Role of Pericapsular Nerve Block Using Dexmedetomidine and Bupivacaine in Improving the Outcome of Patients Undergoing Hip Surgery Under Spinal Anesthesia

Ain Shams University

Status and phase: Completed; Phase 1

Conditions: Pain During Spinal Positioning

Treatments: Drug: Dexmedetomidin; Drug: Bupivacain

Study type: Interventional

Funder types: Other

Identifiers

NCT07149168

FMASU MS 760/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged ≥ 18 years, scheduled for elective fracture neck femur surgery, • Physical status: ASAI-III.

Exclusion criteria

• • Patients with contraindications to spinal anesthesia or regional blocks as:

  • significant coagulopathy

  • Known allergies to drugs used (Bupivacaine or dexmedetomidine)

  • Infection at site of injection

    • ASA IV
    • Cardiac patients with significant valve stenosis or sever pulmonary hypertension

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

control

Active Comparator group

Description:

patients will recieve 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

Treatment:

Drug: Bupivacain

group B

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidin