Trial Information

Early Versus Late Paravertebral Block for Analgesia in Video Assisted Thoracoscopic Lung Resection.

All patients will receive a general anaesthetic for their VATS procedure with full AAGBI
monitoring and the WHO surgical safety checklist will be performed appropriately prior to
skin incision. Induction of anaesthesia will be standardised by using propofol and the
patient will be paralysed using the muscle relaxant atracurium. The amount given will be at
the anaesthetist's discretion and dependent on the patient. Fentanyl at 2.5 mcg/kg will be
used at induction of anaesthesia.

A double lumen endotracheal tube will be placed so lung isolation can be performed when
necessary for the surgery. Anaesthesia will be maintained using a volatile agent or a target
controlled infusion of propofol depending on the preference of the anaesthetist. The patient
will be positioned laterally with the operative side up. All patients will receive simple
intra-operative analgesia in the form of 1 gram of intravenous paracetamol and diclofenac
unless the patient is over 70 or has abnormal renal function. Extra opioid analgesia will be
given as intravenous morphine and this will be titrated by the anaesthetist. The amount
given will be documented as part of the trial data.

Patients will be warmed to maintain a temperature between 36 and 37 degree Celsius using a
warming blanket and warmed intravenous fluids. Anti-emetics in the form of ondansetron 4 mg
and dexamethasone 4 mg will also be given unless there are any contraindications.

Prior to surgical incision patients in both groups will receive 1mg/kg 0.25% bupivicaine
divided into 3 PV injections between the fifth and tenth thoracic vertebrae. Only trained
anaesthetists with experience of over 30 PV insertions will perform the injections. The
landmark technique for these injections is as follows: The spinous process of the thoracic
vertebra is palpated by the anaesthetist, a 20 gauge needle is inserted 2.5 cm lateral to
this and is advanced perpendicularly to the vertical and sagittal planes until the
transverse process is contacted. The needle is then walked off the superior border of the
transverse process, advanced a further 1 cm and one third of the weight determined local
anaesthetic is delivered after careful aspiration.

Both groups will have a PV catheter placed at the start of the procedure and a bolus given
straight away. As this is a double-blinded trial the anaesthetist will not know whether the
bolus is local anaesthetic or saline solution.

Pharmacy at the research site will provide the 2 premade syringes that will contain either
local anaesthetic or saline. The contents of the syringe will be unknown to the anaesthetist
as the label will be simply numbered as 1 and 2 to be given in order as the early (1) or
late (2) bolus. If it is clinically required to obtain information on what has been given a
record will be immediately available from pharmacy. The syringes will be made up as neat
0.25% bupivicaine or 0.9% Normal Saline solution. The equivalent volume of 1mg/kg 0.25%
bupivicaine will be injected as a bolus.

Both groups will also receive a 0.25mg/kg 0.25% bupivicaine intercostal block at closing and
an infusion of 0.1% bupivicaine will then be commenced at 20mls/hr to continue over the post
operative period. Intra-operatively the amount of local anaesthetic given will be under the
maximum dose of 2 mg/kg. The maximum dose will not be reached even when the infusion
commences due to the fact that time will have passed.

The primary outcome measures that will be used are to review pain scores using VAS on
coughing. This will start at arrival in recovery room, which will be described as time zero.
It will then be reviewed at time 1,2,4,6,12 and 24 hours. The pain scores are routinely
measured by the nurses after this type of surgery, the only difference for the study will be
that these scores are measured more often, a timer will be placed with the patient to
indicate when the scores should be taken.

Secondary outcome measures will include morphine consumption, which will be noted
peri-operatively then again at the time intervals described above. These will be recorded by
the recovery staff initially and then continued by the ward nurses with the support of the
research team.

Other secondary outcomes measured will include cortisol levels the following day, which will
allow review of the neuroendocrine response. The patient will have routine blood tests the
morning after the surgery; the cortisol level will be added to this test so the subject will
not have extra blood taken. Patient satisfaction scores will be recorded in the form of a
questionnaire and will be recorded on the first 2 post-operative days. The length of
hospital stay, readmission at 30 days, survival at 30 days and infection rates will also be
noted.