Pericapsular Nerve Group (PENG) Block Versus Supra-inguinal Fascia Iliaca Compartment Block for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial
Primary Purpose
Total Hip Arthroplasty, Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pericapsular nerve group block
Supra-inguinal fascia iliaca compartment block
Sponsored by
About this trial
This is an interventional supportive care trial for Total Hip Arthroplasty
Eligibility Criteria
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
Sites / Locations
- Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pericapsular nerve group block
Supra-inguinal fascia iliaca compartment block
Arm Description
Participants receiving pericapsular nerve group block
Participants receiving supra-inguinal fascia iliaca compartment block
Outcomes
Primary Outcome Measures
Numeric rating scale pain score
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)
Numeric rating scale pain score
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)
Numeric rating scale pain score
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)
Numeric rating scale pain score
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)
Numeric rating scale pain score
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
Quadriceps muscle strength
Quadriceps muscle strength will be measured by the dynamometer
Quadriceps muscle strength
Quadriceps muscle strength will be measured by the dynamometer
Quadriceps muscle strength
Quadriceps muscle strength will be measured by the dynamometer
Quadriceps muscle strength
Quadriceps muscle strength will be measured by the dynamometer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04426045
Brief Title
Pericapsular Nerve Group (PENG) Block Versus Supra-inguinal Fascia Iliaca Compartment Block for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
June 6, 2021 (Actual)
Study Completion Date
June 10, 2021 (Actual)
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 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.
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
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pericapsular nerve group block
Arm Type
Experimental
Arm Description
Participants receiving pericapsular nerve group block
Arm Title
Supra-inguinal fascia iliaca compartment block
Arm Type
Active Comparator
Arm Description
Participants receiving supra-inguinal fascia iliaca compartment 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 0.2% will be injected.
Intervention Type
Procedure
Intervention Name(s)
Supra-inguinal fascia iliaca compartment block
Other Intervention Name(s)
Supra-inguinal FICB
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric rating scale pain score
Description
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)
Time Frame
1 hour after the surgery
Title
Numeric rating scale pain score
Description
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)
Time Frame
6 hours after the surgery
Title
Numeric rating scale pain score
Description
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)
Time Frame
24 hours after the surgery
Title
Numeric rating scale pain score
Description
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)
Time Frame
36 hours after the surgery
Title
Numeric rating scale pain score
Description
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)
Time Frame
48 hours after the surgery
Secondary Outcome Measure Information:
Title
Quadriceps muscle strength
Description
Quadriceps muscle strength will be measured by the dynamometer
Time Frame
baseline
Title
Quadriceps muscle strength
Description
Quadriceps muscle strength will be measured by the dynamometer
Time Frame
at 6 hours postoperatively
Title
Quadriceps muscle strength
Description
Quadriceps muscle strength will be measured by the dynamometer
Time Frame
at 24 hours postoperatively
Title
Quadriceps muscle strength
Description
Quadriceps muscle strength will be measured by the dynamometer
Time Frame
at 36 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Anesthesia and Pain Research Institute, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pericapsular Nerve Group (PENG) Block Versus Supra-inguinal Fascia Iliaca Compartment Block for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial
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