Pericapsular Nerve Group (PENG) Block Versus Periarticular Injection for Pain Management After Total Hip Arthroplasty
Primary Purpose
Total Hip Arthroplasty, Postoperative Pain
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pericapsular nerve group block
Periarticular block
Sponsored by
About this trial
This is an interventional supportive care trial for Total Hip Arthroplasty
Eligibility Criteria
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
Sites / Locations
- Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine, Seoul, South KoreaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Pericapsular nerve group block
Periarticular block
Arm Description
Participants receiving pericapsular nerve group block
Participants receiving periarticular block
Outcomes
Primary Outcome Measures
Numeric rating scale pain score
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
Numeric rating scale pain score
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
Quadriceps muscle strength
Quadriceps muscle strength will be measured by the dynamometer at 24h postoperatively
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04981236
Brief Title
Pericapsular Nerve Group (PENG) Block Versus Periarticular Injection for Pain Management After Total Hip Arthroplasty
Official Title
Pericapsular Nerve Group (PENG) Block Versus Periarticular Injection for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2021 (Actual)
Primary Completion Date
June 23, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Hip Arthroplasty, Postoperative Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pericapsular nerve group block
Arm Type
Active Comparator
Arm Description
Participants receiving pericapsular nerve group block
Arm Title
Periarticular block
Arm Type
Experimental
Arm Description
Participants receiving periarticular block
Intervention Type
Procedure
Intervention Name(s)
Pericapsular nerve group block
Other Intervention Name(s)
PENG block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Periarticular block
Intervention Description
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 Measure Information:
Title
Numeric rating scale pain score
Description
Pain intensity at rest evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) at 24 hours postoperatively
Time Frame
at 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Numeric rating scale pain score
Description
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
Time Frame
at 6 hours postoperatively and 48h postoperatively
Title
Quadriceps muscle strength
Description
Quadriceps muscle strength will be measured by the dynamometer at 24h postoperatively
Time Frame
at 24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Seon Choi
Phone
82-2-2224-3919
Email
yschoi@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Seon Choi
Organizational Affiliation
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Seon Choi
Phone
82-2-2224-3919
Email
yschoi@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
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Pericapsular Nerve Group (PENG) Block Versus Periarticular Injection for Pain Management After Total Hip Arthroplasty
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