Ignite Creation Date:
2024-07-17 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478654
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-23
Brief Title:
Modified Pectoral Nerve Block Vs Thoracic Erector Spinae Plane Block for Analgesia for Aesthetic Breast Surgeries
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Ultrasound Guided Bilateral Modified Pectoral Nerve PECS II Block Vs Bilateral Thoracic Erector Spinae Plane ESP Block for Postoperative Analgesia for Aesthetic Breast Surgeries
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to evaluate The Effectiveness of Ultrasound Guided Modified Pectoral Nerve Block PECS II versus Thoracic Erector Spinae Plane Block ESPB for postoperative Analgesia in cases of aesthetic breast surgeries
Detailed Description:
Preoperative settings
All the patients will be fasting for solid food for at least 6 hours and for clear fluids for 4 hours before surgery and will be instructed about Numeric Rating Scale NRS and its interpretation
Intravenous access will be inserted premedication with midazolam 3 mg will be done On arrival to operating room routine monitoring including electrocardiography ECG non-invasive arterial blood pressureNIBP and pulse oximetry will be used The mean arterial blood pressure MAPand heart rate HR will be recorded before induction of general anaesthesia baseline
Intraoperative postoperative settings
A prophylactic antibiotic will be given after skin sensetivity test then General Intravenous anaesthesia induction will be done Patient inductions by Propofol 2 mgkg Atracurium 05 mgkg and Fentanyl 1 µgkg Endotracheal intubation will be settled then Patients will be mechanically ventilated and ventilator parameters will be set to keep end tidal CO2 between 30-35 mmHg guided by Capnogram Anaesthesia will be maintained with Isoflurane 15 to 2 vol Patient will be given 50 oxygenair mixture and Incremental doses of fentanyl 05µgkg will be given every 1 hour The depth of anaesthesia will be adjusted to keep changes of hemodynamics MAP and HR within the range of 20 of the baseline
Under complete aseptic conditions The blocks will be performed by a consultant anesthesiologist with a 5-year of experience in regional nerve blocks
The blocks will be performed with a 20gauge echogenic needle Pajunk 120mm Germany
The patients will be randomly divided into two groupsthen the desired block will be done
Surgical procedure will be started after performing the desired block
At the end of surgery Patients will be extubated after reversal of muscle relaxant by neostigmine 005 mgkg with atropine 002 mgkg Patients will be transported to Post Anaesthesia care unit PACU HR systolic diastolic and mean pressures will be observed
All the patients will be fasting for solid food for at least 6 hours and for clear fluids for 4 hours before surgery and will be instructed about Numeric Rating Scale NRS and its interpretation
Intravenous access will be inserted premedication with midazolam 3 mg will be done On arrival to operating room routine monitoring including electrocardiography ECG non-invasive arterial blood pressureNIBP and pulse oximetry will be used The mean arterial blood pressure MAPand heart rate HR will be recorded before induction of general anaesthesia baseline
Intraoperative postoperative settings
A prophylactic antibiotic will be given after skin sensetivity test then General Intravenous anaesthesia induction will be done Patient inductions by Propofol 2 mgkg Atracurium 05 mgkg and Fentanyl 1 µgkg Endotracheal intubation will be settled then Patients will be mechanically ventilated and ventilator parameters will be set to keep end tidal CO2 between 30-35 mmHg guided by Capnogram Anaesthesia will be maintained with Isoflurane 15 to 2 vol Patient will be given 50 oxygenair mixture and Incremental doses of fentanyl 05µgkg will be given every 1 hour The depth of anaesthesia will be adjusted to keep changes of hemodynamics MAP and HR within the range of 20 of the baseline
Under complete aseptic conditions The blocks will be performed by a consultant anesthesiologist with a 5-year of experience in regional nerve blocks
The blocks will be performed with a 20gauge echogenic needle Pajunk 120mm Germany
The patients will be randomly divided into two groupsthen the desired block will be done
Surgical procedure will be started after performing the desired block
At the end of surgery Patients will be extubated after reversal of muscle relaxant by neostigmine 005 mgkg with atropine 002 mgkg Patients will be transported to Post Anaesthesia care unit PACU HR systolic diastolic and mean pressures will be observed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None