Ultrasonically Versus Conventional Palpation for Epidural Analgesia in Pediatrics Undergoing Midabdominal Urological Operations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- the rate of a successful reaching to the epidural space from the first needle pass
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- 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
Eligibility Criteria
- Ages
- 1 Year to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
the rate of a successful reaching to the epidural space from the first needle pass
Time Frame: minutes
incidence after insertion of the epidural needle into the skin till reaching the epidural space
Secondary Outcomes
- The number of performed skin punctures by the epidural needle(minutes)
- The procedure time(minutes)
- Incidence of intraoperative tachycardia (as increase in heart rate by more than 20% from the basal)(allover the surgery (minutes))
- the rate of a successful reaching to the epidural space from the first skin puncture(minutes)
- The epidural space demarcation time by the ultrasound(minutes)
- The epidural space demarcation time by the landmark(minutes)
- The number of needle passes from the same skin puncture required for reaching the epidural 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)(allover the surgery (minutes))
- pain score using "face, leg, activity, cry, consolability" (FLACC) scale(30 minutes after the patient has transferred to the recovery room)
Investigators
maha abou-zeid
Assistant Professor of Anesthesia and Surgical Intensive Care
Mansoura University