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Pericapsular Nerve Group Block for Hip Fractures

Primary Purpose

Hip Fractures, Pain, Acute

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pericapsular Nerve Group Block
Sponsored by
Jacobi Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hip Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • >18 years old (male or female)
  • cognitive intact patients with Isolated hip fractures (both surgical and non-surgical candidates)
  • displaced/non-displaced displaced/non-displaced sub-trochanteric
  • displaced/non-displaced intra-trochanteric
  • displaced/non-displaced femoral neck/head fractures

Exclusion Criteria:

  • patient refusal
  • allergy to local anesthetic
  • overlying infection at injection site
  • patients who cannot provide consent.

Sites / Locations

  • Jacobi Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peripheral Nerve Block (PENG)

Arm Description

Patients will receive the Pericapsular Nerve Group Block.

Outcomes

Primary Outcome Measures

Pain Scores
Visual Analog Pain Scale (VAS) from 0-10 with higher scores indicating worsening pain

Secondary Outcome Measures

Full Information

First Posted
May 8, 2021
Last Updated
March 18, 2022
Sponsor
Jacobi Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04882384
Brief Title
Pericapsular Nerve Group Block for Hip Fractures
Official Title
Pericapsular Nerve Group Blocks for Hip Fractures in the Emergency Department: A Prospective, Observational, Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
March 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jacobi Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This will be a feasibility study to see if it feasible to perform the Pericapsular Nerve Group Block for hip fractures in the Emergency Department. In addition, we will look at the efficacy of the block in these 10 patients by measuring pain scores at pre-determine time points for 16 hours.
Detailed Description
Isolated hip fractures are common and are associated with significant morbidity and mortality.1 2 The American Academy of Orthopedics provides strong evidence for peripheral nerve blocks as a safe, effective method to manage perioperative analgesia. Literature shows that peripheral nerve blocks decrease the need for opioids and its deleterious effects including respiratory depression and delirium, and can provide superior pain control when compared to parenteral analgesia.2-10 In addition to significant pain, patients with isolated hip fractures are at risk for underassessment of pain and subject to considerable delays in analgesic administration even after their pain is identified, in one study the average delay to treatment was 122 minutes.11 Ultrasound guidance has been shown to be a safe method for performing a peripheral nerve block.12 Overall, peripheral nerve blocks are a safe procedure with rare complications of nerve injury or local anesthetic toxicity.12,13 While the femoral nerve block, the "3-in-1" block, and the fascia iliaca block are popular analgesic approaches to hip fractures, they have their downsides. Literature suggests that these blocks provide inconsistent and partial analgesia.2,15, 16 A possible explanation is demonstrated by both MRI and cadaver studies that illustrate that the obturator nerve (sensory innervation) is rarely affected by these three blocks and can cause motor weakness. The potential benefit of a pericapsular nerve group (PENG) block is that its effect is sensory, while preserving motor function. The target of the PENG block, the anterior zone of the hip, contains the highest relative concentration of sensory fibers to the hip. This part of the labrum is innervated by articular branches of the femoral nerve (FN), accessory obturator nerve (AON) and obturator nerve (ON).2 17-20 The PENG block is a novel approach described by Giron-Arango et al in 2018 as an ultrasound guided technique to target the FN, AON, and ON.2 By targeting the articular branches of these three nerves as they course between the anterior inferior iliac spine and the iliopubic eminence (IPE), the PENG block is able to provide a sensory-only blockade without causing motor weakness.2 21-23 Currently, there are case series/reports showing that the PENG block is highly efficacious for pain. Aim/Objectives: We intend to conduct a feasibility study among 10 emergency department (ED) patients with hip fractures to determine logistical barriers to introducing a new procedure in an ED as well as to assessing pain and efficacy of the PENG block. Study Design: This study will take place in the Jacobi Adult ED. This will be a 10-patient prospective, observational, feasibility study regarding the PENG block for hip fractures in adults. The emergency physician (EP) will identify 10 cognitively intact patients with hip fractures in the ED. The EP has the option to provide a standard dose of intravenous narcotics during the initial assessment if clinically warranted until radiographic confirmation of a fracture. Once a fracture has been confirmed, the research team will be contacted. The patient will be enrolled into the study if they had a pain score greater than or equal to 5/10 at triage or upon initial EP evaluation before the intravenous analgesia, if there was no pre-hospital analgesia given, and if there are no concomitant injuries. To be included into the study, the patient will be alert, oriented to person, place, and time, and must be able to demonstrate understanding of the written consent form. Patient also has to be able to indicate how much pain they are in using a visual analog pain scale, with 0 being no pain and 10 being severe pain, and be able to report any side effects experienced after administration of the nerve blockade. If the patient refuses to be in the study, it will not hinder the patient from obtaining other avenues of pain management and all other care. The pain score assessed just before the nerve block will be considered time 0. The blocks will be performed with dynamic sonographic guidance using a Sonosite X-porte machine and the curvilinear transducer using sterile technique. EP were trained on the PENG block after a workshop series consisting on a lecture and three hands- on training using a low-fidelity model. Competency was determined once the participant successfully performed the block on the low-fidelity model without intervention by the trainer. They also had to pass a three part check list, including taking consent and verbalizing aseptic technique, and scoring > 90% on a multiple choice quiz. Patients are eligible to receive standardized rescue doses of intravenous narcotics after the PENG block if they experience continued pain. Pain scores will be assessed for 16 hours at pre-determined points.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peripheral Nerve Block (PENG)
Arm Type
Experimental
Arm Description
Patients will receive the Pericapsular Nerve Group Block.
Intervention Type
Procedure
Intervention Name(s)
Pericapsular Nerve Group Block
Intervention Description
This will be a peripheral nerve block.
Primary Outcome Measure Information:
Title
Pain Scores
Description
Visual Analog Pain Scale (VAS) from 0-10 with higher scores indicating worsening pain
Time Frame
16 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >18 years old (male or female) cognitive intact patients with Isolated hip fractures (both surgical and non-surgical candidates) displaced/non-displaced displaced/non-displaced sub-trochanteric displaced/non-displaced intra-trochanteric displaced/non-displaced femoral neck/head fractures Exclusion Criteria: patient refusal allergy to local anesthetic overlying infection at injection site patients who cannot provide consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Halperin
Organizational Affiliation
Jacobi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19826027
Citation
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Results Reference
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Citation
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Results Reference
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Pericapsular Nerve Group Block for Hip Fractures

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