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Which Analgesia is Better for Proximal Femoral Fractures?

Primary Purpose

Proximal Femur Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fascia iliaca block
combined LFCN block with PENG block
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Proximal Femur Fracture

Eligibility Criteria

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

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status I, II and III.

Exclusion Criteria:

  • Patient refusal.
  • Neuromuscular diseases
  • Hematological diseases
  • Bleeding abnormality
  • Coagulation abnormality.
  • Psychiatric diseases.
  • Local skin infection at the site of the block.
  • Local skin 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, emergency hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fascia iliaca block

combined LFCN block with PENG block

Arm Description

Patients will receive Fascia iliaca block

Patients will receive a combined lateral femoral cutaneous nerve block with pericapsular nerve group block

Outcomes

Primary Outcome Measures

Time of performance of Spinal Anesthesia
Is defined as the time measured from the start of positioning to the completion of the intrathecal bupivacaine injection

Secondary Outcome Measures

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
Pain measurement during positioning for spinal anesthesia
visual analog scale (0-10, 0: no pain, 10: worst pain imaginable) during changing position from supine to sitting one
The severity of postoperative pain at rest
10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain
The severity of postoperative pain 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
Time to onset of Sensory blockade
cold perception loss in the lateral, anterior and medial part of the thigh (corresponding to lateral femoral cutaneous (LFC), femoral (F) and obturator (O)nerve sensory distributions, respectively)
Time to onset of motor block
defined as assessment of quadriceps femoris muscle strength by straight leg raise test to 15 degree and classified as follow: +ve =normal power, -ve =motor weakness
Duration of sensory block
blockade is defined as the interval between end of injection and complete end of sensory block (score=2)
Duration of motor block
blockade is defined as the interval between end of injection and complete end of injection and complete recovery of normal motor function (score=0),
Anesthesiology satisfaction for patient positioning
evaluated as 0=unsatisfactory, 1=satisfactory, 2=good or 3=optimal
heart rate
Changes in heart rate
Mean arterial blood pressure
Changes in Mean arterial blood pressure
Peripheral oxygen saturation
Changes in peripheral oxygen saturation as measured with pulse oximetry
Time for first analgesic request
defined as the time period from end of injection to the first time patient requests analgesia postoperatively
Total analgesics received
cumulative consumption of opioids during the first postoperative day
Pruritis
number of patients with pruritis
nausea
number of patients with nausea
vomiting
number of patients with vomiting

Full Information

First Posted
March 12, 2020
Last Updated
September 22, 2020
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT04309539
Brief Title
Which Analgesia is Better for Proximal Femoral Fractures?
Official Title
- Efficacy of Combined Lateral Femoral Cutaneous Nerve Block With Pericapsular Nerve Group Block Versus Fascia Iliaca Block in Proximal Femoral Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
March 2022 (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
This patient population is typically elderly and frail. They are at risk of adverse effects secondary to inadequate pain management such as prolonged admissions and poor functional outcomes. Regional analgesia is preferred due to their opioid-sparing effects and reduction in related adverse effects but The analgesia from these blocks is only moderate and literature suggests that the obturator nerve (ON) is not covered.
Detailed Description
The aim of this study is to compare the effect of combined lateral femoral cutaneous nerve block with pericapsular nerve group block versus fascia iliaca block for proximal femur surgery. Fascia iliaca compartment block is a simple technique to manage pain before positioning for spinal anesthesia performance and it constitutes a practical choice for perioperative pain control. 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 The high articular branches from FN and AON are consistently found between the anterior inferior iliac spine (AIIS) and the iliopubic eminence (IPE), whereas the ON is located close to the inferomedial acetabulum. The 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. Roy et al 2019 recommended the use of PENG block together with LFCN block as adjunctive to cover the lateral surgical incision.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Femur Fracture

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single-blind study
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fascia iliaca block
Arm Type
Active Comparator
Arm Description
Patients will receive Fascia iliaca block
Arm Title
combined LFCN block with PENG block
Arm Type
Active Comparator
Arm Description
Patients will receive a combined lateral femoral cutaneous nerve block with pericapsular nerve group block
Intervention Type
Procedure
Intervention Name(s)
Fascia iliaca block
Intervention Description
A linear probe will be placed in the sagittal plane to the inguinal ligament to obtain an image of "bow-tie sign" formed by the muscle fascias, a spinal needle will be inserted 1 cm cephalad Using an in-plane approach, the fascia iliaca is penetrated, 30 mL of bupivacaine 0.25% before spinal anesthesia.
Intervention Type
Procedure
Intervention Name(s)
combined LFCN block with PENG block
Intervention Description
With the patient supine, the linear probe is placed parallel to the inguinal ligament. LFCN appear as a hypoechoic oval structure between the tensor fascia lata and Sartorius muscles. The needle is inserted in plane. 5 mL of LA is injected. The PENG block will be performed in the supine position. A curvilinear probe will be placed transversely over the anterior inferior iliac spine and then rotated counterclockwise 45 degrees. the ilio pubic eminence, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be observed. A spinal needle will be inserted in plane to the plane between the psoas tendon and the pubic ramus. 25 mL of bupivacaine 0.25% will be injected
Primary Outcome Measure Information:
Title
Time of performance of Spinal Anesthesia
Description
Is defined as the time measured from the start of positioning to the completion of the intrathecal bupivacaine injection
Time Frame
just before surgery.
Secondary Outcome Measure Information:
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
immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.
Title
Pain measurement on movement
Description
(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
Time Frame
immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.
Title
Pain measurement during positioning for spinal anesthesia
Description
visual analog scale (0-10, 0: no pain, 10: worst pain imaginable) during changing position from supine to sitting one
Time Frame
Just before surgery
Title
The severity of postoperative pain 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
immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.
Title
The severity of postoperative pain on movement
Description
(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
Time Frame
immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.
Title
Time to onset of Sensory blockade
Description
cold perception loss in the lateral, anterior and medial part of the thigh (corresponding to lateral femoral cutaneous (LFC), femoral (F) and obturator (O)nerve sensory distributions, respectively)
Time Frame
evaluated 15 and 30 min after block administration
Title
Time to onset of motor block
Description
defined as assessment of quadriceps femoris muscle strength by straight leg raise test to 15 degree and classified as follow: +ve =normal power, -ve =motor weakness
Time Frame
evaluated 15 and 30 min after block administration
Title
Duration of sensory block
Description
blockade is defined as the interval between end of injection and complete end of sensory block (score=2)
Time Frame
postoperative 24 hours
Title
Duration of motor block
Description
blockade is defined as the interval between end of injection and complete end of injection and complete recovery of normal motor function (score=0),
Time Frame
postoperative 24 hours
Title
Anesthesiology satisfaction for patient positioning
Description
evaluated as 0=unsatisfactory, 1=satisfactory, 2=good or 3=optimal
Time Frame
just before surgery
Title
heart rate
Description
Changes in heart rate
Time Frame
pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery
Title
Mean arterial blood pressure
Description
Changes in Mean arterial blood pressure
Time Frame
pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery
Title
Peripheral oxygen saturation
Description
Changes in peripheral oxygen saturation as measured with pulse oximetry
Time Frame
pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery
Title
Time for first analgesic request
Description
defined as the time period from end of injection to the first time patient requests analgesia postoperatively
Time Frame
Within 24 hours after surgery
Title
Total analgesics received
Description
cumulative consumption of opioids during the first postoperative day
Time Frame
for 24 hrs after surgery
Title
Pruritis
Description
number of patients with pruritis
Time Frame
Within 24 hours after surgery
Title
nausea
Description
number of patients with nausea
Time Frame
Within 24 hours after surgery
Title
vomiting
Description
number of patients with vomiting
Time Frame
Within 24 hours after surgery

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: American Society of Anesthesiologists (ASA) physical status I, II and III. Exclusion Criteria: Patient refusal. Neuromuscular diseases Hematological diseases Bleeding abnormality Coagulation abnormality. Psychiatric diseases. Local skin infection at the site of the block. Local skin sepsis at the site of the block Known intolerance to the study drugs. Body Mass Index > 40 Kg/m2. Multiple trauma patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mona A Hasheesh, MD
Phone
00201027034020
Email
drmonahasheesh@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eiad A Ramzy, MD
Phone
00201005774079
Email
eiadramzy@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona A Hasheesh, MD
Organizational Affiliation
Professor of Anesthesia and Surgical Intensive care,,P
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eiad A Ramzy, MD
Organizational Affiliation
Associate Professor of Anesthesia and Surgical Intensive care,
Official's Role
Study Director
Facility Information:
Facility Name
Mansoura University, emergency hospital
City
Mansourah
State/Province
DK
ZIP/Postal Code
050
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mona A Hasheesh, MD
Phone
00201027034020
Email
drmonahasheesh@hotmail.com
First Name & Middle Initial & Last Name & Degree
Eyad A Ramzy, MD
Phone
00201005774079
Email
eiadramzy@yahoo.com
First Name & Middle Initial & Last Name & Degree
Sherin A Bakrey, MD
First Name & Middle Initial & Last Name & Degree
Shimaa A Shalaby, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Yes, Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
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

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Which Analgesia is Better for Proximal Femoral Fractures?

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