Clinical Trials Directory

Trials / Completed

CompletedNCT04444635

Serratus Anterior Plane Block in Pediatric Patients

Serratus Anterior Plane Block in Pediatric Patients Undergoing Thoracic Surgeries: A Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
70 (actual)
Sponsor
Cairo University · Academic / Other
Sex
All
Age
6 Months – 3 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURESerratus Anterior Plan Block+ Fentanyl infusionAfter induction of anesthesia, the patients will be put on the lateral position with the diseased side up. A linear ultrasound transducer will be placed in a sagittal plane over the mid-clavicular region of the thoracic cage. Then counting down ribs till the fifth rib will be identified in the mid-axillary line. The following muscles will be identified overlying the fifth rib: the latissimus dorsi (superficial and posterior),teres major (superior) and serratus muscles (deep and inferior). Under complete sterile conditions, the needle (25 G needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus anterior muscle. Then, 2 mg/kg of 0.25% bupivacaine will be injected with continuous ultrasound guidance. In addition to continuous fentanyl infusion
DRUGFentanylContinuous fentanyl infusion throughout the surgical procedure.

Timeline

Start date
2020-06-14
Primary completion
2021-06-10
Completion
2021-06-20
First posted
2020-06-23
Last updated
2021-06-25

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04444635. Inclusion in this directory is not an endorsement.