Ultrasound Epidural Technique

NCT05331157 | Completed

• 1 other identifier: Ultrasound epidural
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Conditions

Pediatric- Epidural Analgesia -Palpation-ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• the rate of a successful reaching to the epidural space from the first skin puncture

  minutes

• The number of performed skin punctures by the epidural needle

  minutes

• The number of needle passes from the same skin puncture required for reaching the epidural space

  minutes

• The epidural space demarcation time by the ultrasound

  minutes

• The epidural space demarcation time by the landmark

  minutes

Study Arms (2)

palpation group

NO INTERVENTION

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

Ultrasonography group

EXPERIMENTAL

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

Interventions

ultrasound DEVICE

the efficacy of prepuncture ultrasonography to facilitate epidural block in pediatric patients undergoing elective urological operations compared with the conventional anatomical landmark technique

Ultrasonography group

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University-Emergency hospital-ICU

Al Mansurah, Egypt

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients will be randomly assigned to 2 equal groups (ultrasonography and palpation; 55 subjects in each group) using the permuted block randomization method with randomly selected block sizes of 4 and 6. The group allocation codes were concealed in sequentially numbered, opaque, sealed envelopes that were opened only after assessing the eligibility and obtaining the consent from the parents
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia and Surgical Intensive Care

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 15, 2022
• Study Start: May 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: September 20, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

EG (1)