Comparison Between Serratus Anterior Plane Block and Erector Spinae Plane Block in Coarctectomy
- Conditions
- Aortic Coarctation
- Interventions
- Procedure: block
- Registration Number
- NCT06567275
- Lead Sponsor
- Cairo University
- Brief Summary
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, will lead to various systemic complications; pulmonary (atelectasis, pneumonia, and stasis of bronchial secretions), cardiovascular (increased oxygen consumption and tachycardia), musculoskeletal (muscle weakness), increased neurohormonal response and prolonged hospital stay. So adequate and sufficient post-operative analgesia for pediatric patients is mandatory.
The use of highly potent opioids for pediatric cardiothoracic anesthesia has gained widespread popularity during the last 20 years. In addition to the important advantage of hemodynamic stability, the large-dose opioid-based anesthetic techniques also blunt the stress response, However, large doses can cause oversedation, respiratory depression, and prolonged mechanical ventilation after surgery.
serratus anterior plane block guided by ultrasound was developed by Blanco et al, it is a novel technique in the management of pain following thoracic procedures.
Local anesthetic inserted into these planes will spread throughout the lateral chest wall, resulting in paresthesia of the T2 through T9 dermatomes of the anterolateral thorax. It became popular because it is much safer and easily administered than other alternative regional techniques such as thoracic paravertebral and thoracic epidural blocks.
The Erector Spinae Plane Block (ESPB) is also one of the recently known pain-controlling techniques used in pediatric cardiothoracic surgeries. It became popular because it is much safer and easily administered than other alternative regional techniques such as thoracic paravertebral and thoracic epidural blocks. Chin et al. documented the cadaveric spread of local anesthetic and noted that, radiologically, the local anesthetic spread extended 3 or 4 levels cranially and caudally from the site of injection.
These two blocks have been compared in a study by wang HJ et al in patients undergoing radical mastectomy.
To our knowledge, the comparison of serratus Plane Block versus erector spinae plane block in aortic coarctectomy operations in pediatric patients has not been investigated yet. This has encouraged the performance of the present study.
- Detailed Description
comparison between the perioperative analgesic efficacy and any side effects of U/S guided serratus anterior plane block versus the erector spinae plane block in pediatric patients undergoing aortic coarctectomy.
Objectives:
* To calculate the total intraoperative fentanyl (boluses) consumption.
* To assess the need and dose for intra-operative direct vasodilator (Na nitroprusside) after aortic clamping.
* Recording intra-operative and post-operative vital signs including heart rate (HR) and Systolic arterial blood pressure (SBP).
* To calculate total Morphine consumption during the 1st 24 hours postoperatively.
* To evaluate the Time (in minutes) to 1st rescue analgesia (Morphine).
* To assess the degree of pain every 2 hours for the first 24 hours postoperatively by using the pain FLACC score.
* ICU stay time.
Hypothesis We hypothesize that U/S guided serratus anterior plane block will provide as good analgesic effect as ESPB in pediatric patients undergoing aortic coarctectomy.
Ethical Considerations After the approval of the institutional Research Ethics Committee, informed consent will be obtained from the patient's parents or legal guardians prior to the commencement of the study.
Methodology
I.Study design
* Our study will be designed to estimate and compare the analgesic effect of single shot serratus anterior plane block in pediatric patients undergoing aortic coarctectomy via thoracotomy incision versus erector spinae plane block.
* Patients will be randomly allocated to 2 equal groups 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. An anesthesia resident not involved in patient management will be responsible for opening the envelope. The anesthesia resident will give the instructions contained within each envelope to the anesthesiologist. Data collection will be done by a blinded anesthesiologist.
II.Study setting and location
The study will be conducted in the pediatric cardiothoracic operation theatre (Pediatric Specialized Hospital, Cairo University) III. Study population IV. The study will be conducted on 28 pediatric patients aged 3 months-2 years, RACHS-1 score 3 undergoing aortic coarctectomy (with thoracotomy incision). Twenty patients will be randomly assigned to one of 2 groups (n=14 each) V. Group (A). Ultrasound-guided erector spinae plane block will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%).
VI. Group(B): Ultrasound-guided serratus anterior plane block will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%).
VII. VIII. Eligibility Criteria
1. Inclusion criteria
* Age: 3 months-2 years.
* RACHS-1 score 3.
* Patients undergoing aortic coarctectomy operation with Lateral thoracotomy incision.
2. Exclusion criteria
* Patients whose parents or legal guardians refuse to participate.
* Preoperative mechanical ventilation.
