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

NCT07149168 | Completed Phase 1 DMC

• 1 other identifier: FMASU MS 760/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain During Spinal Positioning

Outcome Measures

Primary Outcomes (1)

• The success rate of achieving adequate spinal anesthesia.

  from injection to 24 hr post operative

Study Arms (2)

control

ACTIVE COMPARATOR

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

Drug: Bupivacain

group B

ACTIVE COMPARATOR

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.

Drug: Dexmedetomidin

Interventions

Dexmedetomidin DRUG

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

group B

Bupivacain DRUG

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

control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11111, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Bupivacaine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Dina Sameer Ahmed AboRaya

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2025
• First Posted: August 29, 2025
• Study Start: December 10, 2024
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: August 29, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: before 1/2026
• Access Criteria: free

Locations

EG (1)