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

Sponsor
Ain Shams University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06003738
Collaborator
(none)
68
1
2
12.4
5.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: fascia iliaca compartment block
  • Procedure: pericapsular nerve block
  • Procedure: palcebo fascia iliaca compartment block
  • Procedure: palcebo pericapsular nerve block
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 21, 2023
Anticipated Primary Completion Date :
Aug 21, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. The effect of the studied blocks on the Visual Analogue Scale for pain [Immediately postoperatively (zero time)]

      the Visual Analogue Scale for pain is ranging from 0 to 10, where 0 is no pain and 10 is maximum pain

    2. Change in the Visual Analogue Scale for pain [Every 2 hours during the first 6 hours]

      the Visual Analogue Scale for pain is ranging from 0 to 10, where 0 is no pain and 10 is maximum pain

    3. Change in the Visual Analogue Scale for pain [every 6 hours in the first 24 hours postoperatively]

      the Visual Analogue Scale for pain is ranging from 0 to 10, where 0 is no pain and 10 is maximum pain

    Secondary Outcome Measures

    1. The total dose of nalbuphine in mg was used postoperatively per patient [24 hours postoperatively]

      rescue analgesia

    2. Mean arterial blood pressure change [24 hours postoperatively]

      hemodynamics

    3. Heart rate change [24 hours postoperatively]

      hemodynamics

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ain shams university hospitals Cairo Egypt 11588

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Diaaeldin Badr Aboelnile, Lecturer of Anesthesia, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT06003738
    Other Study ID Numbers:
    • FMASU MD76/2023
    First Posted:
    Aug 22, 2023
    Last Update Posted:
    Aug 23, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 23, 2023