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Evaluation of Caudal Block and Ilioinguinal-ilioohypogastric Nerve Block Efficacy with Perfusion Index (PI)

NCT06203743 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-02-19

No results posted yet for this study

Summary

The study is a prospective, randomised, controlled double-blind clinical trial. The primary aim was to evaluate the efficacy of caudal block and ilioinguinal-iliohypogastric nerve block with PI and PVI in pediatric inguinal hernia operations under general anesthesia. The secondary aim is to evaluate postoperative analgesic agent consumption and to evaluate the correlation of PI and PVI values with hemodynamic parameters. Pediatric patients between the ages of 2-8 years who are planned to undergo elective inguinal hernia operation will be included in the study. After the patients scheduled for inguinal hernia surgery are admitted to the operating room, routine monitoring will be performed as performed. In addition to routine monitoring, a Radical-97TM Pulse CO-OximeterTM (Masimo Corp, Irvine, CA, USA) probe will be attached to the toe to monitor PI and PVI. Patients will be given anaesthetic drugs as routinely administered. After LMA by randomisation by closed envelope method, caudal or ilioinguinal-iliohypogastric nerve block will be performed by an experienced anaesthetist as the investigators routinely perform in patients other than the control group.. PI, PVI, pulse, saturation, noninvasive arterial pressure values will be recorded before induction, after induction, after LMA, before applied block, after applied block (after surgical incision) at 0, 5, 10, 15, 20, 25 and 30 minutes and at the end of anaesthesia. All patients will be given paracetamol 10mg/kg iv, which is a routine intravenous (iv) analgesic, at the end of surgery. In case of perioperative complications, the complications will be recorded.

Flacc pain scale (Face, Legs, Activity, Cry, Consolability) will be applied at 0, 2, 6 hours postoperatively. Postoperative analgesic use and discharge time will be recorded. Flacc pain scale will be performed by an anaesthetist blinded to the study.

Conditions

  • Perfusion Index
  • Plethysmography
  • Anesthesia, Caudal
  • Nerve Block
  • Anesthesia, Regional
  • Child
  • Inguinal Hernia Unilateral

Interventions

PROCEDURE

caudal block group

PI, PVI measurements and hemodynamic data will be compared between groups

PROCEDURE

ilioinguinal-iliohypogastric nerve block group

PI, PVI measurements and hemodynamic data will be compared between groups

Sponsors & Collaborators

  • Bursa Yuksek Ihtisas Training and Research Hospital

    lead OTHER_GOV

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-18
Primary Completion
2024-06-01
Completion
2024-06-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06203743 on ClinicalTrials.gov