected by the views of the medical and nursing team, except in the event of complications. 6. Timed up and go. Patients are timed as they rise from a chair, walk 3 metres, turn, walk back and sit. This will be measured before surgery and on post-operative days 1 and 3. 7. Grip strength. A hydraulic Hand Dynamometer is used to measuring grip strength (kg). The scores of 3 successive trials using the right and left hand will be measure before surgery and on each post-operative day until day 7 or at discharge, whichever is sooner. 8. Inflammation, cytokines (IL-1, IL-6 and TNF alpha). A blood sample will be taken pre-operatively and post-operatively at 6, 24 and 48 hours in addition to routine daily blood samples. The blood will be centrifuged and the plasma stored at -80°C until analysed. |
| Sources of funding |
1. University Hospitals of Leicester NHS Trust (UK)
2. University of Leicester (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Michael Nicholson |
| Address |
Transplant Group
University of Leicester Leicester General Hospital |
| City/town | Leicester |
| Zip/Postcode | LE5 4PW |
| Country | United Kingdom |
| Sponsor | University of Leicester (UK) |
| Address |
c/o Mr Graham Hewitt
School of Medicine Medical School Office Maurice Shock Building PO Box 138 University Road |
| City/town | Leicester |
| Zip/Postcode | LE1 9HN |
| Country | United Kingdom |
| Sponsor website: | http://www2.le.ac.uk/ |
| Date applied | 14/06/2010 |
| Last edited | 11/08/2010 |
| Date ISRCTN assigned | 11/08/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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