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.

NCT ID: NCT05751291

Last Updated: 2023-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hip Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

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 Type ACTIVE_COMPARATOR

Bupivacaine Hydrochloride

Intervention Type DRUG

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.

Group B

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.

Group Type ACTIVE_COMPARATOR

Bupivacaine Hydrochloride

Intervention Type DRUG

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.

Interventions

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Bupivacaine Hydrochloride

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mostafa Kamed Mohamed

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.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Mustafa K Mohamed, Resident

Role: CONTACT

01065674322

Abdel Rahman H Abdel Rahman, Professor

Role: CONTACT

Facility Contacts

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Magdy M Amin, Professor

Role: primary

References

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WERTHEIMER LG. The sensory nerves of the hip joint. J Bone Joint Surg Am. 1952 Apr;34-A(2):477-87. No abstract available.

Reference Type BACKGROUND
PMID: 14917714 (View on PubMed)

GARDNER E. The innervation of the hip joint. Anat Rec. 1948 Jul;101(3):353-71. doi: 10.1002/ar.1091010309. No abstract available.

Reference Type BACKGROUND
PMID: 18873153 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22344482 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29140962 (View on PubMed)

Other Identifiers

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Soh-Med-23-02-08

Identifier Type: -

Identifier Source: org_study_id

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