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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05427019
Other study ID # 4-2022-0508
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 17, 2022
Est. completion date May 2024

Study information

Verified date January 2024
Source Yonsei University
Contact Yong Seon Choi
Phone 82-2-2224-3919
Email yschoi@yuhs.ac
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Continuous administration of local anesthetics to the distal adductor canal could spread into the popliteal fossa and contribute to analgesic effects on posterior knee pain. Periarticular local anesthetic infiltration is a component of multimodal joint pathways and the posterior knee capsule was among the tissues routinely infiltrated. It is expected that there will be overlapping effects of distal adductor canal block and periarticular injection. Therefore, we aim to compare the postoperative pain in the group that received only continuous distal adductor canal block and the group that received both continuous distal adductor canal block and periarticular injection. Sixty-six patients scheduled for total knee arthroplasty will be randomly divided into the two groups. In group 1, the adductor canal catheter is inserted 2cm above the adductor hiatus. In group 2, the adductor canal catheter is inserted where the nerve block performed in group 1 and periarticular injection are performed intraoperatively.


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: 1. Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective unilateral total knee 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


Related Conditions & MeSH terms


Intervention

Procedure:
Distal adductor canal block
All catheters were inserted under a full aseptic technique using a real-time ultrasound-guided in-plane approach by an experienced anesthesiologist. The adductor canal catheter is inserted 2cm above the adductor hiatus.
Distal adductor canal block and Periarticular block
All catheters were inserted under a full aseptic technique using a real-time ultrasound-guided in-plane approach by an experienced anesthesiologist. The adductor canal catheter is inserted 2cm above the adductor hiatus.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 Yonsei University Health System, Severance Hospital 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) postoperative 1 day morning (08:00-09:00 AM)
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) postoperative 6 hours, postoperative 1 day afternoon (4:00-5:00 PM), postoperative 2 day morning (08:00-09:00 AM)
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