Comparison of post-operative analgesia with caudal ropivacaine and levobupivacaine in paediatric patients undergoing infraumbilical surgery under general anaesthesia
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Recruiting
- Sponsor
- Department of anaesthesia
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 1. Quality of analgesia by MOPS Score after administration of 0.25% caudal levobupivacaine
Study Overview
Brief Summary
caudal epidural anaesthesia is a widely used technique in pediatric infraumbilical surgery . use of postoperative analgesia via the caudal epidural route with bupivacaine in pediatric patient is established in infraumbilical surgery . levobupivacaine and ropivacaine provide wider margine of safety , same analgesic effect and less post operative motor block than racemic mixture of bupivacaine in epidural block and both are well tolerated . so we proposed to evaluate the quality and duration of post operative analgesia and any side effects while using caudal block with ropivacaine and levobupivacaine
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 2.00 Year(s) to 6.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •pediatric patients of either sex with ASA physical status I&II, 2 to 6 yrs of age undergoing infraumbilical surgery.
Exclusion Criteria
- •local infection at injection site, Neurological disorders, allergy to local anaesthetic drug, sacral or vertebral abnormality, coagulopathy or anti-coagulation.
Outcomes
Primary Outcomes
1. Quality of analgesia by MOPS Score after administration of 0.25% caudal levobupivacaine
Time Frame: MOPS scoring will be done every 30 minutes for 2 hours after reversal of anesthesia, then hourly till the time first rescue analgesia given
2. Quality of analgesia by MOPS Score after administration of 0.25% caudal ropivacaine
Time Frame: MOPS scoring will be done every 30 minutes for 2 hours after reversal of anesthesia, then hourly till the time first rescue analgesia given
3. Duration of post operative analgesia by time to first rescue analgesia.
Time Frame: MOPS scoring will be done every 30 minutes for 2 hours after reversal of anesthesia, then hourly till the time first rescue analgesia given
Secondary Outcomes
No secondary outcomes reported