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Perfusion IndexNCT06203743

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

A study testing caudal block group and ilioinguinal-iliohypogastric nerve block group in people with Perfusion Index and Plethysmography, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 8 years
What is being tested?
caudal block group and ilioinguinal-iliohypogastric nerve block group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteTurkey (Türkiye)
Study dates
18 Jan 2024to 1 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 8 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 2-8 years old
  • Elective Inguinal hernia operation
  • ASA I-II patients

Who cannot join

  • <2 years to be >8 years old
  • ASA III-IV patients
  • Peripheral vascular disease
  • Diabetes Mellitus patient
  • Neuromuscular disease
  • Bleeding disorder
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bursa Yuksek Ihtisas Training and Research Hospital

    Bursa, Bursa

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Caudal Block and Ilioinguinal-ilioohypogastric Nerve Block Efficacy with Perfusion Index (PI) in Pediatric Inguinal Hernia Operations Under General Anesthesia

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.

Being tested
caudal block group, ilioinguinal-iliohypogastric nerve block group
Keywords
Perfusion Index, plethysmography variability index, caudal block, ilioinguinal iliohypogastric nerve block, nerve block, Inguinal hernia
Medical subject headings
Hernia, Inguinal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • caudal block groupProcedure or surgery

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

  • ilioinguinal-iliohypogastric nerve block groupProcedure or surgery

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

Study groups in NCT06203743
Study groupRoleWhat they receive
control groupNo interventionPatients 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.
caudal block groupActive comparatorPatients 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.
Receives: Procedure: caudal block group
ilioinguinal-iliohypogastric nerve block groupActive comparatorPatients 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.
Receives: Procedure: ilioinguinal-iliohypogastric nerve block group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: during the operation

Secondary outcomes (3)
  1. FLACC pain scale

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

    Measured: up to six hour

  2. Analgesic use

    Amount and number of analgesics used postoperatively

    Measured: 1 day

  3. Duration of discharge

    Discharge time after surgery

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2024
  2. Study start18 Jan 2024
  3. Primary completion1 Jun 2024
  4. Study completion1 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The research is a prospective controlled, randomized, double-blind study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06203743
Sponsor's protocol ID
BYIEAH-AKD-01
Status last verified
Feb 2025
First submitted
11 Dec 2023
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing caudal block group and ilioinguinal-iliohypogastric nerve block group in people with Perfusion Index and Plethysmography, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PI and PVI (time frame: during the operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.

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