Erector Spinae Plane Block for Paediatric Upper Abdominal Surgery
NCT ID: NCT04518215
Last Updated: 2023-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2020-08-20
2022-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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ESPB group
Erector Spinae Plain Block
Erector Spinae Plain Block
Patients will receive erector spinae plane block (ESP) at the level of T 9-10. Following skin sterilization, high-frequency linear ultrasound probe will be placed 1-2 cm lateral to the midline at the T 9 level. After identification of the erector spinae muscle (ESM) and the transverse process; a 22 G needle will be inserted, in a cranio-caudal direction, deep into the ESM in an in-plane technique. Correct needle placement will be verified with the administration of 0.5-1 ml Normal Saline to view the hydrodissection between the transverse process and the ESM. 0.25% Bupivacaine in a calculated volume of 0.5 ml/kg (with a maximum dose of 20 ml) will be injected deep to the erector spinae muscle for unilateral ESPB.
Intra-Venous Analgesia
Post-operative rescue analgesic plan will consist of 15 mg/kg Paracetamol IV if the FLACC \[Face, Leg, Activity, Cry, Consolability\] score is 2-4 and 1 mg/kg Tramadol IV if FLACC score \> 4.
IV Analgesia group
Intra-Venous Analgesia
Intra-Venous Analgesia
Post-operative rescue analgesic plan will consist of 15 mg/kg Paracetamol IV if the FLACC \[Face, Leg, Activity, Cry, Consolability\] score is 2-4 and 1 mg/kg Tramadol IV if FLACC score \> 4.
Interventions
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Erector Spinae Plain Block
Patients will receive erector spinae plane block (ESP) at the level of T 9-10. Following skin sterilization, high-frequency linear ultrasound probe will be placed 1-2 cm lateral to the midline at the T 9 level. After identification of the erector spinae muscle (ESM) and the transverse process; a 22 G needle will be inserted, in a cranio-caudal direction, deep into the ESM in an in-plane technique. Correct needle placement will be verified with the administration of 0.5-1 ml Normal Saline to view the hydrodissection between the transverse process and the ESM. 0.25% Bupivacaine in a calculated volume of 0.5 ml/kg (with a maximum dose of 20 ml) will be injected deep to the erector spinae muscle for unilateral ESPB.
Intra-Venous Analgesia
Post-operative rescue analgesic plan will consist of 15 mg/kg Paracetamol IV if the FLACC \[Face, Leg, Activity, Cry, Consolability\] score is 2-4 and 1 mg/kg Tramadol IV if FLACC score \> 4.
Eligibility Criteria
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Inclusion Criteria
* Elective open upper abdominal surgeries, e.g., open cholecystectomy, splenectomy, pyeloplasty, renal cysts excision, partial or total nephrectomy.
Exclusion Criteria
* Allergy to local anaesthetics.
* Infection at the site of injection.
* Coagulopathy.
2 Years
12 Years
ALL
No
Sponsors
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Nazmy Edward Seif
OTHER
Responsible Party
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Nazmy Edward Seif
Clinical Professor
Principal Investigators
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Atef K Salama, MD
Role: PRINCIPAL_INVESTIGATOR
Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
Nazmy S Michael, MD
Role: STUDY_DIRECTOR
Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
Locations
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Cairo University Hospitals
Cairo, , Egypt
Countries
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Other Identifiers
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USESPBPUAS
Identifier Type: -
Identifier Source: org_study_id
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