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

NCT06003738 | Unknown

• 1 other identifier: FMASU MD76/2023
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• The total dose of nalbuphine in mg was used postoperatively per patient

  24 hours postoperatively

• Mean arterial blood pressure change

  24 hours postoperatively

• Heart rate change

  24 hours postoperatively

Study Arms (2)

The fascia iliaca compartment block group

ACTIVE COMPARATOR

The first group 34 patients

Procedure: fascia iliaca compartment block; Procedure: palcebo pericapsular nerve block

The pericapsular nerve block group

ACTIVE COMPARATOR

The second group 34 patients

Procedure: pericapsular nerve block; Procedure: palcebo fascia iliaca compartment block

Interventions

fascia iliaca compartment block 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.

Also known as: FICB

The fascia iliaca compartment block group

pericapsular nerve block 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 .

Also known as: PENG

The pericapsular nerve block group

palcebo fascia iliaca compartment block 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.

Also known as: palcebo FICB

The pericapsular nerve block group

palcebo pericapsular nerve block 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 .

Also known as: palcebo PENG

The fascia iliaca compartment block group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university hospitals

Cairo, 11588, Egypt

RECRUITING

Study Officials

• Diaaeldin DA Aboelnile, MD, Lecturer

  Faculty of Medicine, Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diaaeldin DA Aboelnile, MD, Lecturer

CONTACT

00201018380033; diaabadr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 22, 2023
• Study Start: August 21, 2023
• Primary Completion: August 21, 2024
• Study Completion: September 1, 2024
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)