Paravertebral Versus Caudal Block in Pediatric PCNL

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05012215
Collaborator
(none)
60
1
2
7
8.6

Study Details

Study Description

Brief Summary

To compare the efficacy of Ultrasound guided thoracic paravertebral block versus ultrasound guided caudal epidural block in pediatric patients undergoing percutaneous nephrolithotomy

Condition or Disease Intervention/Treatment Phase
  • Procedure: Paravertebral
  • Procedure: Caudal block
N/A

Detailed Description

Percutaneous Nephrolithotomy (PCNL) is a commonly performed surgical procedure for complex upper renal tract calculi. Although the skin incision for PCNL appears small, the intensity of intraoperative and postoperative pain is significant owing to soft tissue injury.

Paravertebral block is the technique of injecting local anesthetics in a space immediately lateral to where the spinal nerves emerge from the intervertebral foramina. This technique is used increasingly for intra-operative and post-operative.

Caudal epidural block involves placing a needle through the sacral hiatus to deliver medications into the epidural space. This approach is used widely used for surgical anesthesia and analgesia in pediatric patients.

this work aims to compare the efficacy of Ultrasound guided thoracic paravertebral block versus ultrasound guided caudal epidural block in pediatric patients undergoing percutaneous nephrolithotomy

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Ultrasound Guided Thoracic Paravertebral Block Versus Ultrasound Guided Caudal Epidural Block in Pediatric Patients Undergoing Percutaneous Nephrolithotomy
Actual Study Start Date :
Aug 19, 2021
Anticipated Primary Completion Date :
Mar 20, 2022
Anticipated Study Completion Date :
Mar 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Paravertebral

Ultrasound-guided thoracic paravertebral block

Procedure: Paravertebral
Ultrasound-guided paravertebral block

Active Comparator: Caudal

Caudal block

Procedure: Caudal block
Caudal block

Outcome Measures

Primary Outcome Measures

  1. Blood pressure during surgery in mmHg [through the surgery, an average of 2 hours]

  2. Heart rate (beats/minute) [through the surgery, an average of 2 hours]

  3. The concentration of sevoflurane in % [through the surgery, an average of 2 hours]

  4. Postoperative pain using FLACC score [up to 12 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients undergoing percutaneous nephrolithotomy
Exclusion Criteria:
  • Coagulation disorders

  • Infection at the site of injection

  • Allergy to the local anesthetics used

  • Spinal cord abnormalities or neurological deficits

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut University Assiut Egypt 71515

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hany Mostafa Esmaeil Osman, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05012215
Other Study ID Numbers:
  • Paravertebral Caudal PCNL
First Posted:
Aug 19, 2021
Last Update Posted:
Aug 20, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Hany Mostafa Esmaeil Osman, Principal Investigator, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 20, 2021