Serratus Anterior Plane Block in Pediatric Patients
- Conditions
- Anesthesia, Local
- Interventions
- Procedure: Serratus Anterior Plan Block+ Fentanyl infusion
- Registration Number
- NCT04444635
- Lead Sponsor
- Cairo University
- Brief Summary
The aim of this work is to study the efficacy of ultrasound guided serratus anterior plane block in pediatric patients undergoing thoracic surgeries.
It is a randomized controlled trial.
- Detailed Description
It is a prospective randomized controlled study. It is designed to estimate and compare the analgesic effect of single shot serratus anterior plane block in pediatric patients undergoing thoracic surgeries with fentanyl infusion versus fentanyl infusion alone as the control group. Our primary outcome will be the total dose of intra-operative fentanyl boluses.
Randomization will be achieved by using an online random number generator. Blindness will be achieved by patient codes which will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A physician not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anaesthesiologist who is expert in doing the serratus anterior plane block in patients included within the block group. This expert anaesthesiologist will not be involved in collecting data but another anaesthesia doctor will be responsible for patient management and collecting the intraoperative and postoperative data.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- Age: 6 months-3 years.
- American Society of anesthesiology (ASA) I and II.
- Pediatric patients undergoing thoracic surgeries (with anterior thoracotomy incision).
- Patients whose parents or legal guardians refusing to participate.
- Preoperative mechanical ventilation.
- Known or suspected coagulopathy.
- Infection at the site of injection.
- Known or suspected allergy to any of the studied drugs.
- Elevated liver enzymes more than the normal values.
- Procedures with anticipated significant hemodynamic stability.
- Renal function impairment (Creatinine value more than 1.2mg/dl or blood urea nitrogen (BUN) more than 20mg/dl).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Serratus Anterior Plan block plus fentanyl infusion Serratus Anterior Plan Block+ Fentanyl infusion The patients will receive serratus anterior block in addition to continous intraoperative fentanyl infusion. Serratus Anterior Plan block plus fentanyl infusion Fentanyl The patients will receive serratus anterior block in addition to continous intraoperative fentanyl infusion. Fentanyl infusion only Fentanyl The patient will receive fentanyl infusion only.
- Primary Outcome Measures
Name Time Method The total dose of postoperative operative fentanyl consumption in the first 24 hours. 12 months The total dose of postoperative operative fentanyl consumption in micrograms in the first 24 hours will be calculated
- Secondary Outcome Measures
Name Time Method Pain assessment postoperatively by Face, Leg, Activity, Cry, Consolability (FLACC) score, minimum is zero, and maximum is 6. 12 months Pain assessment at 30 min, 60 min, 2 hours, 4hours, 8hours postoperatively by FLACC score.
Intraoperative and postoperative systolic blood pressure. 12 months Intraoperative and postoperative systolic blood pressure.
Total dosage of additional fentanyl boluses usage in micrograms intraoperatively 12 months Total dosage of additional fentanyl boluses usage in micrograms intraoperatively
First rescue analgesia 12 months Time (in minutes) to 1st rescue analgesia (morphine) post operatively which will be defined to be the elapsed time between stoppage of fentanyl infusion and a patient FLACC score equal or more than 4.
Intra and postoperative heart rate. 12 months Intra and postoperative heart rate.
Trial Locations
- Locations (1)
Cairo University Hospitals
🇪🇬Cairo, Egypt