Comparison of the Effects of Pericapsular Nerve Group (PENG), Suprainguinal Fascia Iliaca Compartment (S-FICB) and 3-1 Blocks on Comfort in Positioning for Unilateral Spinal Anesthesia and Postoperative Pain in Hip Fracture Surgery

NCT05912101 | Unknown

• 1 other identifier: 2022/49 ArdaTez
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Hip fracture is a common cause of surgery, especially in elderly patients. Unilateral spinal anesthesia in hip fracture surgery can prevent the undesirable effects of spinal anesthesia due to sympathetic blockade. However, severe pain in hip fracture patients limits the positioning required for unilateral spinal anesthesia. The sedation and analgesia required to position patients with fractured hip remains inferior may cause respiratory depression, hemodynamic instability or postoperative cognitive impairment, especially in elderly patients. Lower extremity peripheral blocks can be used preoperatively to minimize the use of sedatives that may be required during positioning and to provide effective and safe analgesia.

Conditions

Hip Fractures; Pain Management; Pain Postoperative; Spinal Anesthesia; Nerve Block/Methods

Keywords

Hip Fracture; Unilateral Spinal Anesthesia; Pericapsular Nerve Group Block; 3-1 Block; Suprainguinal Fascia Iliaca Compartment Block; Pain Management

Outcome Measures

Primary Outcomes (1)

• Positional Pain in Unilateral Spinal Anesthesia

  Pain in the pre-block period and during unilateral spinal anesthesia positioning after the block will be evaluated by VAS score.

  30 minutes after the block is performed

Secondary Outcomes (7)

• Position Quality in Unilateral Spinal Anesthesia

  30 minutes after the block is performed

• The Necessity for Sedoanalgesia for Positional Pain in Unilateral Spinal Anesthesia

  30 minutes after the block is performed

• Postoperative Pain

  Postoperative 2nd, 6th, 12th and 24th hours

• The Time Until First Opiod Requirement

  Postoperative first 24-hour-period

• Postoperative First 24-hour-period Total Opioid Consumption

  Postoperative first 24-hour-period

Study Arms (3)

Group 1 (PENG)

EXPERIMENTAL

A convex USG Probe (1-5 mHz) is placed transversely on the SIAS (Spina Iliaca Anterior Superior). The probe is then rotated 45 degrees and aligned with the pubic ramus. In this position, the iliopubic eminence, ilipsoas muscle-tendon, femoral artery and pectineus muscle are observed. A 100 mm 21G block needle (Stimuplex A®:B. Braun Melsungen AG, Japan) is inserted in-plane from lateral to medial to the musculofascial plane with the psoas tendon in front and the pubic ramus behind and the injection is performed.

Procedure: Pericapsular Nerve Group Block

Group 2 (S-FICB)

EXPERIMENTAL

A linear USG probe (7-13 mHz) is placed parasagittal to obtain an image of the SIAS. The probe is then shifted medially to identify the fascia iliaca, iliac muscle, internal oblique muscle and deep circumflex iliac artery. A 50 mm 21G block needle (Stimuplex A®:B. Braun Melsungen AG, Japan) is advanced in-plane from caudal to cephalic and injected between the fascia iliaca and iliac muscle.

Procedure: Suprainguinal Fascia Compartment Block

Group 3 (3-1)

EXPERIMENTAL

A linear USG probe (7-13 mHz) is placed at the level of the femoral fold and the femoral vein-arterial-nerve is visualized. The femoral nerve is located below the fascia iliaca. At this point, a 50 mm 21G block needle (Stimuplex A®:B. Braun Melsungen AG, Japan) is inserted in-plane from lateral to medial and injected lateral to the femoral nerve. After injection, pressure is applied distal to the needle entry site to spread the local anesthetic proximally in the nerve sheath.

Procedure: 3-1 Block

Interventions

Pericapsular Nerve Group Block PROCEDURE

A convex USG Probe (1-5 mHz) is placed transversely on the SIAS (Spina Iliaca Anterior Superior). The probe is then rotated 45 degrees and aligned with the pubic ramus. In this position, the iliopubic eminence, ilipsoas muscle-tendon, femoral artery and pectineus muscle are observed. A 100 mm 21G block needle (Stimuplex A®:B. Braun Melsungen AG, Japan) is inserted in-plane from lateral to medial to the musculofascial plane with the psoas tendon in front and the pubic ramus behind and the injection is performed.

Group 1 (PENG)

Suprainguinal Fascia Compartment Block PROCEDURE

A linear USG probe (7-13 mHz) is placed parasagittal to obtain an image of the SIAS. The probe is then shifted medially to identify the fascia iliaca, iliac muscle, internal oblique muscle and deep circumflex iliac artery. A 50 mm 21G block needle (Stimuplex A®:B. Braun Melsungen AG, Japan) is advanced in-plane from caudal to cephalic and injected between the fascia iliaca and iliac muscle.

Group 2 (S-FICB)

3-1 Block PROCEDURE

A linear USG probe (7-13 mHz) is placed at the level of the femoral fold and the femoral vein-arterial-nerve is visualized. The femoral nerve is located below the fascia iliaca. At this point, a 50 mm 21G block needle (Stimuplex A®:B. Braun Melsungen AG, Japan) is inserted in-plane from lateral to medial and injected lateral to the femoral nerve. After injection, pressure is applied distal to the needle entry site to spread the local anesthetic proximally in the nerve sheath.

Group 3 (3-1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and over
• American Society of Anesthesiologists Physical Status Classification(ASA) I,II and III
• Fully oriented and able to cooperate
• Consented to participate in the study by signing the informed consent form
• Patients with hip fracture and planned unilateral surgery with spinal anesthesia

You may not qualify if:

• Patients under 18 years of age
• Refusal to participate
• American Society of Anesthesiologists Physical Status Classification(ASA) IV-V
• Non-cooperation
• Coagulopathy or thrombocytopenia
• Allergic to local anesthetics and analgesics
• Patients with anatomical abnormalities or active infection at the points of application

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Izmir Bozyaka Training and Research Hospital

Izmir, Karabaglar, 35170, Turkey (Türkiye)

Location

Related Publications (3)

• Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.

  PMID: 30063657 BACKGROUND

• Hebbard P, Ivanusic J, Sha S. Ultrasound-guided supra-inguinal fascia iliaca block: a cadaveric evaluation of a novel approach. Anaesthesia. 2011 Apr;66(4):300-5. doi: 10.1111/j.1365-2044.2011.06628.x. Epub 2011 Feb 24.

  PMID: 21401544 BACKGROUND

• Winnie AP, Ramamurthy S, Durrani Z. The inguinal paravascular technic of lumbar plexus anesthesia: the "3-in-1 block". Anesth Analg. 1973 Nov-Dec;52(6):989-96. No abstract available.

  PMID: 4796576 BACKGROUND

MeSH Terms

Conditions

Hip Fractures; Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2023
• First Posted: June 22, 2023
• Study Start: January 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)