search
Back to results

Out Of-plane Technique Against In-plane for Caudal Block

Primary Purpose

Ultrasound Imaging, Caudal Block, Hypospadias

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Out of-Plane Technique and In-Plane on
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Ultrasound Imaging

Eligibility Criteria

6 Months - 10 Years (Child)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Pediatric patients undergoing hypospadias surgery
  • ASA PS I-II group

Exclusion Criteria:

  • Previous neurological or spinal disorder,
  • Coagulation anomaly
  • Allergy to local anesthetics
  • Local infection in the block area
  • Children with a history of preterm birth

Sites / Locations

  • Selcuk University, School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ultrasound Guided Out of-Plane Technique

Ultrasound Guided In-Plane Technique

Arm Description

Ultrasound Guided Out of plane technique (probe applied by holding horizontal)

Ultrasound Guided Out of plane technique (probe applied by holding vbertical)

Outcomes

Primary Outcome Measures

the success rates of in-plane and out of-plane techniques
To measure success rates of in-plane and out-of-plane techniques for caudal block, the number of successful processing and the time of processing (minute) will be used

Secondary Outcome Measures

The postoperative pain levels
Postoperative pain will be evaluated with the visual analog scale (VAS), the first analgesia requirement time will to be shown as "minute" and the total amount of analgesia consumed as "mg".

Full Information

First Posted
December 6, 2020
Last Updated
December 11, 2020
Sponsor
Selcuk University
search

1. Study Identification

Unique Protocol Identification Number
NCT04671992
Brief Title
Out Of-plane Technique Against In-plane for Caudal Block
Official Title
Ultrasound Guided Out Of-Plane Technique Against İn-Plane Technique for Caudal Block in Pediatric Hypospadias Surgery: A Prospective Randomized Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Anticipated)
Study Completion Date
April 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Caudal block is an easy and effective type of central neuraxial block that is widely used in subumbilical surgeries to provide intraoperative and postoperative analgesia in the pediatric population. Caudal block application with ultrasound (USG) was first applied in 2003. Sacrum, sacral cornular, sacrococcygeal ligament and sacral hiatus can be easily distinguished by ultrasound. The probe is positioned in a horizontal midline position on the lower sacrum. Sacral roots within the caudal epidural space can be seen as hypoechoic ellipses. In addition, anatomical variations of the sacral hiatus and the process area can be clearly observed. A accurate probe use with ultrasound guided is confirmed by advancing the caudal needle in the desired direction, widening in the sacral hiatus with local anesthetic injection, and the turbulence observed during injection into the sacral canal if the color doppler feature is used. Thus, a decrease in complications and an increase in the success of the procedure can be achieved with simultaneous imaging. In addition, in cases where the block is difficult, the in-plane technique can be preferred in the midline plane.The aim of this study is to compare the success rates and postoperative pain levels of caudal block applications with the out of plane technique (probe applied by holding horizontal) and in-plane technique (probe applied vertically), which is routinely applied with ultrasound in pediatric hypospadias surgery.
Detailed Description
This study will be scheduled between January - March 2021 at Selcuk University Department of Anesthesiology and Reanimation. A total of 70 patients from American Society of Anesthesiologists classification physical status of (ASA-PS) I-II, aged 6 months to 10 years, will be included in the study. Routine monitoring electrocardiogram (ECG), peripheral oxygen saturation (SpO2) and non-invasive blood pressure measurements will be made to patients into the operating room, and their basal levels will be recorded. All patients were transferred to the operating room without premedication. The patients will be assigned to two groups as in-plane technique (Group IP) and out of-plane technique (Group OP) according to the program randomization list. Routine anesthesia induction will be performed with 7-8% sevoflurane, 100% oxygen until the patient loses consciousness with a face mask. Then, vascular access will be established and propofol 2-3 mg for general anesthesia induction. kg 1 and fentanyl 1 μg. kg-1 IV will be used. After the eyelash reflex disappears without any neuromuscular blocker medication, a suitable laryngeal mask airway device will be placed into supraglottic area, and the patient will be connected to the anesthesia device for ventilation. For the maintenance of anesthesia, 2% sevoflurane, nitrous oxide will be stopped, and 50% oxygen + air mixture will be used. For caudal epidural block, the patient will be turned to the lateral position. After the asepsis of the perianal region is achieved, the sterile 8-18 MHz lineer USG probe for Group OP will be placed transversely in the midline to obtain a transverse view in the sacral hiatus. For group IP, the probe will be rotated 90 degrees and applied with the in-plane technique. After it is observed that there is no blood or cerebrospinal fluid (CSF) with aspiration, local anesthetic (LA) injection will be performed under hemodynamic and ECG monitoring by calculating the dose as 0.5 mg.kg-1 (0.25% bupivacaine) and the volume as 0.5 ml.kg-1. A successful block will be defined as the absence of significant motor movements after surgical induction, after heart and respiratory rates do not increase up to 20% above basal levels. In addition, block application time, number of needle attempts, success at first entry, ease of visualization, LA spread will be recorded and evaluated as the success rate. In both groups, the surgical caudal block will begin 10 minutes after anesthesia. Intraoperative opioids or sedative drugs will not be used. Mean arterial pressure, heart rate and oxygen saturation of the patients will be recorded every 5 minutes. At the end of the surgery, patients will be extubated and followed up in the postoperative recovery unit. Postoperative pain 10 minutes, 30 minutes, 1st, 2nd, 3rd, 6th, 12th, 24th hours FLACC pain scale (Face Legs Activity Cry Consolabity = face , legs, activity, crying, consolation). Time to first analgesia requirement, total analgesic consumption and postoperative complications will be recorded. In the evaluations made to patients in both groups, if the FLACC scale is> 4, rescue analgesia will be administered intravenously with 15 mg.kg-1 paracetamol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ultrasound Imaging, Caudal Block, Hypospadias

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound Guided Out of-Plane Technique
Arm Type
Active Comparator
Arm Description
Ultrasound Guided Out of plane technique (probe applied by holding horizontal)
Arm Title
Ultrasound Guided In-Plane Technique
Arm Type
Active Comparator
Arm Description
Ultrasound Guided Out of plane technique (probe applied by holding vbertical)
Intervention Type
Device
Intervention Name(s)
Out of-Plane Technique and In-Plane on
Intervention Description
A comparison of out of-plane technique and in-plane
Primary Outcome Measure Information:
Title
the success rates of in-plane and out of-plane techniques
Description
To measure success rates of in-plane and out-of-plane techniques for caudal block, the number of successful processing and the time of processing (minute) will be used
Time Frame
4 months
Secondary Outcome Measure Information:
Title
The postoperative pain levels
Description
Postoperative pain will be evaluated with the visual analog scale (VAS), the first analgesia requirement time will to be shown as "minute" and the total amount of analgesia consumed as "mg".
Time Frame
4 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pediatric patients undergoing hypospadias surgery ASA PS I-II group Exclusion Criteria: Previous neurological or spinal disorder, Coagulation anomaly Allergy to local anesthetics Local infection in the block area Children with a history of preterm birth
Facility Information:
Facility Name
Selcuk University, School of Medicine
City
Konya
ZIP/Postal Code
42080
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
I do not have a plan to make individual participant data (IPD) available to other researchers.

Learn more about this trial

Out Of-plane Technique Against In-plane for Caudal Block

We'll reach out to this number within 24 hrs