* Preoperative inotropic drug infusion.
* Perioperative cardiopulmonary arrested patients.
* Patients undergoing aortic coarctectomy operation with midline sternotomy incision.
* History of mental retardation or delayed development that may interfere with pain intensity assessment.
* Known or suspected coagulopathy. (PT \< 75% of control)
* Any congenital anomalies or any infection at the site of injection.
* Known or suspected allergy to any of the studied drugs.
* liver enzymes elevated more than the normal values.
* Renal function impairment (Creatinine value more than 1.2mg/dl or BUN more than 20mg/dl).
* Heart failure patients
* Redo patients and previous catheter dilatations
IX.Study Procedures
-Preoperative: -
All patients will attend the pre-anesthesia room with their parents 1 hour before the procedure after taking approval from the research ethical committee and informed consent.
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, and blood grouping, fasting hours more than 6 hours for formula milk, 4 hours for breast milk, and 2 hours for clear fluids will be checked(9).
-Intraoperative: -
ECG, pulse oximetry, and non-invasive blood pressure will be applied to all patients.
All patients will be premedicated with intramuscular midazolam 0.08mg/Kg and atropine 0.01 mg/Kg 20 minutes before induction of anesthesia using GE P 650 monitor.
Anesthesia will be induced in all patients by sevoflurane 5% in 100% O2 followed by Placement of peripheral I.V cannula and IV administration of fentanyl (1-2µg/kg). Oral endotracheal intubation will be facilitated by IV atracurium 0.5 mg/kg and then a 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 7-10 ml/kg and respiratory rate will be 15 to 35 cycle/minute according to the age. We aim to keep end-tidal CO2 between 30-40 mmHg After maintenance of anesthesia using Sevoflurane 2%, a nasopharyngeal temperature probe will be placed. A central venous catheter and a right upper limb arterial cannula will be introduced and connected to the invasive blood pressure dome.
After the change of the patient's position from supine to lateral position, the patient will be allocated to one of the following groups:
1. Group A: Patients in Group A will receive ultrasound-guided unilateral erector spinae plane block by injecting 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) as follows (6):
* 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 as superior to the hyperechoic transverse process.
* Using an in-plane approach a 25 G needle will be inserted in the cephalo-caudal direction until the tip is deep to the erector spinae muscle.
* Correct needle tip location will be confirmed by injecting 0.5 ml of normal saline and visualizing the linear LA spread (i.e., hydro dissection) in the fascial plane between the erector spinae muscle and the transverse process.
* Negative aspiration before injection will be performed to avoid inadvertent intravenous injection of local anesthetic.
* 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) will be injected and visualizing the linear LA spread (i.e., hydro dissection) in the fascial plane between the erector spinae muscle and the transverse process.
2. Group (B): ultrasound-guided serratus anterior plane block will be done in this group of patients by injecting 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%). This will be performed on the same side of the planned thoracotomy as follows:
* The ultrasound machine used will be S-Nerve Ultrasound System P07576, USA with SL Ax/6-13MHz linear high-frequency transducer Under strict aseptic precautions, the ultrasound transducer will be placed over the med-clavicular region of the thoracic cage in a sagittal plane. We will count the ribs inferiorly and laterally until we identified the fifth rib in the midaxillary line. The latissimus dorsi (superficial and posterior), teres major(superior), and serratus muscles (deep and inferior) will be then easily identifiable by ultrasound overlying the fifth rib. The needle depth required to reach the identified region is constant between one and two.
* Under aseptic precautions, the needle (22-gauge, 2.5-5 cm short beveled needle or blunt-tipped hypodermic needle) is inserted and advanced perpendicular to the skin in all planes to contact the rib. The depth of the rib from the skin varies depending upon the build of the individual. After hitting the rib, the needle tip is withdrawn 1--2 mm. At this point, the needle tip lies between the SAM and the rib. After negative aspiration for blood or air local anesthetic will be injected at 0.4ml/kg according to a safe dose of 0.25 % bupivacaine and 1% lidocaine.
* Correct needle tip location will be confirmed by injecting 0.5 mL of normal saline and visualizing the linear LA spread (i.e., hydro dissection) in the fascial plane between the serratus anterior muscle and the rib.
* 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., hydro dissection) in the fascial plane between serratus anterior muscle and the rib(5).
20 min after the block, skin incision will be started and rescue analgesia by a bolus of (Fentanyl 1mcg/kg) will be given to the patients in either group if either systolic blood pressure or heart rate 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.
