Comparing Postoperative Pain After Pericapsular Nerve Block and Fascia Iliaca Block in Total Hip Arthroplasty

A Comparative Study Between the Postoperative Analgesic Effect of Pericapsular Nerve Group Block (PENG) and Fascia Iliaca Compartment Block (FICB) in Total Hip Arthroplasty: a Prospective Randomized Clinical Trial

The aim of this study is to investigate the efficiency of post-operative analgesia by fascia iliaca compartment block versus pericapsular nerve group block block in reducing narcotic consumption during the first 24 hour post-operatively by using the Visual Analogue Scale.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia
• Intervention / Treatment: Procedure: fascia iliaca compartment block; Procedure: palcebo pericapsular nerve block; Procedure: pericapsular nerve block; Procedure: palcebo fascia iliaca compartment block

Detailed Description

Total hip arthroplasty is a widely used surgical treatment intervention for treating hip conditions such as femur neck fractures and advanced hip osteoarthritis.

Hip fractures are quite common, regardless of the age of the population (young or old), and they are extremely painful. A hip fracture is a serious injury with potentially life-threatening complications, and it is a common orthopedic emergency in elderly individuals. Early surgery within 48 hours of a fracture has been found to lower mortality and complication rates.

The pericapsular nerve group block is a novel regional analgesia technique to decrease pain after THA while preserving the motor function. The local anaesthetic is deposited using this method in the fascial plane between the psoas muscle and the superior pubic ramus, which aims sensory branches of the obturator, accessory obturator, and femoral nerves in the anterior capsule of the hip.

Fascia iliaca compartment block, for procedures on the femur and hip joint, is still a well-liked regional anaesthetic technique. Studies have found that FICB prevents complications by anaesthetizing the femoral nerve far from critical neurovascular structures while still giving enough analgesia.

Both blocks could be used to effectively reduce pain intensity up to 24 hours, total opioid consumption, and length of hospital stay in THA patients.

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diaaeldin DA Aboelnile, MD, Lecturer; Phone Number: 00201018380033; Email: diaabadr@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11588
    • Recruiting
    • Ain Shams University Hospitals
    • Contact: Diaaeldin BM Aboelnile, MD; Phone Number: 2001018380033; Email: diaabadr@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-80 years.
2. Sex: Both sexes.
3. American Society of Anaesthesiologists (ASA) Physical Status Class I, II, and III.
4. Scheduled for Total hip arthroplasty (THA) under spinal anesthesia.

Exclusion Criteria:

1. Declining to give a written informed consent.
2. History of allergy to the medications used in the study.
3. Contraindications to regional anesthesia (including patient refusal, coagulopathy, and local infection).
4. Psychiatric disorders.
5. Significant cognitive dysfunction.
6. American Society of Anesthesiologists (ASA) Physical Status Class IV.
7. Liver failure, renal insufficiency (estimated glomerular filtration rate < 15 mL/min/1.73 m2).
8. Patients who had failed spinal anaesthesia were excluded from the study.
9. Pregnancy.

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
Active Comparator: The fascia iliaca compartment block group; The first group 34 patients	Procedure: fascia iliaca compartment block; Block will be performed using an ultrasound machine with a high-frequency linear probe covered with a sterile sheath and 100 mm needle. The patient will be positioned supine to perform the block, the skin is disinfected and the transducer positioned to identify the femoral artery and the iliopsoas muscle and fascia iliaca. The transducer is moved laterally until the sartorius muscle is identified. The in-plane technique will be used, and the tip of the needle will be inserted between the fascia iliaca and iliopsoas muscle. a syringe containing 15ml of 0.25% bupivacaine will be injected.; Other Names: FICB; Procedure: palcebo pericapsular nerve block; The block will be performed using the curvilinear low-frequency ultrasound probe to be placed over the line parallel to the inguinal ligament then It will be rotated 45◦ to identify the anterior inferior iliac spine, the iliopubic eminence, and the psoas tendon. A 22-gauge, 80 mm echogenic needle will be inserted in an in-plane approach to place the tip in the musculofascial plane between the pubic ramus posteriorly and the psoas tendon anteriorly a syringe containing 15ml of normal saline will be injected .; Other Names: palcebo PENG
Active Comparator: The pericapsular nerve block group; The second group 34 patients	Procedure: pericapsular nerve block; The block will be performed using the curvilinear low-frequency ultrasound probe to be placed over the line parallel to the inguinal ligament then It will be rotated 45◦ to identify the anterior inferior iliac spine, the iliopubic eminence, and the psoas tendon. A 22-gauge, 80 mm echogenic needle will be inserted in an in-plane approach to place the tip in the musculofascial plane between the pubic ramus posteriorly and the psoas tendon anteriorly a syringe containing 15ml of 0.25% bupivacaine will be injected .; Other Names: PENG; Procedure: palcebo fascia iliaca compartment block; Block will be performed using an ultrasound machine with a high-frequency linear probe covered with a sterile sheath and 100 mm needle. The patient will be positioned supine to perform the block, the skin is disinfected and the transducer positioned to identify the femoral artery and the iliopsoas muscle and fascia iliaca. The transducer is moved laterally until the sartorius muscle is identified. The in-plane technique will be used, and the tip of the needle will be inserted between the fascia iliaca and iliopsoas muscle. a syringe containing 15ml of normal saline will be injected.; Other Names: palcebo FICB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of the studied blocks on the Visual Analogue Scale for pain	the Visual Analogue Scale for pain is ranging from 0 to 10, where 0 is no pain and 10 is maximum pain	Immediately postoperatively (zero time)
Change in the Visual Analogue Scale for pain	the Visual Analogue Scale for pain is ranging from 0 to 10, where 0 is no pain and 10 is maximum pain	Every 2 hours during the first 6 hours
Change in the Visual Analogue Scale for pain	the Visual Analogue Scale for pain is ranging from 0 to 10, where 0 is no pain and 10 is maximum pain	every 6 hours in the first 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total dose of nalbuphine in mg was used postoperatively per patient	rescue analgesia	24 hours postoperatively
Mean arterial blood pressure change	hemodynamics	24 hours postoperatively
Heart rate change	hemodynamics	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Diaaeldin DA Aboelnile, MD, Lecturer, Faculty of Medicine, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2023
• Primary Completion (Estimated): August 21, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: FMASU MD76/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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