- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05427019
Continuous Distal Adductor Canal Block With Periarticular Local Anesthetic Infiltration Versus Continuous Distal Adductor Canal Block Alone for Analgesia After Total Knee Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yong Seon Choi
- Phone Number: 82-2-2224-3919
- Email: yschoi@yuhs.ac
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- Yonsei University Health System, Severance Hospital
-
Contact:
- Yong Seon Choi
- Phone Number: 82-2-2224-3919
- Email: yschoi@yuhs.ac
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Distal adductor canal block
Participants receiving continuous 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.
|
|
Active Comparator: Distal adductor canal block and Periarticular block
Participants receiving continuous 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric rating scale pain score
Time Frame: postoperative 1 day morning (08:00-09:00 AM)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric rating scale pain score
Time Frame: postoperative 6 hours, postoperative 1 day afternoon (4:00-5:00 PM), postoperative 2 day morning (08:00-09:00 AM)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yong Seon Choi, Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2022-0508
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Degenerative Osteoarthritis
-
Lovisenberg Diakonale HospitalVestre Viken Hospital Trust; Haukeland University HospitalActive, not recruitingDegenerative Joint Disease of Knee | Osteoarthritis; PrimaryNorway
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingOpen Fractures, Degenerative Osteoarthritis and Degenerative Spinal Diseases
-
University Hospital, BordeauxBiom'Up France SASCompletedDegenerative Osteoarthritis | Degenerative Lumbar VertebraFrance
-
Kolon TissueGene, Inc.Not yet recruitingDegenerative Osteoarthritis
-
Kolon TissueGene, Inc.CompletedDegenerative OsteoarthritisUnited States
-
Kolon TissueGene, Inc.Active, not recruitingDegenerative OsteoarthritisUnited States
-
Singapore General HospitalRecruitingKnee Osteoarthritis | Degenerative Joint Disease of the KneeSingapore
-
Smith & Nephew Orthopaedics AGIQVIA Pty Ltd; eResearchTechnology, Inc; M Squared Associates,Inc.; ExecuPharm...CompletedDegenerative Joint Disease of HipBelgium, Finland, Spain, United Kingdom
-
Feza Korkusuz MDDr. Özgür Oktay Nar Private Clinic, Bursa, Türkiye; Contura International A... and other collaboratorsCompletedOsteoarthritis | Knee Osteoarthritis | Osteoarthritis of the Knee | Degenerative Joint Disease of the KneeTurkey (Türkiye)
-
Kayseri City HospitalCompletedOsteoarthritis of Knee | Degenerative OsteoarthritisTurkey
Clinical Trials on Distal adductor canal block
-
Benaroya Research InstituteCompletedPost-Operative PainUnited States
-
Ankara Etlik City HospitalActive, not recruitingPostoperative Pain | Total Knee AnthroplastyTurkey (Türkiye)
-
Konya Beyhekim Training and Research HospitalNot yet recruitingTotal Knee Arthroplasty | Adductor Canal Block | IPACK Block Multimodal Analgesia | Genicular Nerves Block
-
Yonsei UniversityNot yet recruitingPostoperative Pain | Knee Osteoarthritis | Total Knee Arthroplasty | Peripheral Nerve Block | Adductor Canal Block
-
Karaman Training and Research HospitalCompletedOsteo Arthritis KneeTurkey
-
Fayoum University HospitalNot yet recruiting
-
Ain Shams UniversityNot yet recruitingFunctional Recovery | Adductor Canal Block | Total Knee Replacement Surgery
-
Lawson Health Research InstituteCompleted
-
TC Erciyes UniversityRecruitingKnee Arthroplasty, TotalTurkey (Türkiye)
-
Ankara Etlik City HospitalEnrolling by invitationTotal Knee Arthroplasty for GonarthrosisTurkey (Türkiye)