Conventional Caudal Block, Ultrasound Guided Caudal Block and Ultrasound Guided Erector Spinae Block for Pediatric Hip Surgery
- Conditions
- Ultrasound Guided Caudal BlockPediatric Hip SurgeryConventional Caudal BlockUltrasound Guided Erector Spinae Block
- Interventions
- Procedure: Conventional caudal blockProcedure: Ultrasound-guided caudal blockProcedure: Ultrasound guided erector spinae plane Block
- Registration Number
- NCT04712370
- Lead Sponsor
- Tanta University
- Brief Summary
This study will be conducted to compare the efficacy and safety of ultrasound guided erector spinae block , ultrasound guided caudal block and conventional caudal block for pain management after pediatric hip surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 105
- Both sex
- ASA physical activity I, II
- Age 4-12 years
- Admitted for elective hip surgery.
- Parents refusal
- Children with severe systemic disease
- ASA III or IV
- Children with previous neurological or spinal anomaly, coagulation disorders
- History of premature birth
- Infection at the block injection site
- History of allergy to local anesthetics
- Bilateral hip surgery.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional caudal block Conventional caudal block Patients of this group will receive the conventional method (blind technique without ultrasound) of caudal block Ultrasound-guided caudal block Ultrasound-guided caudal block Patients of this group will receive caudal block using ultrasound. Ultrasound guided erector spinae plane Block Ultrasound guided erector spinae plane Block Patients of this group will receive ultrasound guided erector spinae plane Block at the level of the transverse process of the second lumbar vertebrae(L2) .
- Primary Outcome Measures
Name Time Method Degree of pain intensity First 24 hours postoperative To evaluate the pain scores by (FLACC) scale. (FLACC) scale will be assessed after surgery over 24 hours where (0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 = Moderate pain ,7-10 = Severe discomfort /pain)
- Secondary Outcome Measures
Name Time Method Changes in mean arterial blood pressure Intraoperative and first 24 hours postoperative Mean arterial blood pressure will be recorded before block performance at T0, intraoperatively at 15 and 30 minutes, then every 30 min till the end of surgery and after surgery at T (0, 2, 4, 6, 12, 24 h).
Changes in heart rate Intraoperative and first 24 hours postoperative Heart rate will be recorded before block performance at T0, intraoperatively at 15 and 30 minutes, then every 30 min till the end of surgery and after surgery at T (0, 2, 4, 6, 12, 24 h).
Amount of Analgesic required in the first day after surgery First 24 hours postoperative The total dose of intravenous (IV) acetaminophen 15 mg/kg if FLACC scores between 2 and 4 at the first 24 h after surgery, and total dose of tramadol 1 mg/kg (IV) in case of FLACC score \> 4.
Duration of performing the block Intraoperative duration Block performing time is defined as the period between the insertion of the needle and termination of local anesthetic administration
Incidence of complications Intraoperative and first 24 hours postoperative Hypotension, bradycardia, postoperative nausea, vomiting, urinary retention, prolonged motor block, pruritus and local anesthetic systemic toxicity (LAST).
Time to first rescue analgesic demand after surgery. First 24 hours postoperative measured from the end of surgery till patient require analgesia.
Success rate of block Intraoperative duration a successful block is defined as absence of significant changes in heart rate following surgical induction. Heart rate increase is not\>20% of the basal levels. If the increase is\>20%, the block is accepted as unsuccessful.
Trial Locations
- Locations (1)
Tanta University Hospitals
🇪🇬Tanta, ElGharbiaa, Egypt