Clinical trial NCT04945668: Combined Ultrasound and Fluoroscopy-guided Technique for Anterior Hip Denervation
Official title: Combined Ultrasound and Fluoroscopy-guided Technique for Treatment of Hip Pain. A Pilot Study for a Suggested Approach for Anterior Hip Denervation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fractures
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: The success rate to target a suggested optimal landmark
timeFrame: just after skin puncture
Secondary outcomes:
measure: Success rate of first skin puncture
timeFrame: just after skin puncture
measure: The number of skin punctures:
timeFrame: just after skin puncture for the block
measure: the total number of needle passes required for obtaining the target landmark
timeFrame: just after skin puncture
measure: The optimum volume of the injectate
timeFrame: 30 minutes before surgery.
measure: Pain measurement at rest
timeFrame: Prior to performing of nerve block, 15, 30 minutes after block performance
measure: Pain measurement on movement (attempted hip flexion to 15 degrees):
timeFrame: Prior to performing of nerve block, 15, 30 minutes after block performance
measure: Incidence of block failed block
timeFrame: 30 minutes after Local Anesthetic injection
measure: Time for first analgesic request
timeFrame: Within 24 hours after surgery
measure: Patient satisfaction score
timeFrame: Within 24 hours after the nerve block
measure: Complications:
timeFrame: Within 24 hours after the nerve block
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: DK
Study officials:
affiliation: Professor of Anesthesia and Surgical Intensive Care
name: Mohamed Y Makharita, M.D.
role: STUDY_CHAIR
affiliation: Assistant lecturer of Anesthesia and Surgical Intensive Care
name: Shimaa Shalaby, M.Sec.
role: PRINCIPAL_INVESTIGATOR
References: