Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-01 @ 11:33 PM
Study NCT ID:
NCT07149168
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2025-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Pericapsular Nerve Block Using Dexmedetomidine and Bupivacaine in Improving the Outcome of Patients Undergoing Hip Surgery Under Spinal Anesthesia
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Role of Pericapsular Nerve Block Using Dexmedetomidine and Bupivacaine in Improving the Outcome of Patients Undergoing Hip Surgery Under Spinal Anesthesia
Status:
COMPLETED
Status Verified Date:
2024-12
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 investigators will compare the effectiveness and safety of the pericapsular nerve block (PENG) using dexmedetomidine and bupivacaine before giving spinal anesthesia in improving the quality and success rate of spinal anesthesia for Fracture Neck Femur surgery versus spinal anesthesia alone.
Detailed Description:
\- Pre-operative settings: Patients scheduled for Fracture Neck Femur surgery under spinal anesthesia will be thoroughly evaluated pre-operatively. A detailed medical history will be obtained, and all patients will undergo a comprehensive physical examination, with particular attention to neurological assessment to exclude any pre-existing conditions that might influence the study outcomes. Additionally, pre-operative laboratory tests, including complete blood count, and coagulation profile, will be reviewed to ensure patient eligibility and safety.
2- Intraoperative Settings: Monitoring: Upon entering the operating room, standard monitoring will be applied to all patients, including pulse oximetry (SpO2), non-invasive blood pressure (NIBP), heart rate (HR), and electrocardiogram (ECG). Baseline measurements will be recorded before any anesthetic intervention.
Intravenous Access: An intravenous (IV) cannula will be inserted, and IV fluids will be initiated.
Group A (Control Group):
For spinal anesthesia in fracture neck femur surgery, a typical dose of 0.5% hyperbaric bupivacaine ranges from 0.1 to 0.15 mg/kg (2 to 3 mL), depending on the patient's height and clinical condition. Lower doses are used for shorter or elderly patients, while taller patients may require higher doses to achieve the desired block level at T10-T12.
Group B (PENG Block Group):
Patients in this group will first receive a pericapsular nerve block (PENG) before spinal anesthesia.
The PENG block will be performed using a mixture of 0.25% bupivacaine (1.25 to 2.5 mg/kg.) combined with dexmedetomidine at a dose of 1.25 mcg/kg. This combination provides prolonged analgesia, enhances block effectiveness, and minimizes motor blockade, ensuring optimal pain control for fracture neck femur surgery.
Following the successful administration of the PENG block, spinal anesthesia will be administered as described for Group A.
2- Intraoperative Settings: Monitoring: Upon entering the operating room, standard monitoring will be applied to all patients, including pulse oximetry (SpO2), non-invasive blood pressure (NIBP), heart rate (HR), and electrocardiogram (ECG). Baseline measurements will be recorded before any anesthetic intervention.
Intravenous Access: An intravenous (IV) cannula will be inserted, and IV fluids will be initiated.
Group A (Control Group):
For spinal anesthesia in fracture neck femur surgery, a typical dose of 0.5% hyperbaric bupivacaine ranges from 0.1 to 0.15 mg/kg (2 to 3 mL), depending on the patient's height and clinical condition. Lower doses are used for shorter or elderly patients, while taller patients may require higher doses to achieve the desired block level at T10-T12.
Group B (PENG Block Group):
Patients in this group will first receive a pericapsular nerve block (PENG) before spinal anesthesia.
The PENG block will be performed using a mixture of 0.25% bupivacaine (1.25 to 2.5 mg/kg.) combined with dexmedetomidine at a dose of 1.25 mcg/kg. This combination provides prolonged analgesia, enhances block effectiveness, and minimizes motor blockade, ensuring optimal pain control for fracture neck femur surgery.
Following the successful administration of the PENG block, spinal anesthesia will be administered as described for Group A.
Study Oversight
Has Oversight DMC:
True
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?: