- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04981236
Pericapsular Nerve Group (PENG) Block Versus Periarticular Injection for Pain Management After Total Hip Arthroplasty
February 13, 2024 updated by: Yonsei University
Pericapsular Nerve Group (PENG) Block Versus Periarticular Injection for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, 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
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Aged 19 years old or older
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Pericapsular nerve group block
Participants receiving 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:
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Experimental: Periarticular block
Participants receiving periarticular block
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Numeric rating scale pain score
Time Frame: at 24 hours postoperatively
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Pain intensity at rest evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) at 24 hours postoperatively
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at 24 hours postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Numeric rating scale pain score
Time Frame: at 6 hours postoperatively and 48h postoperatively
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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
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at 6 hours postoperatively and 48h postoperatively
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Quadriceps muscle strength
Time Frame: at 24 hours postoperatively
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Quadriceps muscle strength will be measured by the dynamometer at 24h postoperatively
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at 24 hours postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 17, 2021
Primary Completion (Actual)
May 26, 2023
Study Completion (Actual)
May 26, 2023
Study Registration Dates
First Submitted
July 22, 2021
First Submitted That Met QC Criteria
July 22, 2021
First Posted (Actual)
July 28, 2021
Study Record Updates
Last Update Posted (Actual)
February 15, 2024
Last Update Submitted That Met QC Criteria
February 13, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2021-0725
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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