Ratifying dosage and duration of levo-bupivacaine infusion in infants.
Research type
Research Study
Full title
Clinical trial of the investigational medicinal product, local anaesthetic levo-bupivacaine in infants 3 - 6 months post natal age.
IRAS ID
167382
Contact name
Rita Vashisht
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Eudract number
2015-000393-34
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
In infants pain relief is commonly provided by injecting local anaesthetic at the base of the infant’s spine (caudal space). If a small tubing is inserted into this space then local anaesthetic infused continuously prolongs the duration of pain relief.
The local anaesthetic is also absorbed into the bloodstream and broken down in the infant liver before being excreted in the urine. Due to immaturity of the liver's metabolic pathways in infants less than 6 months, high levels in the blood are possible. This then acts on the brain and heart can causing toxic side effects such as fits or abnormal heart beats.
Present dosing schedules are based on evidence from the pharmacokinetic studies of the local anaesthetic bupivacaine. However, with this, side effects on the heart and brain are more difficult to treat. Hence we use levo-bupivacaine which is similar in structure and analgesic properties but is safer. At present we do not know what blood levels are reached using a bolus followed by an infusion of levo-bupivacaine or when the infusion should start after the bolus.
Bladder exstrophy is a rare abnormality of the bladder present at birth (1:200,000). The skin and muscle over the lower part of the tummy does not develop properly. The urinary bladder is open and exposed. Surgical repair takes 6-8 hours. Using this population group, we can study the levels of the local anaesthetic in blood using present protocols and without any added interventions. We would have to collect blood samples periodically for analysis.
Our study measures the levels of levo-bupivacaine in the blood when a bolus dose is followed by an infusion, in infants 3 – 6 months, over a period of 72 hours.
It will validate the safety of the present dosing schedules and would be useful in other infants undegoing major surgery.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
15/NW/0240
Date of REC Opinion
17 Apr 2015
REC opinion
Favourable Opinion