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Pericapsular Nerve Group (PENG) Block Versus Periarticular Injection for Pain Management After Total Hip Arthroplasty

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04981236
Collaborator
(none)
66
Enrollment
1
Location
2
Arms
22.4
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Adequate pain control after total hip arthroplasty is crucial for early ambulation and patient satisfaction. 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 provides sufficient analgesia but it is still the potential for quadriceps weakness that might delay ambulation. Periarticular injection has attached attention as an effective analgesic modality with a low prevalence of adverse effects. The investigators will compare ultrasound-guided PENG block with periarticular injection in patients undergoing total hip arthroplasty.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pericapsular nerve group block
  • Procedure: Periarticular block
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Pericapsular Nerve Group (PENG) Block Versus Periarticular Injection for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial
Actual Study Start Date :
Aug 17, 2021
Anticipated Primary Completion Date :
Jun 23, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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 0.3% will be injected.
Other Names:
  • PENG block

    		•
    Experimental: Periarticular block

    Participants receiving periarticular block

    Procedure: Periarticular block
    The periarticular injection solution contained 20mL of 7.5 mg/mL ropivacaine, 30mg of ketorolac, and 0.3mL of 1.0 mg/mL epinephrine. These agents were mixed with normal saline to a combined volume of 50mL. The surgeon injected this mixture into the tensor fascia lata, subcutaneous tissues, abductors, short external rotators muscles, and structures in the capsule.

    Outcome Measures

    Primary Outcome Measures

    1. Numeric rating scale pain score [at 24 hours postoperatively]

      Pain intensity at rest evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) at 24 hours postoperatively

    Secondary Outcome Measures

    1. Numeric rating scale pain score [at 6 hours postoperatively and 48h postoperatively]

      Pain intensity at rest evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) at 6 hours postoperatively and 48h postoperatively

    2. Quadriceps muscle strength [at 24 hours postoperatively]

      Quadriceps muscle strength will be measured by the dynamometer at 24h postoperatively

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Aged 19 years old or older

    2. American Society of Anesthesiologists Physical Status 1-3

    3. Scheduled for elective unilateral total hip arthroplasty

    Exclusion Criteria:

    1. Allergy or intolerance to any of the drugs used in the study

    2. Hepatic or renal insufficiency

    3. Opioid dependency

    4. Coagulopathy

    5. Pre-existing neurologic or anatomic deficits in the lower extremities

    6. Severe psychiatric illness

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea Seoul Korea, Republic of

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    • Principal Investigator: Yong Seon Choi, Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT04981236
    Other Study ID Numbers:
    • 4-2021-0725
    First Posted:
    Jul 28, 2021
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Apr 1, 2022
    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:
    Pain, Postoperative

    Study Results

    No Results Posted as of Apr 5, 2022