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CompletedNCT06203743Updated Feb 19, 2025

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

An interventional study of caudal block group and ilioinguinal-iliohypogastric nerve block group in Perfusion Index, Plethysmography and Anesthesia, Caudal, sponsored by Bursa Yüksek İhtisas Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 2 Years to 8 Years. Per ClinicalTrials.gov, last updated 2025-02-19.

Sponsored by Bursa Yüksek İhtisas Education and Research Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
2 Years to 8 Years
Sex
All
01

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.

Read the detailed description

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.

ASA III-IV patients, patients with peripheral vascular disease, patients with diabetes mellitus, patients with neuromuscular disease, patients with bleeding disorders, patients with infection at the site of the block, patients with infection at the site of perfusion index probe adhesion, patients with bilateral inguinal hernia operation, patients with inguinal hernia operation with circumcision, patients with emergency operation, patients with mental retardation, patients who do not speak Turkish, patients with local anesthetic allergy, patients who do not give consent to participate in the study will not be included.

After the patients scheduled for inguinal hernia surgery are admitted to the operating room, routine monitoring will be performed as performed in the clinic. 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 and covered with gauze to prevent exposure to ambient light. Patients will be given anaesthetic drugs as routinely administered (propofol 1-3mg/kg, fentanyl 1-2mcg/kg), followed by placement of an appropriately sized supraglottic airway device (LMA) and maintenance of anaesthesia with oxygen, air and sevoflurane. 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. Caudal block is performed in the left lateral decubitus position after sterile conditions are provided, the sacral cornuas are palpated and a 25 gauge caudal needle (egemen international brand 25g 30 mm) is advanced at an angle of 45 degrees. After the needle hits the sacrum, the angle is reduced by retreating a few millimetres and the epidural area is reached in the sacral canal. After controlling the absence of blood and cerebrospinal fluid by negative aspiration, Buvasin® will be administered at a dose of 0.25%, 0.5 ml/kg. Ilioinguinal-iliohypogastric nerve block will be performed by placing the linear probe transversely-obliquely in the direction of the line connecting the spina iliaca anterior superior and the umbilicus under ultrasound guidance after sterile conditions are provided while the patient is in the supine position. The block needle (braun brand stimplex ultra 360 block needle) is inserted with in-plane technique in the same plane with the ultrasound probe. External and Internal Oblique Muscle and Transversus Abdominus Muscle layers and nerves are determined, needle tip localisation is determined, aspirated at frequent intervals and 0.25% Buvasin® 0.5ml/kg is given to the neurofascial plan. 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.

02

Conditions studied

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

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Keywords

  • Perfusion Index
  • plethysmography variability index
  • caudal block
  • ilioinguinal iliohypogastric nerve block
  • nerve block
  • Inguinal hernia
03

In context

Hernia, Inguinal

543 studies on the registry are indexed under Hernia, Inguinal; 92 are open to participants now.

This study's enrollment of 102 is above the median of 90 across 395 interventional studies indexed under Hernia, Inguinal.

Browse Hernia, Inguinal studies →

Lead sponsor

Bursa Yüksek İhtisas Education and Research Hospital is the lead sponsor of 62 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 2-8 years old
  • Elective Inguinal hernia operation
  • patients

Exclusion criteria

Exclusion Criteria:

  • \<2 years to be >8 years old
  • patients
  • Peripheral vascular disease
  • Diabetes Mellitus patient
  • Neuromuscular disease
  • Bleeding disorder
  • Infection in the area to be blocked
  • Infection at the perfusion index probe adhesion site
  • Bilateral inguinal hernia operation
  • Inguinal hernia operation with circumcision
  • Cases taken to emergency operation
  • Mental retardation
  • Not knowing Turkish
  • Allergy to local anesthetics
  • Refusal to participate in the research
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
102 participants (actual)

Study arms

  • No intervention
    control group

    Patients in this group will not undergo any block after LMA. PI, PVI, pulse, saturation, noninvasive arterial pressure values will be recorded before induction, after induction, after LMA, at 0, 5, 10, 15, 20, 25 and 30 minutes after the surgical incision and at the end of anesthesia. PI, PVI will be monitored with Radical-97TM Pulse CO-OximeterTM (Masimo Corp, Irvine, CA, USA) probe.

  • Active comparator
    caudal block group

    Patients in this group will receive a caudal block in the lateral decubitus position after LMA with 0.25% Buvasin® 0.5ml/kg. PI, PVI, pulse, saturation, noninvasive arterial pressure values before induction, after induction, after LMA, before applied block, after applied block (after surgical incision) 0., 5., 10., 15., 20., 25. It will be recorded at the 30th and 30th minutes and at the end of anesthesia. PI, PVI will be monitored with Radical-97TM Pulse CO-OximeterTM (Masimo Corp, Irvine, CA, USA) probe.

    Procedure: caudal block group

  • Active comparator
    ilioinguinal-iliohypogastric nerve block group

    Patients in this group will undergo an ilioinguinal-iliohypogastric nerve block in the supine position under ultrasound guidance after LMA with 0.25% Buvasin® 0.5ml/kg. PI, PVI, pulse, saturation, noninvasive arterial pressure values before induction, after induction, after LMA, before applied block, after applied block (after surgical incision) 0., 5., 10., 15., 20., 25. It will be recorded at the 30th and 30th minutes and at the end of anesthesia. PI, PVI will be monitored with Radical-97TM Pulse CO-OximeterTM (Masimo Corp, Irvine, CA, USA) probe.

    Procedure: ilioinguinal-iliohypogastric nerve block group

Interventions

  • Procedurecaudal block group

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

  • Procedureilioinguinal-iliohypogastric nerve block group

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

06

What researchers measure

Primary outcomes

  1. PI and PVI

    PI and PVI will be measured using a Radical-97TM Pulse CO-OximeterTM (Masimo Corp, Irvine, CA, USA) probe. PI, PVI and hemodynamic data will be used to evaluate the efficacy of the blocks and the pain status of the patients.

    Time frame: during the operation

Secondary outcomes

  1. FLACC pain scale

    Face, Legs, Activity, Cry, Consolability (FLACC) pain scale to be administered in the first 6 hours after surgery

    Time frame: up to six hour

  2. Analgesic use

    Amount and number of analgesics used postoperatively

    Time frame: 1 day

  3. Duration of discharge

    Discharge time after surgery

    Time frame: 1 day

07

Study locations

1 site
  • Bursa Yuksek Ihtisas Training and Research Hospital
    Bursa, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06203743
Lead sponsor
Bursa Yüksek İhtisas Education and Research Hospital
Responsible party
Aycan KURTARANGİL DOĞAN (Doctor of anesthesiology and reanimation, Bursa Yüksek İhtisas Education and Research Hospital) — Principal investigator
First posted
Jan 12, 2024
Start date
Jan 18, 2024
Primary completion
Jun 1, 2024
Completion
Jun 1, 2024
Last update
Feb 19, 2025

Study contacts

Aycan Kurtarangil Doğan
principal investigator · akurtarangil@gmail.com

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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