Ultrasound Epidural Technique (US_epidural)

Ultrasonically Versus Conventional Palpation for Epidural Analgesia in Pediatrics Undergoing Midabdominal Urological Operations

Epidural analgesia for abdominal surgeries provides numerous advantages for both neonates and children. The anatomical identification of the intervertebral space to access the epidural space is not constantly easy this is due uncertainty of the direction of the needle angle and the difficulty to estimate the epidural depth in spite of the skill of the operator. This can lead to more puncture attempts, inducing more pain or discomfort and even failure of epidural access.

Pre-procedure neuraxial ultrasound (US) imaging facilities the identification of the chosen intervertebral space, the depth of the epidural space and so the selection of best point and angle for the needle insertion

Study Overview

• Status: Completed
• Conditions: Pediatric- Epidural Analgesia -Palpation-ultrasound
• Intervention / Treatment: Device: ultrasound

Detailed Description

The aim of this study is to evaluate the efficacy of prepuncture ultrasonography to facilitate epidural block in pediatric patients undergoing elective urological operations compared with the conventional anatomical landmark technique

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • Mansoura University-Emergency hospital-ICU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pediatric patients aged from 1 to 12 years old
• Both genders
• American Society of Anesthesiologists (ASA) physical status I,II, III
• Scheduled for open midabdominal urological surgeries under general anesthesia

Exclusion Criteria:

• Pediatric patients aged less than 1 or more than 12 years old
• American Society of Anesthesiologists (ASA) physical status Iv
• Parents' refusal to participate in the study
• Any contraindication to epidural block (as severe infection at the puncture site, coagulopathy or hemodynamically unstable patients)
• Neuromuscular diseases
• Severe spinal deformity
• History of allergy to the anesthetic drugs

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: palpation group; In lateral decubitus position, the conventional palpation technique will be used to detect the epidural space. The midline will be identified by palpation of the spinous processes. Through the Tuffier's line, L5 spine then, the two intervertebral spaces (L3-4 and L2-3) will be detected and the middle of each intervertebral space will be marked with selection of the widest space. After sterilization of the patient's skin the needle will be inserted to detect the epidural space by using loss of resistance to saline
Experimental: Ultrasonography group; In lateral decubitus position, a curved array probe will be utilized to scan the sacrum in the longitudinal paramedian plane, then the probe will be moved upwards to detect the L5-S1, L4-5, L3-4 and L2-3 intervertebral spaces then turned 90º to the transverse plane and used to scan L3-4 and L2-3 spaces inside the 2 spaces, midline will be detected by noting the site of spinous processes with selection of the space with the best sonographic image quality. Then skin surface at the middle of the long and short axis of the probe will be marked horizontally. If the 2 spaces have the same image quality, L2-3 space will be chosen for the entrance of epidural needle. After sterilization of the patient's skin the needle will be inserted to detect the epidural space by using loss of resistance to saline	Device: ultrasound; the efficacy of prepuncture ultrasonography to facilitate epidural block in pediatric patients undergoing elective urological operations compared with the conventional anatomical landmark technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of a successful reaching to the epidural space from the first needle pass	incidence after insertion of the epidural needle into the skin till reaching the epidural space	minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of a successful reaching to the epidural space from the first skin puncture	incidence after insertion of the epidural needle into the skin till reaching the epidural space	minutes
The number of performed skin punctures by the epidural needle	number after insertion of the epidural needle into the skin till reaching the epidural space	minutes
The number of needle passes from the same skin puncture required for reaching the epidural space	number from the skin puncture done by the epidural needle till removing the epidural needle from this the skin puncture	minutes
The epidural space demarcation time by the ultrasound	The time from placing the ultrasound probe on the skin until the skin marking is completed at L3-4 and L2-3 space	minutes
The epidural space demarcation time by the landmark	The time from start skin palpation til the skin marking is completed at L3-4 and L2-3 space	minutes
The procedure time which is the time from the needle insertion into the skin until reaching the epidural space		minutes
Incidence of intraoperative hypertension (as increase in systolic blood pressure (SBP) by more than 20% from the basal)	mmHg	allover the surgery (minutes)
Incidence of intraoperative tachycardia (as increase in heart rate by more than 20% from the basal)	beat per minutes	allover the surgery (minutes)
The procedure time	from the needle insertion into the skin till entering the epidural space	minutes
pain score using "face, leg, activity, cry, consolability" (FLACC) scale	five criteria, which are each assigned a score of 0, 1 or 2	30 minutes after the patient has transferred to the recovery room

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): September 20, 2023

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: April 10, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Ultrasound epidural

Drug and device information, study documents

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