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Clinical Trials/NCT04945668
NCT04945668
Unknown
Not Applicable

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

Mansoura University1 site in 1 country16 target enrollmentStarted: July 2021Last updated:
ConditionsHip Fractures

Overview

Phase
Not Applicable
Enrollment
16
Locations
1
Primary Endpoint
The success rate to target a suggested optimal landmark

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
50 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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/m
  • Multiple trauma patients.

Outcomes

Primary Outcomes

The success rate to target a suggested optimal landmark

Time Frame: 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 Outcomes

  • Success rate of first skin puncture(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)
  • Pain measurement on movement (attempted hip flexion to 15 degrees):(Prior to performing of nerve block, 15, 30 minutes after block performance)
  • Incidence of block failed block(30 minutes after Local Anesthetic injection)
  • 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)
  • Time for first analgesic request(Within 24 hours after surgery)
  • Patient satisfaction score(Within 24 hours after the nerve block)
  • Complications:(Within 24 hours after the nerve block)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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