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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06003738
• Other study ID #: FMASU MD76/2023
• Status: Recruiting
• Phase: N/A
• Start date: August 21, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: August 2023
• Source: Ain Shams University
• Contact: Diaaeldin DA Aboelnile, MD, Lecturer
• Phone: 00201018380033
• Email: diaabadr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: September 1, 2024
• Est. primary completion date: August 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

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.
• 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 .
• 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.
• 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 .

Locations

Country	Name	City	State
Egypt	Ain shams university hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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	The total dose of nalbuphine in mg was used postoperatively per patient	rescue analgesia	24 hours postoperatively
Secondary	Mean arterial blood pressure change	hemodynamics	24 hours postoperatively
Secondary	Heart rate change	hemodynamics	24 hours postoperatively