An interventional study of Sacral ESP block and Caudal block in Analgesia, sponsored by Sameh Fathy. Completed at 1 site in Egypt. Open to participants aged 1 Year to 7 Years. Per ClinicalTrials.gov, last updated 2022-07-07.
Sponsored by Sameh Fathy · Not applicable, Interventional, and Treatment
This study will be conducted to evaluate efficacy of ultrasound guided sacral erector spinae plane block for postoperative analgesia in pediatric anorectal surgery in comparison to caudal block.
Regional anesthesia in children has become increasingly popular over the past few decades. A variety of peripheral and central nerve blocks have been developed to ensure that perioperative pain can be effectively controlled. So, it possible to reduce the dose concentrations of systemic drugs and improved hemodynamic stability in high-risk patients. Erector spinae plane (ESP) block with various approaches been used in many surgeries and obtained great popularity despite of its novelty. After first description; lower thoracic, lumbar and sacral approaches were defined for postoperative analgesia. There are a few cases in which sacral ESP block was administered and reported.
The aim of this study is to compare postoperative analgesic effect of ultrasound guided sacral ESP block and caudal block. It is hypothesized that sacral ESP block will be comparable to caudal block as a promising effective alternative for analgesia in patients who will undergo pediatric anorectal surgery with fewer side effects.
This prospective, randomized, comparative clinical study will include 60 children who will be scheduled for elective anorectal surgery under general anesthesia in Mansoura university hospitals. Informed written consent will be obtained from parents of all subjects in the study after ensuring confidentiality. The study protocol will be explained to parents of all patients in the study who will be kept fasting prior to surgery. Patients will be randomly assigned to two equal groups (ESP and caudal) according to computer-generated table of random numbers using the permuted block randomization method. The collected data will be coded, processed, and analyzed using SPSS program. All data will be considered statistically significant if P value is ≤ 0.05.
Sameh Fathy is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Ultrasound guided sacral erector spinae plane (ESP) block will be performed in the lateral position under sterile conditions, and bupivacaine will be administered.
Procedure: Sacral ESP block · Drug: Bupivacaine Hydrochloride
Ultrasound guided caudal block will be performed in the lateral position under sterile conditions, and bupivacaine will be administered.
Procedure: Caudal block · Drug: Bupivacaine Hydrochloride
A high-frequency ultrasound linear probe covered with a sterile sheath will be placed longitudinally to the midline of the sacrum. The median sacral crests and erector spinae muscle will be visualized, then a 22-gauge, 50 mm needle will be advanced from cranial to caudal direction until its tip touch the sacral crest.
Also known as: Ultrasound guided approach
A high-frequency ultrasound linear probe covered with a sterile sheath will be placed on to the sacrococcygeal region. The dura mater, epidural space, conus medullaris, sacral cornua, and sacrococcygeal ligament will be identified. Using the in-plane technique, a 22-gauge, 50 mm needle will be introduced to reach the sacral epidural space.
Also known as: Ultrasound guided approach
Following negative aspiration, a precalculated dose (0.5 ml/kg) of 0.25% bupivacaine will be injected.
Also known as: Marcaine
Duration for the first analgesic request
The time of the first analgesic request for paracetamol in minutes will be recorded.
Time frame: Up to 24 hours after the procedure
Total analgesic requirements of paracetamol
The amount of paracetamol consumption in milligrams given as a rescue analgesia
Time frame: Up to 24 hours after the procedure
Improvement in pain scores
Pain score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) is assessed postoperatively at 1, 2, 4, 8, 12, 24 hours
Time frame: Up to 24 hours after the procedure
Changes in heart rate
Heart rate (beat/min) is recorded at ten-minute intervals until the end of the surgery.
Time frame: Up to end of the surgery
Changes in mean arterial blood pressure
Blood pressure (mmHg) is recorded at ten-minute intervals until the end of the surgery.
Time frame: Up to end of the surgery
Changes in postoperative emergence agitation scale
Agitation is assessed using the 5- step Cravero scale (1-5) every five minutes from awakening and for 30 minutes.(1:Obtunded with no response to stimulation, 2:Asleep but responsive to movement or stimulation, 3:Awake and responsive, 4:Crying, 5:Thrashing behaviour that requires restraint)
Time frame: Up to 30 minutes after the procedure
Value of parent satisfaction from the procedure
The parents will be investigated postoperatively for the quality of the procedure verbally (0-10; 0=None, 10=total satisfaction)
Time frame: Up to 24 hours after the procedure
Plan to share: No
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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Sameh Fathy