Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04671992 |
| Other study ID # |
farukcicekci3 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2020 |
| Est. completion date |
April 15, 2021 |
Study information
| Verified date |
December 2020 |
| Source |
Selcuk University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
