Combined Ultrasound and Fluoroscopy-guided Technique for Anterior Hip Denervation

Not Applicable

• Conditions: Hip Fractures
• Interventions: Procedure: Modified technique for pericapsular nerve group block

• Registration Number: NCT04945668
• Lead Sponsor: Mansoura University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-06-22
• Last Update Submitted: 2021-06-22
• Study First Posted: 2021-06-30
• Last Update Posted: 2021-06-30
• Study Start: 2021-07
• Primary Completion: 2021-09
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pericapsular nerve group block	Modified technique for pericapsular nerve group block	combined ultrasound and fluoroscopy-guided technique for pericapsular nerve group block

Primary Outcome Measures

Name	Time	Method
The success rate to target a suggested optimal landmark	just after skin puncture	Is defined as the percentage of success to reach the target point for injection with needle punctures to up to 4 skin punctures.

Secondary Outcome Measures

Name	Time	Method
Success rate of first skin puncture	just after skin puncture	Is defined as the number of getting the target point from the first skin puncture
The optimum volume of the injectate	30 minutes before surgery.	Is defined as the optimum volume of the injectate to cover the target innervation area.
Pain measurement at rest	Prior to performing of nerve block, 15, 30 minutes after block performance	10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain.
Pain measurement on movement (attempted hip flexion to 15 degrees):	Prior to performing of nerve block, 15, 30 minutes after block performance	10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain,
Incidence of block failed block	30 minutes after Local Anesthetic injection	Is defined as less than 50% pain relief of pain i.e. (less than 50% of VAS score is reduced after the block
The number of skin punctures:	just after skin puncture for the block	Is defined as the total number of skin punctures for either getting the target point or not.
the total number of needle passes required for obtaining the target landmark	just after skin puncture	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).
Time for first analgesic request	Within 24 hours after surgery	the time passed from LA injection to the patient need of first analgesia
Patient satisfaction score	Within 24 hours after the nerve block	From zero=Poor, 1=fair, 2=good, 3=very good to 5=excellent
Complications:	Within 24 hours after the nerve block	presence or absence of unintentional vascular puncture, hematoma formation, parasthesia

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, DK, Egypt