search
Back to results

Comparative Study to Evaluate the Efficacy of Ultrasound-Guided Pericapsular Nerve Group (PENG) Block Versus Fascia Iliaca Compartment (FIC) Block on the Postoperative Analgesic Effect in Patients Undergoing Hip Surgeries Under Spinal Anesthesia.

Primary Purpose

Hip Fractures

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine Hydrochloride
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Forty -Two patients above 18 years of age belonging to the American Society of Anaesthesiologists (ASA) physical status Classes I and II scheduled for hip surgery will randomly be allocated into two groups. Group A (PENG block) will receive US - guided PENG block and Group B (FIC block) will receive US - guided FIC block for postoperative pain relief. Exclusion Criteria: Patient refusal. Patient with significant neurological, psychiatric or neuromuscular disease. Alcoholism. Drug abuse. Pregnancy or lactating women. Suspected Coagulopathy. Morbid obesity. Known allergy to study medications. Septicemia and local infection at the block site.

Sites / Locations

  • Sohag University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Arm Description

Group A (PENG block) patients will receive PENG block under ultrasound-guided (USG) guidance using curvilinear low-frequency ultrasound probe (2-5 MHz) will initially be 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 to visualize the Iliopubic Eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle. A 22 Gauge needle will be inserted in-plane and the needle tip will be positioned in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. 20 mL of 0.25% bupivacaine will be injected in increments while observing for an adequate fluid spread in this plane.

Group B (FIC) patients will receive FIC block under USG guidance using high-frequency linear transducer (6-13 MHz) will be used to identify the femoral artery at the level of the inguinal crease. Immediately lateral and deep to the femoral artery and vein the iliopsoas muscle is overlaid by a hyperechoic fascia iliaca. The femoral nerve is seen lateral to the femoral artery wedged between the iliopsoas muscle and the fascia iliaca. Maneuvering the transducer laterally helps to visualize the Sartorius muscle covered by its own fascia alongside the fascia iliaca. A line is drawn connecting the anterior superior iliac spine to the pubic tubercle; the needle tip is positioned at lateral third of the line under the fascia iliaca. 20 mL of 0.25% bupivacaine will be injected until it spreads laterally toward the iliac spine and medially toward the femoral nerve.

Outcomes

Primary Outcome Measures

Comparison between duration of analgesia of Pericapsular Nerve Group (PENG) Block vs Fascia Iliaca Compartment (FIC) Block.
Comparison between duration of analgesia of Pericapsular Nerve Group (PENG) Block vs Fascia Iliaca Compartment (FIC) Block.

Secondary Outcome Measures

Full Information

First Posted
February 20, 2023
Last Updated
February 20, 2023
Sponsor
Sohag University
search

1. Study Identification

Unique Protocol Identification Number
NCT05751291
Brief Title
Comparative Study to Evaluate the Efficacy of Ultrasound-Guided Pericapsular Nerve Group (PENG) Block Versus Fascia Iliaca Compartment (FIC) Block on the Postoperative Analgesic Effect in Patients Undergoing Hip Surgeries Under Spinal Anesthesia.
Official Title
Comparative Study to Evaluate the Efficacy of Ultrasound-Guided Pericapsular Nerve Group (PENG) Block Versus Fascia Iliaca Compartment (FIC) Block on the Postoperative Analgesic Effect in Patients Undergoing Hip Surgeries Under Spinal Anesthesia.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

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
Fractures in and around the hip are quite common irrespective of both the young and elderly population groups and are associated with extreme pain. A hip fracture is a serious injury, with complications that can be life-threatening and is a common orthopedic emergency in the elderly. Early surgery within 48 h of fracture has shown to decrease the complication and mortality rates.

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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Group A (PENG block) patients will receive PENG block under ultrasound-guided (USG) guidance using curvilinear low-frequency ultrasound probe (2-5 MHz) will initially be 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 to visualize the Iliopubic Eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle. A 22 Gauge needle will be inserted in-plane and the needle tip will be positioned in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. 20 mL of 0.25% bupivacaine will be injected in increments while observing for an adequate fluid spread in this plane.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Group B (FIC) patients will receive FIC block under USG guidance using high-frequency linear transducer (6-13 MHz) will be used to identify the femoral artery at the level of the inguinal crease. Immediately lateral and deep to the femoral artery and vein the iliopsoas muscle is overlaid by a hyperechoic fascia iliaca. The femoral nerve is seen lateral to the femoral artery wedged between the iliopsoas muscle and the fascia iliaca. Maneuvering the transducer laterally helps to visualize the Sartorius muscle covered by its own fascia alongside the fascia iliaca. A line is drawn connecting the anterior superior iliac spine to the pubic tubercle; the needle tip is positioned at lateral third of the line under the fascia iliaca. 20 mL of 0.25% bupivacaine will be injected until it spreads laterally toward the iliac spine and medially toward the femoral nerve.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Intervention Description
Pericapsular Nerve Group (PENG) Block: 20 mL of 0.25% bupivacaine will be injected in increments while observing for an adequate fluid spread in this plane. Fascia Iliaca Compartment (FIC) Block: 20 mL of 0.25% bupivacaine will be injected until it spreads. laterally toward the iliac spine and medially toward the femoral nerve.
Primary Outcome Measure Information:
Title
Comparison between duration of analgesia of Pericapsular Nerve Group (PENG) Block vs Fascia Iliaca Compartment (FIC) Block.
Description
Comparison between duration of analgesia of Pericapsular Nerve Group (PENG) Block vs Fascia Iliaca Compartment (FIC) Block.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Forty -Two patients above 18 years of age belonging to the American Society of Anaesthesiologists (ASA) physical status Classes I and II scheduled for hip surgery will randomly be allocated into two groups. Group A (PENG block) will receive US - guided PENG block and Group B (FIC block) will receive US - guided FIC block for postoperative pain relief. Exclusion Criteria: Patient refusal. Patient with significant neurological, psychiatric or neuromuscular disease. Alcoholism. Drug abuse. Pregnancy or lactating women. Suspected Coagulopathy. Morbid obesity. Known allergy to study medications. Septicemia and local infection at the block site.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mustafa K Mohamed, Resident
Phone
01065674322
Email
mostafakamal@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Abdel Rahman H Abdel Rahman, Professor
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy M Amin, Professor

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
14917714
Citation
WERTHEIMER LG. The sensory nerves of the hip joint. J Bone Joint Surg Am. 1952 Apr;34-A(2):477-87. No abstract available.
Results Reference
background
PubMed Identifier
18873153
Citation
GARDNER E. The innervation of the hip joint. Anat Rec. 1948 Jul;101(3):353-71. doi: 10.1002/ar.1091010309. No abstract available.
Results Reference
background
PubMed Identifier
22344482
Citation
Gerhardt M, Johnson K, Atkinson R, Snow B, Shaw C, Brown A, Vangsness CT Jr. Characterisation and classification of the neural anatomy in the human hip joint. Hip Int. 2012 Jan-Feb;22(1):75-81. doi: 10.5301/HIP.2012.9042.
Results Reference
background
PubMed Identifier
29140962
Citation
Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701.
Results Reference
background

Learn more about this trial

Comparative Study to Evaluate the Efficacy of Ultrasound-Guided Pericapsular Nerve Group (PENG) Block Versus Fascia Iliaca Compartment (FIC) Block on the Postoperative Analgesic Effect in Patients Undergoing Hip Surgeries Under Spinal Anesthesia.

We'll reach out to this number within 24 hrs