Combined Ultrasound and Fluoroscopy-guided Technique for Anterior Hip Denervation

Combined Ultrasound and Fluoroscopy-guided Technique for Treatment of Hip Pain. A Pilot Study for a Suggested Approach for Anterior Hip Denervation

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hip Fractures
• Intervention / Treatment: Procedure: Modified technique for pericapsular nerve group block

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.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansoura, DK, Egypt, 050
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Pericapsular nerve group block; combined ultrasound and fluoroscopy-guided technique for pericapsular nerve group block

Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of first skin puncture	Is defined as the number of getting the target point from the first skin puncture	just after skin puncture
The number of skin punctures:	Is defined as the total number of skin punctures for either getting the target point or not.	just after skin puncture for the block
the total number of needle passes required for obtaining the target landmark	Is defined as the total number of forward advancements of the spinal needle i.e. withdrawal and redirection without exiting the skin (sum of passes of all punctures).	just after skin puncture
The optimum volume of the injectate	Is defined as the optimum volume of the injectate to cover the target innervation area.	30 minutes before surgery.
Pain measurement at rest	10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain.	Prior to performing of nerve block, 15, 30 minutes after block performance
Pain measurement on movement (attempted hip flexion to 15 degrees):	10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain,	Prior to performing of nerve block, 15, 30 minutes after block performance
Incidence of block failed block	Is defined as less than 50% pain relief of pain i.e. (less than 50% of VAS score is reduced after the block	30 minutes after Local Anesthetic injection
Time for first analgesic request	the time passed from LA injection to the patient need of first analgesia	Within 24 hours after surgery
Patient satisfaction score	From zero=Poor, 1=fair, 2=good, 3=very good to 5=excellent	Within 24 hours after the nerve block
Complications:	presence or absence of unintentional vascular puncture, hematoma formation, parasthesia	Within 24 hours after the nerve block

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Mohamed Y Makharita, M.D., Professor of Anesthesia and Surgical Intensive Care; Principal Investigator: Shimaa Shalaby, M.Sec., Assistant lecturer of Anesthesia and Surgical Intensive Care

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 22, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures
• Other Study ID Numbers: MFM-IRB, R.21.05.1337

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: after completing the study and being accepted for publication.
• IPD Sharing Access Criteria: The data will be accessible to the investigators and PRS administrators with hiding the identifiers for the patients
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No