The block will be considered a failed block if the patient will require more than two boluses of fentanyl during the first hour of the skin incision and this case will be excluded from the study.
Ten minutes before aortic cross-clamping, heparin in a dose of 1-2mg/kg will be given iv targeting an activated clotting time greater than 250 seconds.
After aortic cross-clamping, Sodium nitroprusside infusion will be started at a dose of 0.5mcg/kg/min and increased according to the response, if the blood pressure is still elevated despite one bolus of fentanyl.
Sodium nitroprusside infusion will be stopped one minute before aortic de-clamping. Post-de-clamping hypotension will be managed by 1-2 ml of calcium gluconate and 10 ml/kg of isotonic saline. If hypotension persisted, a bolus of 5-10 mcg intravenous norepinephrine will be given. If the patient is still hypotensive, an infusion of 0.25 mcg/kg/min of norepinephrine will be started till stabilization of blood pressure.
Atracurium infusion will be stopped 15 minutes before skin closure. Finally, Inhalational anesthesia will be discontinued at the end of the operation. And residual neuromuscular block will be antagonized with atropine 0.01 mg/kg and neostigmine 0.05 mg/kg before extubation on the table (if fulfilled extubation criteria).
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 intraoperative fentanyl consumption will be calculated. Vital signs including HR and SBP from the radial arterial line will be recorded at the following intervals; (T1; baseline reading 5 min after intubation, T2; before skin incision 15 minutes after the block, T3; after skin incision, T4; after rib retraction, T5; after aortic clamping, T6; after aortic declamping, T7; immediately after skin closure andT7; 15 min after extubation).
The need and dose for direct vasodilator (sodium nitroprusside) after aortic clamping.
In the Pediatric ICU:
Time (in minutes) to 1st rescue analgesia (Morphine). Total consumption of morphine during the 1st 24 hours post-operatively will be calculated.
Vital signs including HR and SBP every 2 hours or the first 6 hours postoperatively.
ICU stay time. Pain score assessment every 2 hours for the first 24 hours post-operatively by FLACC score If the FLACC score equals or more than 4, morphine I.V as a rescue analgesia in a dose of 0.02 mg/kg will be given to be repeated every 15-20 minutes till the pain score reaches \< 4, with a maximum dose of 0.2 mg/kg every 6 hours (7).
.
X.Study outcomes
Primary outcome
Total intraoperative fentanyl consumption by mcg/kg. Secondary outcome(s)
* Intra and postoperative and vital signs including HR and SBP.
* The need and dose for direct vasodilator (sodium nitroprusside) after aortic cross-clamping.
* Time (in minutes) to 1st rescue analgesia (morphine) If FLACC score equals or more than 4, postoperatively (definition: it is the time elapsed between the block and the first dose of morphine given postoperatively) .
* Total consumption of morphine during the 1st 24 hours postoperatively will be calculated.
* Pain assessment every 2 hours for the first 24 hours postoperatively by FLACC score.
* ICU stay time.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 28
- Age: 3 months-2 years.
- RACHS-1 score 3.
- Patients undergoing aortic coarctectomy operation with Lateral thoracotomy incision.
- Patients whose parents or legal guardians refuse to participate.
- Preoperative mechanical ventilation.
- Preoperative inotropic drug infusion.
- Perioperative cardiopulmonary arrested patients.
- Patients undergoing aortic coarctectomy operation with midline sternotomy incision.
- History of mental retardation or delayed development that may interfere with pain intensity assessment.
- Known or suspected coagulopathy. (PT < 75% of control)
- Any congenital anomalies or any infection at the site of injection.
- Known or suspected allergy to any of the studied drugs.
- liver enzymes elevated more than the normal values.
- Renal function impairment (Creatinine value more than 1.2mg/dl or BUN more than 20mg/dl).
- Heart failure patients
- Redo patients and previous catheter dilatations
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description erector spinae plane block block Ultrasound-guided erector spinae plane block will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%). serratus anterior plane block block Ultrasound-guided serratus anterior plane block will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%).
- Primary Outcome Measures
Name Time Method Total intraoperative fentanyl consumption by mcg/kg. Pain score assessment every 2 hours for the first 24 hours post-operatively by FLACC score calculating the total dose of fentanyl used intraoperatively
- Secondary Outcome Measures
Name Time Method Time (in minutes) to 1st rescue analgesia (morphine) 1st 24 hours postoperatively estimating the time of the need for 1st dose of morphine
Trial Locations
- Locations (1)
Abu Elreish Hospital
🇪🇬Cairo, Egypt