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

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ClinicalTrials.gov Identifier: NCT04981236
Recruitment Status : Recruiting
First Posted : July 28, 2021
Last Update Posted : August 30, 2021
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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
Total Hip Arthroplasty Postoperative Pain Procedure: Pericapsular nerve group block Procedure: Periarticular block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 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 : August 17, 2021
Estimated Primary Completion Date : June 23, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Numeric rating scale pain score [ Time Frame: up to 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) 1, 6, 24, and 48 hours after the surgery.


Secondary Outcome Measures :
  1. Quadriceps muscle strength [ Time Frame: up to 24 hours postoperatively ]
    Quadriceps muscle strength will be measured by the dynamometer before the surgery and at 6, and 24 hours postoperatively (both legs)



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04981236


Contacts
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Contact: Yong Seon Choi 82-2-2224-3919 yschoi@yuhs.ac

Locations
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Korea, Republic of
Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea Recruiting
Seoul, Korea, Republic of
Contact: Yong Seon Choi    82-2-2224-3919    yschoi@yuhs.ac   
Sponsors and Collaborators
Yonsei University
Investigators
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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
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT04981236    
Other Study ID Numbers: 4-2021-0725
First Posted: July 28, 2021    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations