Ultrasound Guided Sacral Erector Spinae Plane Block in Pediatric Anorectal Surgery

Analgesic Efficacy of Ultrasound Guided Sacral Erector Spinae Plane Block Versus Caudal Block in Pediatric Anorectal Surgery

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.

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Procedure: Sacral ESP block; Drug: Bupivacaine Hydrochloride; Procedure: 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35511
      • Department of Anesthesia, Mansoura University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group (A) Sacral ESP block; 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; 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.; Other Names: Ultrasound guided approach; Drug: Bupivacaine Hydrochloride; Following negative aspiration, a precalculated dose (0.5 ml/kg) of 0.25% bupivacaine will be injected.; Other Names: Marcaine
Active Comparator: Group (B) Caudal block; Ultrasound guided caudal block will be performed in the lateral position under sterile conditions, and bupivacaine will be administered.	Drug: Bupivacaine Hydrochloride; Following negative aspiration, a precalculated dose (0.5 ml/kg) of 0.25% bupivacaine will be injected.; Other Names: Marcaine; Procedure: Caudal block; 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.; Other Names: Ultrasound guided approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration for the first analgesic request	The time of the first analgesic request for paracetamol in minutes will be recorded.	Up to 24 hours after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total analgesic requirements of paracetamol	The amount of paracetamol consumption in milligrams given as a rescue analgesia	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	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.	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.	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)	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)	Up to 24 hours after the procedure

Collaborators and Investigators

• Sponsor: Sameh Fathy

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2021
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 8, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 5, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Erector spinae plane block; Ultrasound guided; Sacral; Anorectal surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: Sacral ESP Block

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No