None listed
Conditions
Brief summary
We have in our group together with our colleagues at the paediatric anaesthesia department and neonatal department since over a decade had a great interest in finding local anaesthesia methods that even our most immature patients can take advantage of. The Primary aim of this study is to demonstrate that Wound catheter infusion (WCI) with local anaesthetics is at least as effective as Intravenous pain therapy( IVPT) regarding postoperative pain treatment after major thoracic or abdominal surgery in neonates. Secondary aims are to document effectiveness and safety of conventional intravenously pain treatment therapy (IVPT) and WCI after major thoracic or abdominal surgery in neonate as well as comparing wound healing in the two groups. In this prospective randomized study, a total of 30 full term infants, less than 3 months of age and scheduled for major abdominal or thoracic surgery will be included. After enrolment patients will be randomly assigned to receive either intravenous pain therapy or wound catheter infusion with levobupivacaine for postoperative pain treatment. Data collection will start postoperatively in the PICU. Pharmacokinetic and pharmacodynamic data will be collected for 72 hours. The surgical wound healing process will be monitored for 10 days and later at follow up. Pain intensity will be analysed and compared in the two groups.
Interventions
WCI (Wound catheter infusion group)
Wound catheter 19 G PainBuster®, Amaro, Italy; length 2.5 or 6.5 cm.
The wound catheter is put into place before skin closure by the paediatric surgeon at the end of surgery.
Bolus dose levo-bupivacaine (AbbVie AB, 1,25 mg/ml). Immediately after skin closure a bolus dose of levo-bupivacaine 0.5 mg/kg is administered through the wound catheter.
Postoperative continuous infusion levo-bupivacaine (AbbVie AB, 1,25 mg/ml). At arrival to the PICU a continuous infu
WCI (Wound catheter infusion group) Wound catheter 19 G PainBuster®, Amaro, Italy; length 2.5 or 6.5 cm. The wound catheter is put into place before skin closure by the paediatric surgeon at the end of surgery. Bolus dose levo-bupivacaine (AbbVie AB, 1,25 mg/ml). Immediately after skin closure a bolus dose of levo-bupivacaine 0.5 mg/kg is administered through the wound catheter. Postoperative continuous infusion levo-bupivacaine (AbbVie AB, 1,25 mg/ml). At arrival to the PICU a continuous infusion of levo-bupivacaine is started at a rate of 0.2 mg/kg/h, using an infusion pump (Perfusor® Space, B Braun, Melsungen AG, Germany). The study period (IVPT/WCI) will continue for 72 hours. The WCI catheter is thereafter removed by independent personnel. If pain treatment still is required clinical routine is followed. Coexistent pain therapy - Concomitant medication, both IVPT and WCI Paracetamol: According to clinical routine ALL study patients (IVPT and WCI group) will have a prescription of paracetamol (Fresenius Kabi, 10 mg/ml) delivered intravenously 4 times per day (7,5-15 mg/kg). Rescue dose: A “rescue” dose of intravenous administered morphine (Morfin meda, 1 mg/ml) will be prescribed (25-50 microg/kg) to be administered if pain scores indicate pain (Comfort-B), A special protocol is used for this. Further, a “rescue” dose of intravenous administered clonidine (Boehringer Ingelheim International GmbH, 15 microg/ml) will be prescribed (0,5-1 microg/kg) to be administered if pain scores indicate pain. Other drugs: In this study there are no limitations concerning other drugs, such as antibiotics, diuretics etc.
Sponsors
Karolinska University Hospital , Region Stockholm
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
No minimum to 3 Months
Healthy volunteers
No
Inclusion criteria
Less than 3 month of age Full term (>gestational week 36+6) Scheduled for major abdominal or thoracic surgery Approved and documented written and oral consent from both parents
Exclusion criteria
Absence of parental consent Allergy to local anesthetics Known or suspected liver-, kidney dysfunction or neurological disorder associated with peripheral nerve damage. Intraperitoneal infection/sepsis. Reoperation within 6 weeks. Infants with another severe coexisting sickness (>ASAIII) Coagulation disorder. Protocol violation.
Outcome results
None listed