Ultrasound Epidural Technique

Not Applicable

Completed

• Conditions: Pediatric- Epidural Analgesia -Palpation-ultrasound
• Interventions: Device: ultrasound

• Registration Number: NCT05331157
• Lead Sponsor: Mansoura University

Brief Summary

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-04-10
• Study First Posted: 2022-04-15
• Study Start: 2022-05-01
• Primary Completion: 2023-08-01
• Study Completion: 2023-09-20
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-19
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasonography group	ultrasound	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

Primary Outcome Measures

Name	Time	Method
the rate of a successful reaching to the epidural space from the first needle pass	minutes	incidence after insertion of the epidural needle into the skin till reaching the epidural space

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mansoura University-Emergency hospital-ICU; 🇪🇬 Mansoura, Egypt