NCT05958589

Brief Summary

This is a prospective, randomized, controlled clinical study designed to determine the effectiveness of caudal block combined with general anesthesia in providing intra- and postoperative analgesia, and its effect on hemodynamic stability and drug consumption.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_3 postoperative-pain

Timeline
Completed

Started Jan 2022

Longer than P75 for phase_3 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2024

Completed
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

2.5 years

First QC Date

July 7, 2023

Last Update Submit

December 3, 2024

Conditions

Postoperative Pain

Keywords

general anesthesiacaudal blockpainhemodynamic parameters

Outcome Measures

Primary Outcomes (2)

  • Postoperative pain

    Postoperative pain level measured using the visual analog scale (VAS)

    5 hours

  • Postoperative pain

    Postoperative pain level measured using the Wong-Baker Faces pain rating scale

    5 hours

Secondary Outcomes (2)

  • Blood pressure

    5 hours

  • Heart rate

    5 hours

Study Arms (2)

General anesthesia + caudal block

EXPERIMENTAL

General anesthesia with intravenous anesthetic propofol (2-3 mg/kg), opioid analgesic fentanyl (1-1.5 mcg/kg), and muscle relaxant rocuronium - bromide (0.6-1 mg/kg), in combination with a single shot caudal block with levobupivacaine 0.25% (2.5 mg/kg; maximal dose 75 mg).

Drug: Caudal block with levobupivacaineDrug: General anesthesiaProcedure: Inguinal hernioplasty

General anesthesia

ACTIVE COMPARATOR

General anesthesia with intravenous anesthetic propofol (2-3 mg/kg), opioid analgesic fentanyl (1-1.5 mcg/kg), and muscle relaxant rocuronium - bromide (0.6-1 mg/kg)

Drug: General anesthesiaProcedure: Inguinal hernioplasty

Interventions

Caudal block with levobupivacaineDRUG

After the introduction of general anesthesia, a single shot caudal block will be performed with levobupivacaine 0.25% (2.5 mg/kg; maximal dose 75 mg).

General anesthesia + caudal block
General anesthesiaDRUG

On the day of operation all patients will recieve midazolam 0.5 mg/kg (maximum dose 15 mg) orally. Induction of anesthesia will be the same for all patients and consist of intravenous anesthetic propofol (2-3 mg/kg), opioid analgesic fentanyl (1-1.5 mcg/kg), and muscle relaxant rocuronium - bromide (0.6-1 mg/kg). The airway will be obtained by placing a laryngeal mask (I-gel®).

General anesthesiaGeneral anesthesia + caudal block
Inguinal hernioplastyPROCEDURE

Elective inguinal hernioplasty

General anesthesiaGeneral anesthesia + caudal block

Eligibility Criteria

Age3 Years - 5 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • boys between 3 to 5 years old
  • scheduled for elective inguinal hernioplasty
  • without comorbidities and chronic therapy, ASA class I
  • body mass and growth normal for the given age
  • no allergies
  • no congenital anomalies and birth complications

You may not qualify if:

  • emergency surgeries
  • surgeries longer than 60 minutes
  • acute infections with leucocytosis/leucopenia
  • acute or chronic diseases
  • deformities and disorders of spine and nervous system
  • allergies
  • pilonidal cyst and/or inflammation in sacral region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for health care of children and youth of Vojvodina

Novi Sad, Vojvodina, 21000, Serbia

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

LevobupivacaineAnesthesia, General

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

July 7, 2023

First Posted

July 24, 2023

Study Start

January 8, 2022

Primary Completion

July 20, 2024

Study Completion

July 20, 2024

Last Updated

December 4, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)