COMPARISON OF EFFICACY BETWEEN 0.25% BUPIVACAINE AND 0.25% LEVOBUPIVACAINE FOR CAUDAL ANESTHESIA IN PEDIATRIC INFRAUMBILICAL SURGERIES
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Duration of analgesia
Study Overview
Brief Summary
In Anaesthesia, provision of pain relief is an essential part. One of the most popular regional blocks in children with higher success rate is caudal block for surgeries below the level of umbilicus. It is a useful adjunct technique during general anesthesia and for providing post of analgesia for infra umbilical operations. This technique is easier to perform and reduces the requirement of inhaled and intravenous anesthetic agent. It also attenuates the stress response to surgery, facilitates rapid and smooth recovery and provides reliable analgesia in the immediate post operative period. The quality and level of caudal block is dependent on the dose, volume and concentration of the drug injected. Bupivacaine is long-acting amide local anesthetic that has provided reliable anesthesia and analgesia with differential motor sensory blockade for more than 40years. Cardio toxicity and incidents of prolonged motor blockade urged the need for the development of a drug with wider margin of safety and similar clinical efficacy. So, S-enantiomers of bupivacaine were isolated and synthesized. One of the pure S-enantiomer of bupivacaine is levobupivacaine. It is claimed to have a wider margin of safety like less cardio toxicity and less post operative motor blockade.
Study Design
- Study Type
- Interventional
- Allocation
- Stratified block randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 2.00 Year(s) to 8.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients posted for elective infraumbilical surgeries.
- •Age between 2 years to 8 years of either sex.
- •Weight between 9 to 35kg.
- •Anticipated duration of surgery <60 minutes.
- •ASA grade І or â…¡.
Exclusion Criteria
- •Emergency surgeries.
- •Known hypersensitivity to amide local anaesthetics.
- •History of active neurological, cardiac, respiratory and renal diseases.
- •Blood dyscrasia, clotting disorders and platelet count <100000 mm
- •Patients with cutaneous infections or anatomical malformation of the spine.
- •Patients not willing to participate in the study.
Outcomes
Primary Outcomes
Duration of analgesia
Time Frame: pain score by FLACC score for every 15minutes in the first hour and every 30minutes for next hour
Secondary Outcomes
- To compare the duration of motor blockade between 0.25%bupivacaine and 0.25%levobupivacaine(duration of motor blockade by MODIFIED BROMAGE SCALE for every 15minutes in the first hour and every 30minutes for next hour)
- To compare the incidence of adverse effects between 0.25%bupivacaine and 0.25% levobupivacaine(Number of adverse effects in the perioperative period)
- To compare the hemodynamic parameters between 0.25%bupivacaine and 0.25% levobupivacaine(Pulse rate,Blood pressure and oxygen saturation from baseline to every 3minutes for 15minutes and every 5minutes for 30minutes and every 30 minutes fot 120 minutes)