Erector Spinae Plane Block Clinical Trial
Official title:
Analgesic Efficacy of Ultrasound Guided Erector Spinae Plane Block Versus Fentanyl Infusion in Pediatric Patients Undergoing Aortic Coarcitectomy. a Randomized Controlled Study.
Verified date | July 2022 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pain is considered to be subjective, however in children it is believed to be felt rather than expressed, because they often depend on the caregiver for their safety and well-being. There is significant pain after thoracotomy surgery because of pleural and muscular damage, ribcage disruption, and intercostal nerve damage during surgery, which if not effectively managed, it will lead to various systemic complications; pulmonary (atelectasis, pneumonia, and stasis of bronchial secretions), cardiovascular (increased oxygen consumption and tachycardia), musculoskeletal (muscle weakness), increased neuro-hormonal response and prolonged hospital stay. So adequate and sufficient post-operative analgesia for paediatric patients is mandatory. The use of highly potent opioids for paediatric cardiac anaesthesia has gained widespread popularity during the last 20 years.In addition to the important advantage of hemodynamic stability, the large-dose opioid-based anaesthetic techniques also blunt the stress response, However, large doses can cause oversedation, respiratory depression, and prolonged mechanical ventilation after surgery. Erector Spinae Plane Block (ESPB), recently developed by Forero et al, is a novel technique in management of thoracic neuropathic pain guided by ultrasound. It became popular because it is much safer and easily administered than other alternative regional techniques as thoracic paravertebral and thoracic epidural block. To our knowledge, Erector Spinae Plane Block (ESPB) performed in aortic coarcitectomy operations has not been investigated yet.This has encouraged the performance of the present study.
Status | Completed |
Enrollment | 28 |
Est. completion date | July 30, 2021 |
Est. primary completion date | July 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 12 Months |
Eligibility | Inclusion Criteria: 1. Age: 3 months-12 months. 2. A III . 3. Patients undergoing aortic coarcitectomy operation undergone with Lateral thoracotomy incision. Exclusion Criteria: 1. Patients whose parents or legal guardians refusing to participate. 2. Preoperative mechanical ventilation. 3. Preoperative inotropic drug infusion. 4. Patients undergoing aortic coarctectomy operation undergone with midline sternotomy incision. 5. Known or suspected coagulopathy. 6. Any congenital anomalies of the sacrum/the vertebral column or any infection at the site of injection. 7. Known or suspected allergy to any of the studied drugs. 8. Elevated liver enzymesmore than the normal values. 9. Renal function impairment (Creatinine value more than 1.2mg/dl or blood urea nitrogen more than 20mg/dl). |
Country | Name | City | State |
---|---|---|---|
Egypt | Kasr Al-Ainy Hospital | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The total dose of intraoperative fentanyl boluses. | microgram/kg | From skin incision till 5 minutes after skin closure | |
Secondary | Face, Leg, Activity, Cry, Consolability | Face
0: if patient has a relaxed face 1: if patient has a worried look ,eyes partially closed, mouth pursed 2: if patient has deep furrows in the forehead, with closed eyes, open mouth. Legs 0: if patient has usual tone and motion to limbs. 1: if patient has increase tone, rigidity. 2: if patient has hyper tonicity, legs pulled tight, exaggerated flexion/extension of limbs. Activity 0: if patient moves easily and freely. 1: if patient shifts positions, guarding. 2:if patient is in fixed position, side-to-side head movement. Cry 0: if patient has no cry/moan awake or asleep 1: if patient has occasional moans, cries. 2: if patient has frequent/continuous moans, cries, grunts. Consolability 0: if patient is calm and does not require consoling 1: if patient responds to comfort by touch or talk in ½- 1 minute 2: if patient requires constant comforting or unable to console. |
30 min, 60 min, 2 hours, 4hours, 8hours, 16hours and 24 hours postoperatively | |
Secondary | postoperative Morphine | mg/kg | 30 minutes postoperative till 24 hours postoperative |
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