COMPARISON OF TWO REGIONAL BLOCKS FOR PAIN RELIEF IN CHILDREN UNDERGOING OPEN PYELOPLASTY.

Phase 2

Active, not recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/09/045987
• Lead Sponsor: SIR GANGA RAM HOSPITAL

Brief Summary

With the increasing use of ultrasound guided interventions, the erector spinae plane block (ESPB) is slowly gaining popularity for perioperative analgesia in paediatric surgeries. ESPB is a novel interfascial plane block in which a local anaesthetic agent is injected under USG guidance between the Erector spinae muscle and the underlying vertebral transverse processes. In comparison to the popular central neuraxial caudal epidural block (CEB), the ESPB is superficial, and there are no major neurovascular structures in close vicinity of the fascial plane. Applying the ESPB post induction in a surgery like pyeloplasty under GA will thus reduce the chances of neurovascular injury and also decrease the requirements of systemic and opioid analgesics. This will reduce the incidence of respiratory depression, confusion, nausea, vomiting, drowsiness, and prolonged hospital stay etc. seen with opioid use. The proposed randomized controlled study aims to compare the perioperative analgesic efficacy of ESPB vs. CEB in children with PUJ obstruction undergoing pyeloplasty. The study will be carried out among 60 subjects divided into two groups. FLACC score will be measured postoperatively at subsequent time intervals namely at 0 min, 30 min, 1h, 2 h, 3hr, 6 h, 12 h, 18 h and 24 h. Following induction of anaesthesia, Group ESPB will receive an ultrasound guided erector spinae plane block and Group CEB will receive a caudal epidural block. We hypothesize that administration of an ultrasound guided single shot ESPB post induction in an open pyeloplasty operation will be more efficacious for perioperative analgesia and reduce the need for systemic opioids, as compared to a single shot CEB.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-10
• Last Update Posted: 2024-02-19

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Open pyeloplasty 2.
• Children between 2 months to 7 years of age.
• ASA grade I and II.

Exclusion Criteria

• 1.Hypersensitivity to ropivacaine and clonidine 2.
• Spine or chest wall deformity 3.
• Impaired cardiac, hepatic or neurological function 4.
• Patients with coagulative disorders 5.
• Parents unwilling to participate 6.
• Developmental delay 7.
• Undergoing additional surgical procedure at an anatomical location not covered by unilateral ESPB.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perioperative fentanyl usage (Intraoperative and postoperative fentanyl usage will be	Perioperative period
measured.)	Perioperative period

Secondary Outcome Measures

Name	Time	Method
1. Time to first rescue analgesia in Post Anaesthesia Care Unit	2. Haemodynamic stability by comparing the haemodynamic parameters (heart rate and

Trial Locations

Locations (1)

SIR GANGA RAM HOSPITAL; 🇮🇳 Central, DELHI, India

SIR GANGA RAM HOSPITAL

🇮🇳Central, DELHI, India

DR DEEPANJALI PANT

Principal investigator

9818271871

deepanjalipant@gmail.com