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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04981236
Other study ID # 4-2021-0725
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 17, 2021
Est. completion date May 26, 2023

Study information

Verified date February 2024
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 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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date May 26, 2023
Est. primary completion date May 26, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: 1. Aged 19 years old or older 2. American Society of Anesthesiologists Physical Status 1-3 3. Scheduled for elective unilateral total hip arthroplasty Exclusion Criteria: 1. Allergy or intolerance to any of the drugs used in the study 2. Hepatic or renal insufficiency 3. Opioid dependency 4. Coagulopathy 5. Pre-existing neurologic or anatomic deficits in the lower extremities 6. 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 0.3% will be injected.
Periarticular block
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.

Locations

Country Name City State
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 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 evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) at 24 hours postoperatively at 24 hours postoperatively
Secondary 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 at 6 hours postoperatively and 48h postoperatively
Secondary Quadriceps muscle strength Quadriceps muscle strength will be measured by the dynamometer at 24h postoperatively at 24 hours postoperatively
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