Clinical trial NCT05331157: Ultrasound Epidural Technique
Official title: Ultrasonically Versus Conventional Palpation for Epidural Analgesia in Pediatrics Undergoing Midabdominal Urological Operations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric- Epidural Analgesia -Palpation-ultrasound
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 110
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: the rate of a successful reaching to the epidural space from the first needle pass
timeFrame: minutes
Secondary outcomes:
measure: the rate of a successful reaching to the epidural space from the first skin puncture
timeFrame: minutes
measure: The number of performed skin punctures by the epidural needle
timeFrame: minutes
measure: The number of needle passes from the same skin puncture required for reaching the epidural space
timeFrame: minutes
measure: The epidural space demarcation time by the ultrasound
timeFrame: minutes
measure: The epidural space demarcation time by the landmark
timeFrame: minutes
measure: The procedure time which is the time from the needle insertion into the skin until reaching the epidural space
timeFrame: minutes
measure: Incidence of intraoperative hypertension (as increase in systolic blood pressure (SBP) by more than 20% from the basal)
timeFrame: allover the surgery (minutes)
measure: Incidence of intraoperative tachycardia (as increase in heart rate by more than 20% from the basal)
timeFrame: allover the surgery (minutes)
measure: The procedure time
timeFrame: minutes
measure: pain score using "face, leg, activity, cry, consolability" (FLACC) scale
timeFrame: 30 minutes after the patient has transferred to the recovery room
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University-Emergency hospital-ICU
Study officials:
References: