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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04426045
Other study ID # 4-2020-0417
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 21, 2020
Est. completion date June 10, 2021

Study information

Verified date July 2021
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date June 10, 2021
Est. primary completion date June 6, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design


Intervention

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 0.2% will be injected.
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.

Locations

Country Name City State
Korea, Republic of Anesthesia and Pain Research Institute, Yonsei University College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 1 hour after the surgery
Primary 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) 6 hours after the surgery
Primary 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) 24 hours after the surgery
Primary 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) 36 hours after the surgery
Primary 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) 48 hours after the surgery
Secondary Quadriceps muscle strength Quadriceps muscle strength will be measured by the dynamometer baseline
Secondary Quadriceps muscle strength Quadriceps muscle strength will be measured by the dynamometer at 6 hours postoperatively
Secondary Quadriceps muscle strength Quadriceps muscle strength will be measured by the dynamometer at 24 hours postoperatively
Secondary Quadriceps muscle strength Quadriceps muscle strength will be measured by the dynamometer at 36 hours postoperatively
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