US_epidural: Ultrasound Epidural Technique

Sponsor

Mansoura University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05331157

Collaborator

(none)

110

Enrollment

Location

Arms

Anticipated Duration (Months)

12.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pediatric- Epidural Analgesia -Palpation-ultrasound	Device: ultrasound	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

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

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jan 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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 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 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 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
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
Incidence of intraoperative tachycardia (as increase in heart rate by more than 20% from the basal) [allover the surgery (minutes)]
beat per minutes
The procedure time [minutes]
from the needle insertion into the skin till entering the epidural space
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University-Emergency hospital-ICU	Mansoura		Egypt

Sponsors and Collaborators

Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

maha abou-zeid, Assistant Professor of Anesthesia and Surgical Intensive Care, Mansoura University

ClinicalTrials.gov Identifier:

NCT05331157

Other Study ID Numbers:

Ultrasound epidural

First Posted:

Apr 15, 2022

Last Update Posted:

Jun 23, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 23, 2022