Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05526469 |
| Other study ID # |
FMASU R 110/ 2022 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 24, 2022 |
| Est. completion date |
March 31, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background and Objectives: Opioid based analgesia is the main used technique in pediatric
cardiac surgery which preclude fast-track recovery. Ultrasound guided regional fascial plane
blocks are used recently in many pediatric surgical procedure with excellent outcomes and
very low rate of complication. The investigators will compare ultrasound guided serratus
anterior plane block and erector spinae plane block in pediatric cardiac surgical procedure
through thoracotomy approach regarding effectiveness of postoperative analgesia, incidence of
complications and effect in ultrafast track recovery.
Methods: The investigators will enroll 64 pediatric patients aged from 6 months to 10 years
undergoing cardiac surgical procedure through thoracotomy approach either with or without
cardiopulmonary bypass in this prospective randomized study. After induction of general
anesthesia, the patients will be randomly assigned into 2 groups based regional fascial plane
block given (SAP group will receive ultrasound guided single shot serratus anterior plane
block and ESP group will receive ultrasound guided single shot erector spinae plane block).
The effectiveness of postoperative analgesia using FLACC pain score will be recorded as the
primary outcome while total consumption of analgesics, the time for rescue analgesia,
incidence of complications, and incidence of need for re-intubation will be recorded as the
secondary outcomes.
Description:
INTRODUCTION:
Pain control in pediatric cardiac surgery is an area of great interest with opioid based
analgesia is the mainstay used technique. Use of high doses of opioid usually preclude
early/ultrafast track recovery and extubation in operating room (OR). The benefits of
ultrafast track recovery include shorter intensive care unit (ICU) and hospital stay, lower
incidence of postoperative complications, reduce occurrence of ventilator induced
complications and infection, with better hemodynamics.
With the era of regional anesthetic techniques, there is an increasing need to use a novel
techniques of fascial plane block in pain control post cardiac surgery especially the use of
neuraxial blocks carry a great risk of spinal hematoma with use of high doses of heparin.
Ultrasound (U/S) guided serratus anterior plane block (SAPB) and erector spinae plane block
(ESPB) are used recently in many thoracic, breast and chest wall surgeries with high success
rate, low incidence of complications, and solid pain control with many studies demonstrated
superior efficacy in comparison to classic analgesic techniques. The use of SAPB and ESPB in
cardiac surgery in general and pediatric cardiac surgery are very limited. Both techniques
have been used in pediatric cardiac surgical procedures and provided a promising effect as a
simple, safe, and effective postoperative analgesic techniques.
The current study will compare the 2 novel fascial plane blocks -SAPB and ESPB- in pain
control and effectiveness for ultrafast track recovery in pediatric cardiac patients
undergoing cardiac surgical procedure through thoracotomy approach with or without
cardiopulmonary bypass (CBP). The primary outcome will be the effectiveness of postoperative
analgesia using FLACC (Face, Leg, Activity, Cry and Consolability) pain score and the
secondary outcome will be the total consumption of postoperative analgesics, the time for
first rescue analgesia, incidence of complications up to 24 hours, and incidence of need for
re-intubation in the first 6 hours.
AIM/ OBJECTIVES:
1. To compare the effectiveness of postoperative analgesia using FLACC pain score in
patients receiving SAP block versus ESP block in pediatric cardiac patients undergoing
cardiac surgical procedure through thoracotomy approach (primary outcome).
2. To determine the effect of SAP block on total consumption of postoperative analgesics,
the time for first rescue analgesia, incidence of complications up to 24 hours, and
incidence of need for re-intubation in the first 6 hours as compared to ESP block
(secondary outcome).
METHODOLOGY:
The study will be conducted at Ain Shams University Hospitals after ethical committee
approval and obtaining an informed written consent from patients' guardian.
- Type of Study; Randomized single blinded clinical trial.
- Study Setting; Pediatric cardiac surgery operating theatre in Ain shams university
hospital, Cairo, Egypt.
- Study Period; The study will be started immediately after ethical committee approval
starting August 2022 aiming to be completed within 6 months.
- Study Population
- Inclusion Criteria: The patients will be of ASA (American Society of
Anesthesiology) physical status II-III, aged between 6 months and 10 years old, of
both sexes, and undergoing cardiac surgical procedure through thoracotomy approach
either with or without cardiopulmonary bypass e.g. atrial septal defect (ASD)
closure, patent ductus arteriosus (PDA) ligation, and aortic coarctation repair.
- Exclusion Criteria: included patients weight less than 5 kg, coagulopathy, previous
cardiac surgery, emergency procedure, previous thoracotomy or sternotomy, surgery
through sternotomy incision, patients with complex surgical repair, and patients
need postoperative mechanical ventilation. Other exclusion criteria included
hypersensitivity to local anesthetics, infection at site of block injection, and
parent or guardian refusal.
- Sampling Method; Based on the block will be performed, patients will be randomly and
evenly assigned to one of two groups (32 patients each) using a computer-generated list:
Group SAP (serratus anterior plane) and group ESP (erector spinae plane).
Group SAP: patients will receive ultrasound guided single shot serratus anterior plane block
with 0.5 ml/kg bupivacaine 0.25%.
Group ESP: patients will receive ultrasound guided single shot erector spinae plane block
with 0.5 ml/kg bupivacaine 0.25%.
- Sample Size; This is a pilot clinical trial with no similar previous studies. The
primary outcome is to compare the mean score of the Pain scale between ESP and SAP at
different periods after extubation. Assuming large effect size of 0.8, A sample size of
at least 32 cases per group - totaling 64 cases in two groups - achieves a power of 80%
to detect a large effect size of 0.8 comparing the mean pain scores of the two groups
using two independent samples t-test with level of confidence of 0.05. Sample size is
inflated by 20% to compensate for dropouts.
- Ethical Considerations; After acquiring local medical ethics committee approval and
informed written consent from the parent or guardian, we will enroll 64 patients in this
study.
- Study Tools AND/ OR Study Procedures AND/OR Study Interventions; All patients will be
assessed and prepared preoperatively according to local hospital protocol. All patients
will be premedicated with IV Midazolam 0.1mg/kg 5 minutes before surgery (maximum of 2.5
mg). Routine monitoring with 5-lead ECG, non-invasive blood pressure and pulse oximetry
will be instituted, then anesthesia will be induced with IV propofol 2-3mg/kg, fentanyl
2mcg/kg, and cisatracurium 0.2 mg/kg, to facilitate endotracheal intubation. Sevoflurane
(1%-2%) in 30-50% oxygen in air mixture will be used for maintenance of anesthesia.
Cisatracurium infusion 2mcg/kg/min will be started after insertion of CVP line and will
be discontinued 30 min before skin closure. After intubation, all children will be
mechanically ventilated with volume control ventilation using 7-10 mL/kg tidal volume,
maintaining end-tidal carbon dioxide tension around 30-35 mmHg. Arterial line and
central venous catheter will be inserted to all patients. One of the 2 regional nerve
blocks (SAP, or ESP) will be performed with ultrasound guidance per group allocation.
The blocks will be performed with aseptic precautions using an 8 to13 megahertz (MHz)
linear probe (Philips®) in a sterile cover with sterile jelly and a 22-gauge 50 mm
echogenic block needle (SonoPlex® PAJUNK® , Germany).
Technique of SAP block; while the patient in the lateral position with the surgical/block
side upward, the ultrasound transducers will be placed in a sagittal plane over the
midclavicular area of the thoracic wall then the ribs will be counted till the 5th rib will
be identified in the midaxillary line. The following muscular layers will be recognized from
superficial to deep layers; latissimus dorsi then serratus anterior muscles. The needle will
be introduced from caudal to cranial direction with in-plane technique as related to the
ultrasound probe targeting the plane between the two muscles. Under real lime U/S guidance,
the local anesthetic solution will be injected after negative aspiration to blood or air with
making sure to visualize the plane of separation between the two muscles.
Technique of ESP block; while the patient in the lateral position with the surgical/block
side upward, the ultrasound transducers will be placed in a parasagittal plane 2-3 cm away
from the dorsal midline at the level of 5th thoracic vertebrae. Sliding the transducer
medially till identifying the transverse process which appear as flat acoustic shadow (the
ribs appears as rounded acoustic shadows more laterally) with an interceding hyperechoic
pleural line. The following muscular layers will be recognized from superficial to deep
layers; trapezius, rhomboid, then erector spinae muscles. The needle will be introduced
either cranio-caudal or caudo-cranial direction with in-plane technique as related to the
ultrasound probe targeting the plane between the erector spinae muscle and transverse process
of T5. Under real lime U/S guidance, the local anesthetic solution will be injected after
negative aspiration to blood or air with making sure to visualize the plane of separation
under the erector spinae muscle.
Any complications related to the block given will be recorded including hematoma,
intravascular injection, and allergic reactions. The duration of performing the block will be
also recorded. Intraoperative hemodynamic parameters will be recorded including heart rate
(HR), systolic blood pressure (SBP), mean arterial pressure (MAP), respiratory rate (RR), and
peripheral oxygen saturation (SPO2) at the following intervals; baseline before induction of
anesthesia, just before skin incision, after skin incision, 15 min after skin incision, at
the end of surgery, and after extubation. Total doses of intraoperative opioids including
fentanyl and or morphine will be calculated and recorded.
After skin closure inhalational anesthesia will be discontinued and reversal of muscle
relaxant after returning of spontaneous breathing will be acquired. Tracheal extubation will
be performed after ensuring adequate tidal volume, respiratory rate along with hemodynamic
stability, normothermia, normal blood gases parameters, and the patient is fully conscious.
After extubation and ensuring hemodynamic stability, the patient will be transferred to ICU
fully monitored and connected to oxygen simple face mask 6 L/min.
Pain assessment will be done using the FLACC pain scale score at the following intervals;
immediate post-extubation, every 1 hour for the 1st 6 hours postoperatively then every 2
hours for the next 6 hours then every 4 hours till 24 hours postoperatively. Rescue analgesic
will be used if FLACC pain scale score is 4 or more according to hospital protocol. Time of
the 1st postoperative rescue analgesia will be recorded, also total doses of analgesic given
will be recorded.
Postoperative hemodynamic parameters will be recorded including HR, SBP, MAP, RR, and SPO2 at
the following intervals; hourly for the 1st 6 hours postoperatively then every 2 hours for
the next 6 hours.
Need for tracheal re-intubation within 6 hours from recovery will be considered as failed
ultrafast trach recovery and will be recorded. Length of stay in ICU will be recorded.
The data during surgery and after surgery will be collected by the resident anesthetist not
involved in the study.
- Statistical Analysis; Numerical data are presented as the mean (standard deviation) or
median (range) while categorical data are presented as the number of cases (percentage).
Between-group comparisons of numerical variables will be performed by the independent
sample T-test, or Mann-Whitney test as appropriate, while those of categorical variables
will be performed by the Chi-square test. For all tests, a P (probability) value < 0.05
will be considered statistically significant.
- Statistical Package; The data collected will be analyzed with statistical program SPSS
(version 22.0 Chicago, Illinois, USA).
