Comparison of two drugs( ropivacaine and levobupivacaine )in children for relief of pain, with regional block (caudal)in surgery below umbilical under general anaesthesia

Phase 2/3

Recruiting

• Conditions: Disorder of urinary system, unspecified,

• Registration Number: CTRI/2019/08/020801
• Lead Sponsor: Department of anaesthesia

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-09
• Last Update Posted: 2021-08-11

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Quality of analgesia by MOPS Score after administration of 0.25% caudal levobupivacaine	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	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.	MOPS scoring will be done every 30 minutes for 2 hours after reversal of anesthesia, then hourly till the time first rescue analgesia given

Trial Locations

Locations (1)

PGIMER Dr RMLHospital; 🇮🇳 Delhi, DELHI, India

PGIMER Dr RMLHospital

🇮🇳Delhi, DELHI, India

Shashi Kumar Gupta

Principal investigator

7531047685

shashigupta998@gmail.com