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.

NCT05751291 | Unknown

• 1 other identifier: Soh-Med-23-02-08
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

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.

Drug: Bupivacaine Hydrochloride

Group B

ACTIVE COMPARATOR

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.

Drug: Bupivacaine Hydrochloride

Interventions

Bupivacaine Hydrochloride 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 A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

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

  PMID: 14917714 BACKGROUND

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

  PMID: 18873153 BACKGROUND

• 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.

  PMID: 22344482 BACKGROUND

• 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.

  PMID: 29140962 BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Mustafa K Mohamed, Resident

CONTACT

01065674322; mostafakamal@med.sohag.edu.eg

Abdel Rahman H Abdel Rahman, Professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI 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 Record Dates

• First Submitted: February 20, 2023
• First Posted: March 2, 2023
• Study Start: March 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: February 1, 2024
• Last Updated: March 2, 2023

Record last verified: 2023-02

Locations

EG (1)