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Combined Ultrasound and Fluoroscopy-guided Technique for Anterior Hip Denervation

Primary Purpose

Hip Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Modified technique for pericapsular nerve group block
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hip Fractures

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mansoura University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pericapsular nerve group block

Arm Description

combined ultrasound and fluoroscopy-guided technique for pericapsular nerve group block

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Success rate of first skin puncture
Is defined as the number of getting the target point from the first skin puncture
The number of skin punctures:
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
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).
The optimum volume of the injectate
Is defined as the optimum volume of the injectate to cover the target innervation area.
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.
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,
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
Time for first analgesic request
the time passed from LA injection to the patient need of first analgesia
Patient satisfaction score
From zero=Poor, 1=fair, 2=good, 3=very good to 5=excellent
Complications:
presence or absence of unintentional vascular puncture, hematoma formation, parasthesia

Full Information

First Posted
June 22, 2021
Last Updated
June 22, 2021
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT04945668
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 2021 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pericapsular nerve group block
Arm Type
Other
Arm Description
combined ultrasound and fluoroscopy-guided technique for pericapsular nerve group block
Intervention Type
Procedure
Intervention Name(s)
Modified technique for pericapsular nerve group block
Intervention Description
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
Primary Outcome Measure Information:
Title
The success rate to target a suggested optimal landmark
Description
Is defined as the percentage of success to reach the target point for injection with needle punctures to up to 4 skin punctures.
Time Frame
just after skin puncture
Secondary Outcome Measure Information:
Title
Success rate of first skin puncture
Description
Is defined as the number of getting the target point from the first skin puncture
Time Frame
just after skin puncture
Title
The number of skin punctures:
Description
Is defined as the total number of skin punctures for either getting the target point or not.
Time Frame
just after skin puncture for the block
Title
the total number of needle passes required for obtaining the target landmark
Description
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 Frame
just after skin puncture
Title
The optimum volume of the injectate
Description
Is defined as the optimum volume of the injectate to cover the target innervation area.
Time Frame
30 minutes before surgery.
Title
Pain measurement at rest
Description
10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain.
Time Frame
Prior to performing of nerve block, 15, 30 minutes after block performance
Title
Pain measurement on movement (attempted hip flexion to 15 degrees):
Description
10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain,
Time Frame
Prior to performing of nerve block, 15, 30 minutes after block performance
Title
Incidence of block failed block
Description
Is defined as less than 50% pain relief of pain i.e. (less than 50% of VAS score is reduced after the block
Time Frame
30 minutes after Local Anesthetic injection
Title
Time for first analgesic request
Description
the time passed from LA injection to the patient need of first analgesia
Time Frame
Within 24 hours after surgery
Title
Patient satisfaction score
Description
From zero=Poor, 1=fair, 2=good, 3=very good to 5=excellent
Time Frame
Within 24 hours after the nerve block
Title
Complications:
Description
presence or absence of unintentional vascular puncture, hematoma formation, parasthesia
Time Frame
Within 24 hours after the nerve block

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Y Makharita, M.D.
Organizational Affiliation
Professor of Anesthesia and Surgical Intensive Care
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shimaa Shalaby, M.Sec.
Organizational Affiliation
Assistant lecturer of Anesthesia and Surgical Intensive Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University
City
Mansoura
State/Province
DK
ZIP/Postal Code
050
Country
Egypt

12. IPD Sharing Statement

Plan to Share 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

Learn more about this trial

Combined Ultrasound and Fluoroscopy-guided Technique for Anterior Hip Denervation

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