Combined Ultrasound and Fluoroscopy-guided Technique for Anterior Hip Denervation

NCT04945668 | Unknown DMC

• 1 other identifier: MFM-IRB, R.21.05.1337
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Hip fracture is a challenging geriatric problem for health care professionals, especially in patients with multiple comorbidities. In patients with inoperable hip fractures secondary to severe comorbid conditions, the pain can lead to significant challenges in nursing care. A recent anatomical study confirmed the innervation of the anterior hip by these 3 main nerves but also found that the AON and FN play a greater role in the anterior hip innervation than previously reported.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• The success rate to target a suggested optimal landmark

  Is defined as the percentage of success to reach the target point for injection with needle punctures to up to 4 skin punctures.

  just after skin puncture

Secondary Outcomes (10)

• Success rate of first skin puncture

  just after skin puncture

• The number of skin punctures:

  just after skin puncture for the block

• the total number of needle passes required for obtaining the target landmark

  just after skin puncture

• The optimum volume of the injectate

  30 minutes before surgery.

• Pain measurement at rest

  Prior to performing of nerve block, 15, 30 minutes after block performance

Study Arms (1)

Pericapsular nerve group block

OTHER

combined ultrasound and fluoroscopy-guided technique for pericapsular nerve group block

Procedure: Modified technique for pericapsular nerve group block

Interventions

Modified technique for pericapsular nerve group block PROCEDURE

with the patient in the supine position, ultrasound probe in a transverse plane over the anterior inferior iliac spine (AIIS) and then aligned with the pubic ramus. In this view, the ilio pubic eminence (IPE), the iliopsoas muscle and tendon will be observed. A spinal needle will be inserted from lateral to medial in an in-plane approach to place the tip between the psoas tendon and the pubic ramus. Fluoroscopic image will be taken to confirm the needle tip position in the target site. Following negative aspiration, 15 ml dye will be injected in 5-mL increments while observing for adequate spread using fluoroscopy followed by 15ml local anesthetic

Pericapsular nerve group block

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I, II, and III.
• Patients scheduled for elective or emergent hip fractures.

You may not qualify if:

• Patient refusal.
• Neuromuscular diseases (as myopathies, myasthenia gravies…)
• Hematological diseases, bleeding, or coagulation abnormality.
• Psychiatric diseases.
• Local skin infection and sepsis at the site of the block.
• Known intolerance to the study drugs.
• Body Mass Index \> 40 Kg/m2.
• Multiple trauma patients.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Mohamed Y Makharita, M.D.

  Professor of Anesthesia and Surgical Intensive Care

  STUDY CHAIR

• Shimaa Shalaby, M.Sec.

  Assistant lecturer of Anesthesia and Surgical Intensive Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: June 30, 2021
• Study Start: July 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after completing the study and being accepted for publication.
• Access Criteria: The data will be accessible to the investigators and PRS administrators with hiding the identifiers for the patients

Locations

EG (1)