Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567275
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Comparison Between Serratus Anterior Plane Block and Erector Spinae Plane Block in Coarctectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
ANALGESIC EFFECT OF ULTRASOUND GUIDED ERECTOR SPINAE PLANE BLOCK VERSUS SERRATUS ANTERIOR PLANE BLOCK IN PEDIATRIC PATIENTS UNDERGOING AORTIC COARCTECTOMY A RANDOMIZED CONTROLLED STUDY
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
comparison between the perioperative analgesic efficacy and any side effects of US guided serratus anterior plane block versus the erector spinae plane block in pediatric patients undergoing aortic coarctectomy
Detailed Description:
comparison between the perioperative analgesic efficacy and any side effects of US 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 US 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 patients parents or legal guardians prior to the commencement of the study
Methodology
IStudy 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
IIStudy 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 n14 each V Group A Ultrasound-guided erector spinae plane block will be done by injecting 04 mlkg 11 solution of bupivacaine 025 and lidocaine 1
VI GroupB Ultrasound-guided serratus anterior plane block will be done by injecting 04 mlkg 11 solution of bupivacaine 025 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 12mgdl or BUN more than 20mgdl
Heart failure patients
Redo patients and previous catheter dilatations
IXStudy 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 checked9
-Intraoperative -
ECG pulse oximetry and non-invasive blood pressure will be applied to all patients
All patients will be premedicated with intramuscular midazolam 008mgKg and atropine 001 mgKg 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 IV cannula and IV administration of fentanyl 1-2µgkg Oral endotracheal intubation will be facilitated by IV atracurium 05 mgkg 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 05 mg kg hr
All patients will be mechanically ventilated using pressure-controlled mode with FiO2 50 PEEP 5 cmH2O I E ratio of 12 peak inspiratory pressure PIP will be set to deliver a tidal volume of 7-10 mlkg and respiratory rate will be 15 to 35 cycleminute 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 patients 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 04mlkg 11 solution of bupivacaine 025 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 05 ml of normal saline and visualizing the linear LA spread ie 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
04mlkg 11 solution of bupivacaine 025 and lidocaine 1 will be injected and visualizing the linear LA spread ie 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 04mlkg 11 solution of bupivacaine 025 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 Ax6-13MHz 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 majorsuperior 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 25-5 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 04mlkg according to a safe dose of 025 bupivacaine and 1 lidocaine
Correct needle tip location will be confirmed by injecting 05 mL of normal saline and visualizing the linear LA spread ie hydro dissection in the fascial plane between the serratus anterior muscle and the rib
04 mlkg 11 solution of bupivacaine 025 and lidocaine 1 will be injected and visualizing the linear LA spread ie hydro dissection in the fascial plane between serratus anterior muscle and the rib5
20 min after the block skin incision will be started and rescue analgesia by a bolus of Fentanyl 1mcgkg 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 1-2mgkg 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 05mcgkgmin 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 mlkg 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 025 mcgkgmin 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 001 mgkg and neostigmine 005 mgkg 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 IV 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 IV as a rescue analgesia in a dose of 002 mgkg will be given to be repeated every 15-20 minutes till the pain score reaches 4 with a maximum dose of 02 mgkg every 6 hours 7
XStudy outcomes
Primary outcome
Total intraoperative fentanyl consumption by mcgkg Secondary outcomes
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
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 US 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 patients parents or legal guardians prior to the commencement of the study
Methodology
IStudy 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
IIStudy 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 n14 each V Group A Ultrasound-guided erector spinae plane block will be done by injecting 04 mlkg 11 solution of bupivacaine 025 and lidocaine 1
VI GroupB Ultrasound-guided serratus anterior plane block will be done by injecting 04 mlkg 11 solution of bupivacaine 025 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 12mgdl or BUN more than 20mgdl
Heart failure patients
Redo patients and previous catheter dilatations
IXStudy 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 checked9
-Intraoperative -
ECG pulse oximetry and non-invasive blood pressure will be applied to all patients
All patients will be premedicated with intramuscular midazolam 008mgKg and atropine 001 mgKg 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 IV cannula and IV administration of fentanyl 1-2µgkg Oral endotracheal intubation will be facilitated by IV atracurium 05 mgkg 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 05 mg kg hr
All patients will be mechanically ventilated using pressure-controlled mode with FiO2 50 PEEP 5 cmH2O I E ratio of 12 peak inspiratory pressure PIP will be set to deliver a tidal volume of 7-10 mlkg and respiratory rate will be 15 to 35 cycleminute 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 patients 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 04mlkg 11 solution of bupivacaine 025 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 05 ml of normal saline and visualizing the linear LA spread ie 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
04mlkg 11 solution of bupivacaine 025 and lidocaine 1 will be injected and visualizing the linear LA spread ie 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 04mlkg 11 solution of bupivacaine 025 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 Ax6-13MHz 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 majorsuperior 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 25-5 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 04mlkg according to a safe dose of 025 bupivacaine and 1 lidocaine
Correct needle tip location will be confirmed by injecting 05 mL of normal saline and visualizing the linear LA spread ie hydro dissection in the fascial plane between the serratus anterior muscle and the rib
04 mlkg 11 solution of bupivacaine 025 and lidocaine 1 will be injected and visualizing the linear LA spread ie hydro dissection in the fascial plane between serratus anterior muscle and the rib5
20 min after the block skin incision will be started and rescue analgesia by a bolus of Fentanyl 1mcgkg 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 1-2mgkg 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 05mcgkgmin 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 mlkg 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 025 mcgkgmin 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 001 mgkg and neostigmine 005 mgkg 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 IV 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 IV as a rescue analgesia in a dose of 002 mgkg will be given to be repeated every 15-20 minutes till the pain score reaches 4 with a maximum dose of 02 mgkg every 6 hours 7
XStudy outcomes
Primary outcome
Total intraoperative fentanyl consumption by mcgkg Secondary outcomes
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None