Combined Ultrasound and Fluoroscopy-guided Technique for Anterior Hip Denervation

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04945668
• Other study ID #: MFM-IRB, R.21.05.1337
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 2021
• Est. completion date: October 2021

Study information

• Verified date: June 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 16
• Est. completion date: October 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hip Fractures

Intervention

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

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	Time for first analgesic request	the time passed from LA injection to the patient need of first analgesia	Within 24 hours after surgery
Secondary	Patient satisfaction score	From zero=Poor, 1=fair, 2=good, 3=very good to 5=excellent	Within 24 hours after the nerve block
Secondary	Complications:	presence or absence of unintentional vascular puncture, hematoma formation, parasthesia	Within 24 hours after the nerve block