Erector Spinae Plane Block in Scoliotic Adolescents
NCT03968146 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2019-12-03
Summary
For scoliotic surgeries, Erector Spinae Plane Block (ESPB) can add to the multimodal approach for perioperative pain management with decreasing the opioids requirement, improving recovery and decreasing ICU stay.
Conditions
- Scoliosis Idiopathic
- Scoliosis; Adolescence
- Erector Spinae Plane Block
Interventions
- PROCEDURE
-
Erector Spinae Plane Block
The linear multi-frequency 6-13 megahertz transducer will be used. In the prone position,under aseptic conditions, the probe will be placed in a longitudinal position 2-3 cm lateral to the vertebral column. The transverse processes of the vertebrae at (mid) level of surgery, the Erector Spinae muscle and the psoas muscle are identified. A 22 gauge echogenic needle will be inserted in an in plane technique in a cephalad to caudad direction until bone contact with the top of the transverse process is reached. After slight retraction of the needle, A test dose of 5% dextrose in water can expand the fascial plane and confirm needle-tip location prior to injection of local anaesthetic. Then, 0.5 ml/kg of bupivacaine 0.25% with 0.1 mg/kg dexamethasone and adrenaline 1 : 200000 will be injected between erector spinea muscle and transverse process, taking in consideration not exceeding the toxic dose of bupivacaine; 4 mg/kg . the same procedure will be repeated on the contralateral side.
- DRUG
-
patients will receive an induction dose at 1 mcg/kg. If the analgesia was inadequate in the form of increase in heart rate and or arterial blood pressure by more than 20% of baseline values during surgery, this warrants the administration of intravenous fentanyl (0.5µg/kg).
- DRUG
-
additional Fentanyl
patients will receive another dose of fentanyl 1 µg/kg 1 minute before start of skin incision.
- DRUG
-
Morphine
After end of surgery and emergence from anesthesia, patients will receive continuous intravenous morphine with 0.03 mg/kg/hr.
- DRUG
-
rescue Morphine
Morphine IV will be given as rescue analgesia (20 µg/kg) in all study groups if VAS pain score more than 3. The total maximum hourly morphine is 0.75 mg/kg/hr.
- DRUG
-
pethidine
After reaching maximum hourly morphine and the patient is still in pain, pethidine will be used as a rescue at 0.5 mg/kg.
- DRUG
-
Ketorolac
patients will receive IV ketorolac from the postoperative second day 15 mg q 6 hours, not to exceed 5 days.
- DRUG
-
patients will receive postoperative IV acetaminophen IV 10 mg/ kg q 6 hours
Sponsors & Collaborators
-
Kasr El Aini Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 8 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-06-18
- Primary Completion
- 2019-11-05
- Completion
- 2019-12-02
Countries
- Egypt
Study Locations
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