Transversus Abdominis Plane Block after laparoscopic live donor nephrectomy

ISRCTN	ISRCTN14709684
DOI	https://doi.org/10.1186/ISRCTN14709684
Protocol serial number	UHL 10883
Sponsor	University of Leicester (UK)
Funders	University Hospitals of Leicester NHS Trust (UK), University of Leicester (UK)

Submission date: 14/06/2010
Registration date: 11/08/2010
Last edited: 12/12/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims.
Keyhole (laparoscopic) live donor kidney removal (nephrectomy) is now a well-established operation in the UK and Leicester was the first unit in the UK to perform this operation and has now carried out more than 400 of these procedures. The laparoscopic technique reduces post-operative pain and the need for pain relieving medication (analgesics) compared to the traditional open operation to remove kidneys, which was performed through quite a large incision. Nonetheless, some patients still require a reasonable amount of pain relieving medication, including intravenous injections of morphine after laparoscopic nephrectomy. We wish to study methods of decreasing the amount of post-operative pain even further.
We would like to investigate the use of a local anaesthetic technique called the transversus abdominis plane (TAP) block. This is a method of anaesthetising or numbing the nerve endings in the abdominal wall at the site of the operation incisions. It involves injecting a local anaesthetic agent into this region after the patient has gone to sleep under general anaesthetic and before the surgery begins. Previous studies have shown that this technique can reduce pain after operations such as caesarean section but there are no studies, so far, in patients undergoing kidney donation.

Who can participate?
Every patient over 18 years that has completed the full work-up for laparoscopic donor nephrectomy and is eligible will be approached for the trial. A total of 50 patients, 25 in each group will be required for the study.

What does the study involve?
In this study, patients undergoing a laparoscopic donor nephrectomy at Leicester General Hospital will be randomly allocated to have either the TAP block, with local anaesthetic (Bupivacaine), or a similar procedure with an inert salt solution (saline) that does not contain any anaesthetic (the control group). The study will be a so-called blinded one in which the patient, the surgeon and the anaesthetist are unaware whether local anaesthetic has been used or not in a particular patient.
Outcomes of the study will be judged primarily on the amount of pain relief that is required and the level of pain patients experience after surgery. Recover will also be assessed and any nausea, vomiting and drowsiness recorded. The duration of hospital stay and time to the introduction of free oral fluids and first solid food will also be recorded. Blood samples will also be taken to assess the effects of surgery.

What are the possible benefits and risks of participating?
This study will help to determine if the TAP block procedure is beneficial to patients undergoing laparoscopic live donor nephrectomy.
Both Bupivacaine anaesthetic and normal saline are routinely used in clinical practice and should cause no adverse effects. The TAP block procedure will be performed by a Consultant Anaesthetist who is experienced in the technique and giving anaesthetics for kidney donation. As the TAP block involves injections into the skin, it is possible that this will cause a small amount of bruising in the region but this is likely to be very minor. Local anaesthetics do have some adverse effects if they are injected directly into blood vessels. In the unlikely event of this happening, it is possible that there could be effects on the heart and on the nervous system. Precautions are taken to prevent injection of anaesthetics into blood vessels and the injections will also be performed using ultrasound guidance which, again, makes the procedure safer. There will be no long term risks from taking part in this study.

Where is the study run from?
Leicester General Hospital

When is the study starting and how long is it expected to run for?
The study will start in June 2010 and end in June 2012

Who is funding the study?
The University of Leicester, Transplant Department

Who is the main contact?
Professor Michael Nicholson
mln2@le.ac.uk

Contact information

Prof Michael Nicholson
Scientific

Transplant Group
University of Leicester
Leicester General Hospital
Leicester
LE5 4PW
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised single centre double-blinded placebo controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised controlled trial of Transversus Abdominis Plane Block after laparoscopic live donor nephrectomy
Study acronym	TAP Block Trial
Study objectives	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.
Ethics approval(s)	Leicestershire, Northamptonshire and Rutland Ethics Committee 1 approved on the 8th June 2010 (ref: 10/H0406/12)
Health condition(s) or problem(s) studied	Post-operative pain
Intervention	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.
Intervention type	Other
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.
Key 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.
Completion date	23/06/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	50
Key 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
Key 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
Date of first enrolment	23/06/2010
Date of final enrolment	23/06/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Transplant Group

Leicester
LE5 4PW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/09/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes