Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06162806 |
Other study ID # |
MS-454-2022 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 14, 2023 |
Est. completion date |
March 6, 2024 |
Study information
Verified date |
March 2024 |
Source |
Cairo University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
this is a randomized controlled study ,patients will be randomly divided into 2 groups ,
Group A will receive caudal block using 1ml/kg Bupivacaine +0.5u/kg fentanyl, Group B will
receive caudal block 50 mg magnesium sulfate added to (1ml/kg Bupivacaine +0.5u/kg fentanyl)
Description:
A total of 50 pediatric patients undergoing lower abdominal urological surgeries will be
enrolled in this prospective randomized controlled (RCT) study.
I- Randomization:
All included subjects will be randomly allocated and will be divided into two groups; (Group
A): will receive [Fentanyl / Bupivacaine], and (Group B): will receive magnesium sulfate
added to the previous bi-mixture [Fentanyl / Bupivacaine]. Using computer generated number
and concealed using sequentially numbered, sealed opaque envelope technique. There will be no
restrictions or stratification in the randomization process. The allocation envelope will be
opened by the assistant lecturer at the time of anesthetic preparation. Also, the drug
preparation will be conducted by an anesthetist who will not involve in any of the study
collection data. Finally, the data will be analyzed on an intention-to-treat basis and
included all patients who were randomly assigned.
II- Study protocol
1. Pre-operative preparation All children will be anaesthetized in accordance with the
local policy of the Abou El-Resh pediatric hospital-Cairo University's pediatric
anesthetic unit. Except for oral clear fluid intake 2 hours before surgery, all children
will fast for 6 hours. Patients will attend in the preparation room one hour before the
operation to get a preoperative checkup, their age and body weight will be recorded as
well.
2. Intra-operative management
Premedication by intramuscular injection of atropine 0.02 mg/Kg and midazolam 0.2 mg/Kg will
be followed by insertion of intravenous (I.V) cannula.
General anesthesia will be induced in supine position under standard basic monitoring of
vital signs with inhalational anesthetic using (100%) O2 + Sevoflurane. After deepening of
the anesthesia, atracurium 0.5mg/kg and fentanyl 1μg/kg patients will be given, Endotracheal
intubation will then follow by appropriate size of endotracheal tube. volume control
ventilation (VCV) 5-7 ml/kg and respiratory rate will be adjusted to keep and PaCO2 levels
between 30-35 mmHg using (G.E-Datex-Ohmeda, Avance CS2, USA) anesthesia machine. Anesthesia
will be maintained with isoflurane 1 MAC with 50% oxygen in air, and atracurium top-ups of
0.1mg/kg will be given every 30 minutes for neuromuscular blockade.
Technique
After induction of anesthesia, each child will be placed in the left decubitus position with
hips flexed at 90 degrees, under complete aseptic precautions, disinfecting the back with
chlorhexidine and alcohol, then identification of sacral hiatus is attempted by palpation.
By the aid of US, using a linear transducer placed transversely at the midline to obtain the
transverse view of sacral hiatus. Between the sacral cornua are two band-like hyperechoic
structures; the superficial one is the SCL, and the deep one is the dorsal surface of sacral
bone. The sacral hiatus is the hypoechoic region between the 2 band-like hyperechoic
structures. At this level, the ultrasound transducer is rotated 90 degrees to obtain the
longitudinal view of sacral hiatus.
Under longitudinal view, the block needle is inserted using the "in-plane" technique. it is
suggested that advancement of needle tip beyond the apex of sacral hiatus be limited to 5 mm
to avoid dural puncture because the distance between the apex of sacral hiatus and dural sac
termination can be as short as less than 6 mm. [8]
(Group A):
Patients in this anesthetic group will receive 0.5 µ/kg fentanyl + 1ml/kg Bupivacaine 0.25%
(Group B): Patients in this anesthetic group will receive 50 mg magnesium added to the (0.5
µ/kg fentanyl +1ml/kg Bupivacaine 0.25%) Bi-mixture.
After receiving caudal block the patient will be turned to the supine position and surgical
incision will be allowed to be done after 15 minutes.
Continuous recording of heart rate, blood pressure, oxygen saturation and respiratory rate
will be carried out from the moment of injection at timely intervals intraoperative. Pain
assessment using FLACC score will then follow till 12 hours post-operative.
The time passed between the entrance of the needle into the skin and the injection's
completion is referred to as caudal block performance time.
If there is an increase in heart rate or mean arterial pressure of 20% of the baseline values
after skin incision, then it will be considered as a failed block and these patients will be
excluded from the study and fentanyl of 1µ/kg will be given to provide analgesia