Peri-capsular Nerve Group Block Versus Fascia Iliaca Block for Hip Arthroplasty

Pericapsular Nerve Group Block Versus Fascia Iliaca Block for Hip Arthroplasty: a Randomized Controlled Trial

In this study, the investigator will examine the efficacy of Pericapsular nerve group (PENG) block in hip surgeries as a post-operative pain management technique in comparison with fascia Iliaca block in hip surgeries

Study Overview

• Status: Unknown
• Conditions: Post Operative Pain Management
• Intervention / Treatment: Procedure: Fascia Iliaca BLock; Procedure: Pericapsular nerve group block

Detailed Description

Hip fracture is a common orthopedic emergency in the elderly, and it is associated with significant morbidity and mortality.1 Surgical reduction and fixation are the definitive treatment in most patients.2 Effective perioperative analgesia that minimizes the need for opioids and related adverse effects (such as delirium) is essential in this patient population.

Regional analgesic techniques, including femoral nerve (FN) block, fascia iliaca block (FIB), and 3-in-1 FN block, are popular analgesic strategies, due mainly to their opioid-sparing effects and reduction in opioid-related adverse effects. The effect size of analgesia from these blocks is only moderate, and literature suggests that the obturator nerve (ON) is not covered.

The anterior hip capsule is innervated by the ON, accessory obturator nerve (AON), and FN as reported by previous anatomic studies. The anterior capsule is the most richly innervated section of the joint, suggesting these nerves should be the main targets for hip analgesia. A recent anatomical study by Short et al15 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. This study also identified the relevant landmarks for those articular branches. The high articular branches from FN and AON are consistently found between the anterior inferior iliac spines (AIIS) and the iliopubic eminence (IPE), whereas the ON , close to the inferomedial acetabulum. Using this information, the investigator developed an ultrasound-guided technique for blockade of these articular branches to the hip, the PENG (PEricapsular Nerve Group) block. In this study, the investigator will examine the efficacy of PENG block in hip surgeries as a post-operative pain management technique in comparison with fascia Iliaca block in hip surgeries

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 1234
      • Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled for hip replacement surgeries e.g. hip hemiarthroplasty, total hip arthroplasty under subarachnoid block (SAB)

Exclusion Criteria:

• Coagulopathy
• infection at the injection site
• allergy to local anesthetics
• severe cardiopulmonary disease (≥ASA IV)
• diabetic or other neuropathies
• patients receiving opioids for chronic analgesic therapy
• contraindication to spinal anesthesia
• inability to comprehend visual analog scale (VAS).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FIB; hip fracture with fascia Iliaca block	Procedure: Fascia Iliaca BLock; In supine position, a high frequency linear probe will be placed in the inguinal crease. Scan starting laterally from the femoral artery and nerve in inguinal crease to identify the sartorius muscle, tracing the muscle until it's origin to anterior superior iliac spine. The shadow of the bony of iliac crest & iliacus muscle will be seen, the end point of the injection is deep to the fascia iliaca and above the iliacus muscle in the lateral part of the iliacus muscle. After negative aspiration, 30 mL of 0.25 % of bupivacaine will be injected under the fascial plane incrementally, aspirating every 5 ml.; Other Names: FIB
Experimental: PENG; Hip fracture with Pericapsular nerve group block	Procedure: Pericapsular nerve group block; The regional block was performed with the patient in the supine position. A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees (Figs. 2, 3). In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 80-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic solution (20ml of bupivacaine 0.25%) was injected in 5-mL increments while observing for adequate fluid spread in this plane for a total volume of 30 mL; Other Names: PENG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
morphine consumption	total morphine consumption over 24 hours	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain scale Visual analogue Scale	Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.	24hours
muscle power	Assessment of quadriceps femoris muscle strength: For motor block assessment, the patient will be in supine position and the patient's knee will be fully flexed, and the patient will be asked to extend it. The motor block is classified as follows: grade 0; normal muscle power, grade I; motor weakness, grade II; complete motor paralysis	24 HOURS

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 15, 2019
• Primary Completion (Anticipated): May 31, 2019
• Study Completion (Anticipated): June 20, 2019

Study Registration Dates

• First Submitted: December 18, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (Actual): December 21, 2018

Study Record Updates

• Last Update Posted (Actual): December 21, 2018
• Last Update Submitted That Met QC Criteria: December 19, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Swelam PENG block

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No