- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04426045
Pericapsular Nerve Group (PENG) Block Versus Supra-inguinal Fascia Iliaca Compartment Block for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial
July 19, 2021 updated by: Yonsei University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
58
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
-
-
-
Seoul, Korea, Republic of
- Anesthesia and Pain Research Institute, Yonsei University College of Medicine
-
-
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
Genders Eligible for Study
All
Description
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
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 |
|---|---|
|
Experimental: 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 0.2% will be injected.
Other Names:
|
|
Active Comparator: Supra-inguinal fascia iliaca compartment block
Participants receiving supra-inguinal fascia iliaca compartment block
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric rating scale pain score
Time Frame: 1 hour 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 hour after the surgery
|
|
Numeric rating scale pain score
Time Frame: 6 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)
|
6 hours after the surgery
|
|
Numeric rating scale pain score
Time Frame: 24 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)
|
24 hours after the surgery
|
|
Numeric rating scale pain score
Time Frame: 36 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)
|
36 hours after the surgery
|
|
Numeric rating scale pain score
Time Frame: 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)
|
48 hours after the surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quadriceps muscle strength
Time Frame: baseline
|
Quadriceps muscle strength will be measured by the dynamometer
|
baseline
|
|
Quadriceps muscle strength
Time Frame: at 6 hours postoperatively
|
Quadriceps muscle strength will be measured by the dynamometer
|
at 6 hours postoperatively
|
|
Quadriceps muscle strength
Time Frame: at 24 hours postoperatively
|
Quadriceps muscle strength will be measured by the dynamometer
|
at 24 hours postoperatively
|
|
Quadriceps muscle strength
Time Frame: at 36 hours postoperatively
|
Quadriceps muscle strength will be measured by the dynamometer
|
at 36 hours postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
July 21, 2020
Primary Completion (Actual)
June 6, 2021
Study Completion (Actual)
June 10, 2021
Study Registration Dates
First Submitted
June 8, 2020
First Submitted That Met QC Criteria
June 9, 2020
First Posted (Actual)
June 11, 2020
Study Record Updates
Last Update Posted (Actual)
July 20, 2021
Last Update Submitted That Met QC Criteria
July 19, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2020-0417
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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