Conventional Caudal Block, Ultrasound Guided Caudal Block, Ultrasound Guided Erector Spinae Block, Pediatric Hip Surgery
Conditions
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.
Interventions
PROCEDUREConventional caudal block
Patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected in the caudal epidural space) by the conventional method (blind technique without ultrasound).
PROCEDUREUltrasound-guided caudal block
Using ultrasound, patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected in the caudal epidural space).
Under ultrasound guidance, patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the transverse process of the second lumbar vertebrae(L2).
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Both sex * ASA physical activity I, II * Age 4-12 years * Admitted for elective hip surgery.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Time to first rescue analgesic demand after surgery. | First 24 hours postoperative | measured from the end of surgery till patient require analgesia. |
| 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). |
| 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). |
| 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. |
Countries
Egypt
Contacts
Primary ContactEman Hamdy Abu-Shanab, MSc
Outcome results
None listed