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A clinical trial comparing most effective pain relief after surgery among the two blocks given for children undergoing open hernia surgery.

Phase 2
Not yet recruiting
Conditions
Acquired deformity of musculoskeletal system, unspecified, (2) ICD-10 Condition: O||Medical and Surgical,
Registration Number
CTRI/2025/05/086595
Lead Sponsor
Sapthagiri institute of Medical sciences
Brief Summary

This study is a randomized double controlled trial, comparing the analgesic efficacy of ultrasound guided caudal epidural block with retrolaminar block using bupivcaine.The primary aim of this study, is to compare the postoperative analgesic efficacy of both the blocks,by using duration of post-operative analgesia and time to firstrescue analgesic requirement. Secondary outcome includes, number of patientsrequiring rescue analgesia, total analgesic consumption in the first 24h postoperatively, adverse events and parental and surgeon satisfaction score.Fifty children undergoing elective unilateral open inguinal hernia repair willbe enrolled in the study

Post-operative pain will be assessed with FLACCscore and rescue analgesia will be given if FLACC score is more than three.Time to firstrescue analgesic requirement, number of rescue analgesics in 24 hour period, parentaland surgeon satisfaction,post-operative adverse events such as nausea, vomiting, hypotension,urinary retention will be recorded.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
50
Inclusion Criteria
  • 1.All the patients scheduled for for elective unilateral open inguinal hernia repair under general anaesthesia.
  • 2.ASA physical status I and II 3.Age 2-6 years.
Exclusion Criteria
  • 1.Patients with known allergies to local anaesthetics.
  • 2.Unwillingness to participate in the study 3.Infection at injection site 4.Coagulation disorders 5.Liver and kidney disease.
  • •Children with active respiratory tract infection.
  • •Patients having a history of mental retardation/developmental delay.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To assess the post-operative analgesic efficacy between Caudal epidural block and Retrolaminar block in children undergoing elective unilateral open inguinal hernia repairPost-operative pain will be assessed with FLACC scale at 1,2,4,6,12 and 24 hours post surgery.Rescue analgesia will be given if FLACC score is more than three. For the first 2 hour Fentanyl 1mcg per kg ( every 15 minutes duration) and between 2 to 24 hour, oral Ibuprofen 10 mg per kg (maximum dose 10mg per kg every 8 hour) will be used.
Secondary Outcome Measures
NameTimeMethod
.Adverse events: nausea, vomiting, hypotension, urinary retention

Trial Locations

Locations (1)

Sapthagiri superspeciality hospital

🇮🇳

Bangalore, KARNATAKA, India

Sapthagiri superspeciality hospital
🇮🇳Bangalore, KARNATAKA, India
Dr Vinod Hosalli
Principal investigator
8310268837
simsanaesthesiology@gmail.com

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