Pericapsular Nerve Group (PENG) Block Versus Supra-inguinal Fascia Iliaca Compartment Block for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT04426045
Collaborator
(none)
58
1
2
10.6
5.4

Study Details

Study Description

Brief Summary

Adequate pain control after total hip arthroplasty is crucial for early ambulation and patient satisfaction. The supra-inguinal fascia iliaca compartment block has been described as a promising technique for primary total hip arthroplasty. However, one of the concerns with supra-inguinal fascia iliaca compartment block is still the potential for quadriceps weakness that might delay ambulation. The pericapsular nerve group (PENG) block has been recently introduced a new technique for blockade of the articular branches of the femoral, obturator and accessory obturator nerves. PENG block is possible to provide sufficient analgesia and preserve lower limb muscle strength. The investigators will compare ultrasound-guided supra-inguinal fascia iliaca compartment block with PENG block in patients undergoing total hip arthroplasty.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pericapsular nerve group block
  • Procedure: Supra-inguinal fascia iliaca compartment block
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Pericapsular Nerve Group (PENG) Block Versus Supra-inguinal Fascia Iliaca Compartment Block for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial
Actual Study Start Date :
Jul 21, 2020
Actual Primary Completion Date :
Jun 6, 2021
Actual Study Completion Date :
Jun 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pericapsular nerve group block

Participants receiving pericapsular nerve group block

Procedure: Pericapsular nerve group block
A curvilinear 2-5MHz ultrasound probe will be initially placed in a transverse plane over the anterior superior iliac spine and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the iliopubic eminence, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be observed. A 22-gauge, 80-mm needle will be inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. A total volume of 20 ml of ropivacaine 0.2% will be injected.
Other Names:
  • PENG block
  • Active Comparator: Supra-inguinal fascia iliaca compartment block

    Participants receiving supra-inguinal fascia iliaca compartment block

    Procedure: Supra-inguinal fascia iliaca compartment block
    A linear 6-13-MHz ultrasound probe will be placed in the sagittal plane to obtain an image of the anterior superior iliac spine. The fascia iliaca and sartorius, iliopsoas, and oblique internal muscles will be identified by sliding the probe medially. After identifying the "bow-tie sign" formed by the muscle fascias, a 22-gauge, 80-mm needle will be introduced 1 cm cephalad to the inguinal ligament. Using an in-plane approach, the fascia iliaca will be penetrated and hydrodissected, separating the fascia iliaca from the iliac muscle. A total volume of 30 ml of ropivacaine 0.2% will be injected.
    Other Names:
  • Supra-inguinal FICB
  • Outcome Measures

    Primary Outcome Measures

    1. Numeric rating scale pain score [1 hour after the surgery]

      Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)

    2. Numeric rating scale pain score [6 hours after the surgery]

      Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)

    3. Numeric rating scale pain score [24 hours after the surgery]

      Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)

    4. Numeric rating scale pain score [36 hours after the surgery]

      Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)

    5. Numeric rating scale pain score [48 hours after the surgery]

      Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)

    Secondary Outcome Measures

    1. Quadriceps muscle strength [baseline]

      Quadriceps muscle strength will be measured by the dynamometer

    2. Quadriceps muscle strength [at 6 hours postoperatively]

      Quadriceps muscle strength will be measured by the dynamometer

    3. Quadriceps muscle strength [at 24 hours postoperatively]

      Quadriceps muscle strength will be measured by the dynamometer

    4. Quadriceps muscle strength [at 36 hours postoperatively]

      Quadriceps muscle strength will be measured by the dynamometer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3

    • scheduled for elective unilateral total hip arthroplasty

    Exclusion Criteria:
    • Allergy or intolerance to any of the drugs used in the study

    • Hepatic or renal insufficiency

    • Opioid dependency

    • Coagulopathy

    • Pre-existing neurologic or anatomic deficits in the lower extremities

    • Severe psychiatric illness

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anesthesia and Pain Research Institute, Yonsei University College of Medicine Seoul Korea, Republic of

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT04426045
    Other Study ID Numbers:
    • 4-2020-0417
    First Posted:
    Jun 11, 2020
    Last Update Posted:
    Jul 20, 2021
    Last Verified:
    Jul 1, 2021
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 20, 2021