Clinical trial NCT04921007: Ultrasound Guided Sacral Erector Spinae Plane Block in Pediatric Anorectal Surgery
Official title: Analgesic Efficacy of Ultrasound Guided Sacral Erector Spinae Plane Block Versus Caudal Block in Pediatric Anorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Keywords: Erector spinae plane block
Ultrasound guided
Sacral
Anorectal surgery
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology (ASA) I and II patients.
* Scheduled for pediatric anorectal surgery

Exclusion Criteria:

* Parental refusal of consent.
* Children with developmental delays, mental or neurological disorders.
* Bleeding or coagulation diathesis.
* History of known sensitivity to the used anesthetics.
* Infection or redness at the injection site.

Primary outcomes:
measure: Duration for the first analgesic request
timeFrame: Up to 24 hours after the procedure
Secondary outcomes:
measure: Total analgesic requirements of paracetamol
timeFrame: Up to 24 hours after the procedure
measure: Improvement in pain scores
timeFrame: Up to 24 hours after the procedure
measure: Changes in heart rate
timeFrame: Up to end of the surgery
measure: Changes in mean arterial blood pressure
timeFrame: Up to end of the surgery
measure: Changes in postoperative emergence agitation scale
timeFrame: Up to 30 minutes after the procedure
measure: Value of parent satisfaction from the procedure
timeFrame: Up to 24 hours after the procedure
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Department of Anesthesia, Mansoura University Hospitals
state: Dakahlia
Study officials:
affiliation: Mansoura Faculty of Medicine
name: Sameh M El-Sherbiny, MD
role: PRINCIPAL_INVESTIGATOR
References: