Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05559684 |
| Other study ID # |
md-61-2022 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2022 |
| Est. completion date |
September 14, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Corrective cardiac surgeries include a bundle of major surgeries that take place in pediatric
patients and require imperative perioperative pain control; hence, the art of healing starts
from trying to diminish or abolish pain.
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 over sedation, respiratory depression and prolonged mechanical
ventilation after surgery .
There are many ways to limit pain in such population with the topper potent opioids in the
last several years. But new regional pain management modalities started to arise because of
their known effect to diminish neuroendocrine stress response, provide excellent
postoperative analgesia, and facilitate early postoperative extubation .
Of the new evolving methods, the bilateral Transversus Thoracic Muscle Plane Block (TTPB)
provides analgesia to the anterior chest wall and proved to be efficient in pediatric
patients undergoing cardiac surgery using a median sternotomy approach .
The bilateral Erector Spinae Plane Block (ESPB) is also one of the recently known pain
controlling techniques used in pediatric cardiac surgeries. It became popular because it is
much safer and easily administered than other alternative regional techniques as thoracic
paravertebral and thoracic epidural block .
Description:
I. Study design and randomization
Our study will be designed to estimate the analgesic effect of single shot bilatral
transversus thoracic muscle plane block compared to that of erector spinae plane block in
pediatric patients undergoing corrective cardiac surgeries including atrial septal defect
(ASD) repair, ventricular septal defect (VSD) repair, atrioventricular (AV) canal repair,
Glenn procedure, Fontan procedure and subaortic membrane resection. Our primary outcome will
be the total dose of intra-operative fentanyl boluses.
Randomization will be achieved by using an online random number generator. Patient codes will
be placed into sequentially numbered sealed opaque envelopes by a research assistant who is
not involved in the study. A medical doctor not involved in patient management will be
responsible for opening the envelope and give the instructions contained within each envelope
to the anesthesiologist who is expert in doing the ESPB in patients included within the block
group. This expert anaesthesiologist will not be involved in collecting data but another
anaesthesist blinded to the type of block will be responsible for patient management and
collecting the intra-operative and postoperative data.
II. Study setting and location
The study will be conducted in the pediatric cardiothoracic operation theatre in Abu El Reesh
Pediatric Hospital - Cairo University.
III. Study population
The study will be conducted on pediatric patients aged 2 months - 4 years, ASA II and III
undergoing corrective cardiac surgeries (with midline sternotomy incision). The patients will
be randomly assigned to one of 3 groups Group (A): (Control group): This group will receive
fentanyl infusion at a dose of (0.5 μg/kg/h) all through the whole operation .
Group (B): This group will receive fentanyl infusion at a dose of (0.5 μg/kg/h) all through
the whole operation plus Ultrasound guided bilateral ESPB which will be done by injecting 0.4
ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side .
Group (C): This group will receive fentanyl infusion at a dose of (0.5 μg/kg/h) all through
the whole operation plus ultrasound guided bilateral TTPB which will be done by injecting 0.4
ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side .
IV. Study Procedures
-Preoperative:-
All patients will attend at the pre- anesthesia room with their parents 1 hour before the
procedure after taking approval of research ethical committee and informed consent.
Detailed history from the parents will be taken followed by a full and detailed clinical
examination of the child then all investigations including CBC, coagulation profile, liver
enzymes, kidney function tests, CXR, echocardiography/cardiac catheterization and blood
grouping will be checked.
-Intraoperative:-
Non-invasive blood pressure, pulse oximetry and ECG will be applied to all patients. All
patients will be premedicated by intramuscular midazolam 2mg/Kg and atropine 0.2 mg/Kg 20
minutes before induction of anesthesia.
Anesthesia will be induced in all patients by sevoflurane5% in 50% O2 followed by placement
of peripheral I.V cannula and IV administration of fentanyl (0.5 µg/kg). Oral endotracheal
intubation will be facilitated by IV atracurium 0.5 mg/kg and then capnogram will be
connected to monitor End-tidal CO2 and muscle relaxation will be maintained by atracurium
infusion in a dose of 0.5 mg/ kg/ hr.
All patients will be mechanically ventilated using pressure controlled mode with FiO2 50%,
PEEP 5 cmH2O, I : E ratio of 1:2, peak inspiratory pressure (PIP) will be set to deliver a
tidal volume of 6-8 ml/kg and respiratory rate will be 15 to 35 cycle / minute according to
the age. Our aim is to keep end tidal CO2 between 30-40 mmHg. Isoflurane will be used for
maintenance of anaesthesia.
After insertion of a central venous catheter and an arterial cannula, nasopharyngeal
temperature probe will be placed.
Patients in Group A will receive fentanyl infusion at a dose of (0.5 μg/kg/h) all through the
whole operation.
Patients in Group B will receive fentanyl infusion at a dose of (0.5 μg/kg/h) in addition to
ultrasound guided bilateral erector spinae plane block by injecting 0.4ml/kg (1:1 solution of
bupivacaine 0.25% and lidocaine 1%) at each side as follows :
Under strict aseptic precautions, The T3 spinous process will be located by palpating and
counting down from the C7 spinous process.
A high-frequency 12 MHz linear ultrasound transducer will be placed in a longitudinal
orientation 3 cm lateral to the T3 spinous process corresponding to the T2 transverse
process.
Three muscles; trapezius (uppermost), rhomboids major (middle), and erector spinae
(lowermost) will be identified superior to the hyperechoic transverse process.
Using in-plane approach a 25 G needle will be inserted in caudal-cephalad direction, until
the tip is deep to erector spinae muscle.
Correct needle tip location will be confirmed by injecting 3 mL of normal saline and
visualizing the linear LA spread (i.e., hydrodissection) in the fascial plane between the
erector spinae muscle and the transverse process.
Now, 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) will be injected and
visualizing the linear LA spread (i.e., hydrodissection) in the fascial plane between the
erector spinae muscle andthe transverse process.
Patients in Group C will receive fentanyl infusion at a dose of (0.5 μg/kg/h) plus ultrasound
guided bilateral transversus thoracic muscle plane block by injecting 0.4ml/kg (1:1 solution
of bupivacaine 0.25% and lidocaine 1%) at each side as follows :
Under strict aseptic precautions, the T4-T5 intercostal space is identified under US using
the US probe in the longitudinal plane 1 cm lateral to the sternal border. A high-frequency
linear transducer is used.
Next, a parasternal sagittal view of the intercostal muscle and the transverses thoracis
muscle between the 4th and 5th rib is visualized above the pleura and a 22G, 5-10 cm needle
is inserted in-plane (according to patient's body habitus and relevant anatomy) to the
transducer with bevel up until the tip of the needle is located in the transverses thoracis
muscles.
After excluding intravascular and intrapleural placement, local anesthetic is adminstred
bilaterally by injecting 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at
each side.
After 15 min, skin incision will be started and rescue analgesia by a bolus of (Fentanyl
1mcg/kg) will be given to the patients in each group. If either mean blood pressure (MBP) or
heart rate (HR) increased more than 20% of the baseline readings (as recorded 5 minutes after
intubation) provided that there is no other cause of these hemodynamic changes such as
inadequate anesthesia and surgical complications.
The block will be considered a failed block if the patient will require more than two boluses
of fentanyl during the first 30 minutes of the skin incision and this case will be excluded
from the study.
-Postoperative:- All patients will be discharged to the pediatric ICU where they will receive
paracetamol in a dose of 15 mg/ kg I.V. every 6 hours as a standard protocol in our unit.
Measurement tools:
Intra-operative:
- The total dose of fentanyl will be calculated.
- Vital signs including HR and MBP will be recorded at the following intervals; (T1:
baseline reading 5 min after intubation, T2: after skin incision, T3: after sternotomy,
T4: after aortic cannulation, T5: after weaning from bypass and T6: after skin closure).
In the Pediatric ICU:
- Time (in minutes) to 1st rescue analgesia post operatively (Fentanyl) which will be
defined to be the elapsed time between giving the block and a patient FLACC score (Table
1) equal or more than 4.
- Total consumption of Fentanyl during the 1st 12 hours post operatively will be
calculated.
- Haemodynamics including HR and MBP immediately after admission to ICU then at 60 min, 2
hours, 4hours, 8 hours and 12 hours
- The incidence of complications like postoperative vomiting, hematoma formation, itching,
local anesthetic toxicity.
- Pain score assessment immediately after admission to ICU then at 60 min, 2 hours,
4hours, 8hours and 12 hours postoperatively by FLACC score
- How to assess pain using FLACC score:
1. Face
● Score 0 point if patient has a relaxed face, eye contact and interest in
surroundings
- Score 1 point if patient has a worried look to face, with eyebrows
lowered, eyes partially closed, cheeks raised, mouth pursed
- Score 2 points if patient has deep furrows in the forehead, with closed
eyes, open mouth and deep lines around nose/lips
2. Legs
● Score 0 points if patient has usual tone and motion to limbs (legs and arms)
- Score 1 point if patient has increase tone, rigidity, tense, intermittent
flexion/extension of limbs
- Score 2 points if patient has hyper tonicity, legs pulled tight,
exaggerated flexion/extension of limbs, tremors.
3. Activity
● Score 0 points if patient moves easily and freely, normal
activity/restrictions
● Score 1 point if patient shifts positions, hesitant to move, guarding, tense
torso, pressure on body part
● Score 2 points if patient is in fixed position, rocking, side-to-side head
movement, rubbing body part.
4. Cry
● Score 0 points if patient has no cry/moan awake or asleep
● Score 1 point if patient has occasional moans, cries, whimpers, sighs
● Score 2 points if patient has frequent/continuous moans, cries, grunts.
5. Consolability ● Score 0 points if patient is calm and does not require
consoling ● Score 1 point if patient responds to comfort by touch or talk in
½- 1 minute
- Score 2 points if patient requires constant comforting or unable to
console. Pain was assessed by the pediatric observational 10-point scale
"Face, Leg, Activity, Cry, Consolability (FLACC) pain score.and if the
patient FLACC score equal or more than 4, he will receive morphine i.v
0.1mg /kg .
