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Ultrasound Percapsular Nerve Group Block VS Fascia Iliaca Block for Hip Fracture

Primary Purpose

Hip Fracture, Analgesia, Acute Pain

Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
fascia iliaca block
percapsular nerve group block
Sponsored by
University Tunis El Manar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture focused on measuring hip fracture, nerve block, spinal anesthesia, analgesia

Eligibility Criteria

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

Inclusion Criteria:

  • - Patients aged ≥ 65 years old and undergoing hip fracture surgical repair under continuous spinal anesthesia (CSA).
  • Patients for whom pain was felt when raising the affected limb to 15 degrees (VERBAL PAIN SCALE =2)

Exclusion Criteria:

  • - ASA physical status ≥ 4.
  • Impaired cognition or Dementia.
  • Multiple fractures.
  • Contraindication to regional anesthesia.
  • Patient's disapproval.

Sites / Locations

  • Institut Kassab D'Orthopedie

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

fascial iliaca

Percapsular nerve group block

Arm Description

: A linear high frequency ultrasound probe (10-15MHz) was placed in a transverse direction over the anterior thigh below the inguinal ligament. We identified the femoral artery and the iliacus muscle lateral to it, covered by the fascia iliaca. The needle was inserted in plane and a 22 gauge, 50 mm needle was advanced until the tips placed underneath the fascia iliaca. Following negative aspiration, the local anesthetic solution was injected in 5mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL of 1.5% Lidocaine

A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the anterior inferior iliac spine (AIIS) and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the iliopubic eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 100-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic solution was injected in 5 mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL of 1.5% Lidocaine.

Outcomes

Primary Outcome Measures

positioning pain
Verbal Rating Scale (VRS) [0=no pain ; 4=worst pain]

Secondary Outcome Measures

Positioning Rating
verbal rating scale (VRS) [0=no pain ; 4=worst pain]
Imaging time
For the PENG block:the femoral artery, the anterior inferior iliac spine, the iliopubic eminence and the psoas tendon. For the FIB: the femoral artery, the iliacus muscle, the fascia iliaca and the fascia lata.
Puncture time
the time that stretches from the introduction of the needle until the end of the injection of local anesthetic
Performance time
the imaging time + time to puncture.
Number of punctures
the number of redirection of the needle after removing 2 cm.
pain 5 after block
verbal rating scale (VRS) [0=no pain ; 4=worst pain]
pain 10 after block
verbal rating scale (VRS) [0=no pain ; 4=worst pain]
pain 15 after block
verbal rating scale (VRS) [0=no pain ; 4=worst pain]
pain 20 after block
verbal rating scale (VRS) [0=no pain ; 4=worst pain]

Full Information

First Posted
February 9, 2020
Last Updated
June 16, 2020
Sponsor
University Tunis El Manar
Collaborators
Institut Kassab d'Orthopédie
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1. Study Identification

Unique Protocol Identification Number
NCT04285333
Brief Title
Ultrasound Percapsular Nerve Group Block VS Fascia Iliaca Block for Hip Fracture
Official Title
Analgesic Techniques Before Spinal Anesthesia for Hip Fracture Repair: Ultrasound Percapsular Nerve Group Block VS Fascia Iliaca Block
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 17, 2020 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Tunis El Manar
Collaborators
Institut Kassab d'Orthopédie

4. Oversight

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

5. Study Description

Brief Summary
Spinal anesthesia (SA) is a widely accepted anesthetic technique for hip fracture repair among elderly. Positioning for SA can be extremely painful. Effective management of pain is important for these patients comfort. Fascia Iliaca block (FIB) and Femoral nerve blocks are commonly used for analgesia in hip fracture patients. However, they often provide a modest reduction in pain. The Percapsular Nerve Group block (PENG Block) has the advantage that it covers the accessory obturator nerve. Aim of the study: compare FIB with PENG prior to positioning hip fracture patients for standardized SA. In a prospective randomized double blind we included 80 patients aged more than 65 years old, for whom pain was felt when raising the affected limb to 15 degrees. Patients were assigned to receive either ultrasound guided Fascia Iliaca block or Percapsular Nerve Group block using 20 mL Lidocaine 1.5% in both groups. We compared pain on positioning for spinal anesthesia using Verbal Rating Scale (VRS 0 = no pain , VRS 1 = mild pain, t 2= severe pain) for both groups. We also recorded different times to perfom block.
Detailed Description
The purpose of the study was to compare analgesis effect of Percapsula nerve group block to fascia iliaca block prior to positioning hip fracture patients for standardized SA. We included 80 patients reporting pain with Verbal Rating Scale at 2 when raising the affected limb to 15 degrees. All patients admitted to induction room, were given standard monitoring and we randomized to receive either: ultrasound fascia iliaca block using linear high frequency ultrasound probe (10-15MHz) placed in a transverse direction over the anterior thigh below the inguinal ligament. A 50 mm needle was advanced until the tips placed underneath the fascia iliaca and 20 mL 1.5% Lidocaine was injected or ultrasound Percapsula nerve group block A curvilinear using low-frequency ultrasound probe (2-5MHz) that was initially placed in a transverse plane over the anterior inferior iliac spine and then aligned with the pubic ramus by rotating the probe counter clockwise approximately 45 degrees. In this view, the iliopubic eminence , the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed and than a 100 mm needle was advanced to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly and 20 mL 1.5% Lidocaine.We compared pain on positioning for spinal anesthesia and also different time to realise both blocks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture, Analgesia, Acute Pain
Keywords
hip fracture, nerve block, spinal anesthesia, analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomised single blinded study
Masking
ParticipantCare Provider
Masking Description
all blocks were performed in a special area outside operating room by docters only implicated in performance assessement of block and not in patient care. Patients where after moved to operating room, care provider wil assess pain before spinal anesthesia
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fascial iliaca
Arm Type
Active Comparator
Arm Description
: A linear high frequency ultrasound probe (10-15MHz) was placed in a transverse direction over the anterior thigh below the inguinal ligament. We identified the femoral artery and the iliacus muscle lateral to it, covered by the fascia iliaca. The needle was inserted in plane and a 22 gauge, 50 mm needle was advanced until the tips placed underneath the fascia iliaca. Following negative aspiration, the local anesthetic solution was injected in 5mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL of 1.5% Lidocaine
Arm Title
Percapsular nerve group block
Arm Type
Experimental
Arm Description
A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the anterior inferior iliac spine (AIIS) and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the iliopubic eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 100-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic solution was injected in 5 mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL of 1.5% Lidocaine.
Intervention Type
Procedure
Intervention Name(s)
fascia iliaca block
Other Intervention Name(s)
BIF for hip fracture
Intervention Description
ultrasound guided block with 20 mL lidocaine 1.5%
Intervention Type
Procedure
Intervention Name(s)
percapsular nerve group block
Other Intervention Name(s)
PENG block for hip fracture
Intervention Description
ultrasound guided block with 20 mL lidocaine 1.5%
Primary Outcome Measure Information:
Title
positioning pain
Description
Verbal Rating Scale (VRS) [0=no pain ; 4=worst pain]
Time Frame
up to 30 minutes
Secondary Outcome Measure Information:
Title
Positioning Rating
Description
verbal rating scale (VRS) [0=no pain ; 4=worst pain]
Time Frame
up to 40 minutes
Title
Imaging time
Description
For the PENG block:the femoral artery, the anterior inferior iliac spine, the iliopubic eminence and the psoas tendon. For the FIB: the femoral artery, the iliacus muscle, the fascia iliaca and the fascia lata.
Time Frame
up to 10 minutes
Title
Puncture time
Description
the time that stretches from the introduction of the needle until the end of the injection of local anesthetic
Time Frame
up to 10 minutes
Title
Performance time
Description
the imaging time + time to puncture.
Time Frame
up to 10 minutes
Title
Number of punctures
Description
the number of redirection of the needle after removing 2 cm.
Time Frame
up to 10 minutes
Title
pain 5 after block
Description
verbal rating scale (VRS) [0=no pain ; 4=worst pain]
Time Frame
up to 5 minutes
Title
pain 10 after block
Description
verbal rating scale (VRS) [0=no pain ; 4=worst pain]
Time Frame
up to 10 minutes
Title
pain 15 after block
Description
verbal rating scale (VRS) [0=no pain ; 4=worst pain]
Time Frame
up to 15 minutes
Title
pain 20 after block
Description
verbal rating scale (VRS) [0=no pain ; 4=worst pain]
Time Frame
up to 20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Patients aged ≥ 65 years old and undergoing hip fracture surgical repair under continuous spinal anesthesia (CSA). Patients for whom pain was felt when raising the affected limb to 15 degrees (VERBAL PAIN SCALE =2) Exclusion Criteria: - ASA physical status ≥ 4. Impaired cognition or Dementia. Multiple fractures. Contraindication to regional anesthesia. Patient's disapproval.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
khaireddine Raddaoui, MD
Organizational Affiliation
Tunis El Manar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Kassab D'Orthopedie
City
Tunis
ZIP/Postal Code
2010
Country
Tunisia

12. IPD Sharing Statement

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Ultrasound Percapsular Nerve Group Block VS Fascia Iliaca Block for Hip Fracture

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