This study will involve the administration of levobupivacaine 0.25% and 0.125%, a local anaesthetic agent licensed for this purpose, into the epidural and paravertebral space, to provide postoperative analgesia for adults having open renal surgery. We aim to compare the analgesic efficacy of paravertebral and epidural blockage, for post operative pain in the first 24 post operative hours. MedDRA version: 9.1 Level: LLT Classification code 10054711 Term: Postoperative pain
Conditions
Interventions
Trade Name: Chirocaine
Product Name: Levobupivacaine
Pharmaceutical Form: Solution for infusion
Trade Name: Chirocaine
Product Name: Levobupivacaine
Pharmaceutical Form: Solution for infusion
Trade
Sponsors
Department of Anaesethesia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults 18-80 years Presenting for elective open renal surgery ASA 1 to 3 Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient refusal Contraindication to neuraxial blockade Local infection at site of insertion Allergy to levobupivacaine, fentanyl, paracetamol or morphine. Sepsis Severe kyphoscoliosis Previous thoracic vertebral surgery Systemic anticoagulation or coagulopathy Uncontrolled hypertension Uncontrolled Diabetes Mellitus Severe liver or cardiac dysfunction Inability to comprehend pain scoring system or perform spirometry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Pain assessment in the first 24 hours, (VAS and categorical pain scores) Morphine requirement in first 24 hours;Main Objective: We aim to compare the analgesic efficacy of paravertebral and epidural blockage, for post operative pain in the first 24 post operative hours, following open renal surgery. 1. Severity of Postoperative Pain, [VAS and Categorical pain Scales] 2. Total opiate usage in the first 48 hours after surgery;Secondary Objective: Poorly controlled analgesia is associated with prolongation of hospital stay, and increased morbidity. The use of epidural and paravertebral nerve blocks is a well-established approach to postoperative analgesia. We plan to show that both epidural and paravertebral analgesia will provide very satisfactory analgesia post operatively. The use of epidural is associated with more blood pressure instability, higher fluid requirement to maintain blood pressure and urine production, and also leg weakness delaying mobilization. We plan to show a statistically significant difference in these side effects. 1Cardiovascular hemodynamics 2Respiratory function 3Fluid requirement in first 24 hours 4Hourly urine output in first 24 hours 5Sedation 6Postoperative nausea, vomiting and itch 7Patient Satisfaction | — |
Countries
Ireland
Outcome results
None listed