Comparison of three drugs used in anaesthesia for caudal block in children

Phase 4

Completed

• Conditions: Healthy ASA-1 and ASA-2 Patients who consented to go under study

• Registration Number: CTRI/2018/03/012402
• Lead Sponsor: Dr Jagdeep Sharma

Brief Summary

There is limited data comparing all the three drugs. So, this study was performed to evaluate the caudal effectiveness of levobupivacaine, bupivacaine and ropivacaine in paediatric patients indergoing infra umbilical surgeries and associated complications with these drugs. This study also tried to find out difference in cardiac complications associated with these drugs.The diiference in mean caudal effectiveness score in all the three groups was statistically insignificant(p>0.05).21 patients in group I (Levobupivacaine), 19 patients in group II( Ropivacaine) and 22 patients in group III(Bupivacaine) had a caudal effectiveness score of 3. Mean postoperative pain scores as assessed with modified hanallah pain score were lower in bupivacaine group as compared to levobupivacaine and ropivacaine group during 1st hour post operatively. The duration of post operative analgesia in group I(levobupivacaine) was 126.15 mins, group II ropivacaine was 114.68 mins, and bupivacaine was 145.31 mins. The difference in duration of post operative analgesia was statistically highly significant.(p<0.001).Levobupivacaine and ropivacaine provided similar duration of post operative analgesia. Bupivacaine provided longer duration of analgesia than levobupivacaine and ropivacaine.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-20
• Study Completion: 2014-08-28
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

90 patients of ASA grade I & II, undergoing infraumbilical surgery as circumscision, herniotomies, orchidopexies etc.

Exclusion Criteria

Refusal by parents or guardian, pre existing neurological disease, hypersensitivity to local anaesthetics under study, bleeding diathesis or coagulation disorder, local sepsis at the site of puncture and technical problems such as persistent paresthesias or bloody/CSF tap.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Caudal Effectiveness Score among the three groups was assessed.	The Caudal Effectiveness score was assessed after administration of anaesthesia before beginning of the surgery.

Secondary Outcome Measures

Name	Time	Method
Mean pain scores, duration of post operative analgesia and associated compplications with the use of the drugs.	. The duration of postoperative analgesia in group I (levobupivacaine) was 126.15±15.15mins (2.10±0.25hrs), group II (ropivacaine) was 114.68±11.32mins (1.91±0.18hrs), group III (bupivacaine) was 145.31±15.15mins (2.42±0.43hrs.

Trial Locations

Locations (1)

Shri Guru Ram Das Institute of Medical Sciences And Research; 🇮🇳 Amritsar, PUNJAB, India

Shri Guru Ram Das Institute of Medical Sciences And Research

🇮🇳Amritsar, PUNJAB, India

Jagdeep sharma

Principal investigator

9988765759

snehlatas222@gmail.com