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

NCT ID: NCT06003738

Last Updated: 2023-08-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-21
• Study Completion Date: 2024-09-01

Brief Summary

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.

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

The fascia iliaca compartment block group

The first group 34 patients

Group Type: ACTIVE_COMPARATOR

fascia iliaca compartment block

Intervention Type: PROCEDURE

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.

palcebo pericapsular nerve block

Intervention Type: PROCEDURE

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 .

The pericapsular nerve block group

The second group 34 patients

Group Type: ACTIVE_COMPARATOR

pericapsular nerve block

Intervention Type: PROCEDURE

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 .

palcebo fascia iliaca compartment block

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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 .

Intervention Type: 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.

Intervention Type: 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 .

Intervention Type: PROCEDURE

Other Intervention Names

FICB; PENG; palcebo FICB; palcebo PENG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Diaaeldin Badr Aboelnile

Lecturer of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diaaeldin DA Aboelnile, MD, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Ain Shams University

Locations

Ain shams university hospitals

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Diaaeldin DA Aboelnile, MD, Lecturer

Role: CONTACT

diaabadr@gmail.com

00201018380033

Facility Contacts

Diaaeldin BM Aboelnile, MD

Role: primary

diaabadr@gmail.com

2001018380033

Other Identifiers

FMASU MD76/2023

Identifier Type: -

Identifier Source: org_study_id