Combined Ultrasound and Fluoroscopy-guided Technique for Anterior Hip Denervation

NCT ID: NCT04945668

Last Updated: 2021-06-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-31
• Study Completion Date: 2021-10-31

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.

Detailed Description

The aim of this study is to help to target a suggested optimum landmark and determine the volume of injectate that can cover the distribution of the anterior articular branches supplying the hip joint.

The anterior hip capsule is innervated by the ON, accessory obturator nerve (AON), and FN as reported by previous anatomic studies. The anterior capsule is the most richly innervated section of the joint.

Ultrasound-guided technique for blockade of these articular branches to the hip, the PENG (Pericapsular Nerve Group) block reported significantly reduced pain scores compared with baseline.

With the current understanding of the complex innervations of the hip joint, it is difficult to provide complete effective radiofrequency ablation to the articular branches supplying the hip joint. Chemical hip denervation using ultrasound was reported by previous case reports or series without mentioning a well-defined target point or an optimum injectate volume.

Conditions

Hip Fractures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Pericapsular nerve group block

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

Group Type: OTHER

Modified technique for pericapsular nerve group block

Intervention Type: 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

Interventions

Modified technique for pericapsular nerve group block

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed Y Makharita, M.D.

Role: STUDY_CHAIR

Professor of Anesthesia and Surgical Intensive Care

Shimaa Shalaby, M.Sec.

Role: PRINCIPAL_INVESTIGATOR

Assistant lecturer of Anesthesia and Surgical Intensive Care

Locations

Mansoura University

Al Mansurah, DK, Egypt

Countries

Egypt

Other Identifiers

MFM-IRB, R.21.05.1337

Identifier Type: -

Identifier Source: org_study_id