Ultrasound Guided Sacral Erector Spinae Plane Block in Pediatric Anorectal Surgery

Sameh Fathy

Status: Completed

Conditions: Analgesia

Treatments: Drug: Bupivacaine Hydrochloride; Procedure: Sacral ESP block; Procedure: Caudal block

Study type: Interventional

Funder types: Other

Identifiers

NCT04921007

Sacral ESP Block

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 1 to 7 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Group (A) Sacral ESP block

Active Comparator group

Description:

Ultrasound guided sacral erector spinae plane (ESP) block will be performed in the lateral position under sterile conditions, and bupivacaine will be administered.

Treatment:

Drug: Bupivacaine Hydrochloride

Procedure: Sacral ESP block

Group (B) Caudal block

Active Comparator group

Description:

Ultrasound guided caudal block will be performed in the lateral position under sterile conditions, and bupivacaine will be administered.

Treatment:

Procedure: Caudal block

Drug: Bupivacaine Hydrochloride