- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06084403
Ultrasound-Guided Adductor Canal Block for Total Knee Arthroplasty Surgery
The Efficacy of Different Volumes for Ultrasound-Guided Adductor Canal Block for Postoperative Analgesia Management After Total Knee Arthroplasty Surgery
Study Overview
Status
Detailed Description
Knee arthroplasty is one of the most common orthopedic procedures. Patients may complain severe pain due to the surgical trauma and the prosthesis. Opioid agents are commonly used for analgesia management. However, opioids have adverse effects such as nausea, vomiting, sedation and respiratory depression. Peripheral nerve blocks such as femoral block, adductor canal block (ACB) may be performed to reduce opioid consumption and opioid-related side effects.
Selective blockade of the saphenous nerve in the adductor canal for knee surgery provides effective analgesia without quadriceps muscle weakness. This is an important advantage of ACB since it there is no motor blockade in the postoperative period. Blocking of the motor branches leads to delaying of the mobilization and it increases the patient's falling risk. ACB, targets the saphenous nerve and the vastus medialis branch which are the two largest sensorial nerves of the femoral nerve that innervates the knee. ACB blocks the articular branches of the obturator nerve at the same time. Since the ACB is performed at the distal site of thigh it does not target majority of the efferent branches of the quadriceps muscle, therefore the strength of this muscle may not be affected. ACB is usually performed with a volume of 10-30 ml and studies may be needed including different volumes to understand its effectiveness.
The aim of this study is to compare the different volumes (20 ml, 30 ml, and 40 ml) of US-guided ACB for postoperative analgesia management after total knee arthroplasty. The primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), motor blockage, the first mobilization time, and adverse effects related with opioids (allergic reaction, nausea, vomiting).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: MÜRSEL EKİNCİ
- Phone Number: +905067137596
- Email: drmurselekinci@gmail.com
Study Contact Backup
- Name: Ahmet Kaciroglu
- Email: akaciroglu@gmail.com
Study Locations
-
-
-
Bursa, Turkey
- Recruiting
- Mürsel Ekinci
-
Contact:
- MÜRSEL EKİNCİ
- Phone Number: 05067137596
- Email: drmurselekinci@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) classification I-II-III
- Scheduled for total knee arthroplasty under spinal anesthesia
Exclusion Criteria:
- history of bleeding diathesis
- receiving anticoagulant treatment,
- known local anesthetics and opioid allergy,
- infection of the skin at the site of the needle puncture,
- pregnancy or lactation,
- patients who do not accept the procedur
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 20 ml volume adductor canal block
ACB will be performed at the end of the surgery.
Patients will be administered tenoxicam (Tilcotil 20 mg flakon) 20 mg IV every 12 hours in the postoperative period.
A patient controlled device prepared with 5 mg/ ml tramadol (100 mg-Contramal ® ampul) will be attached to all patients with a protocol included 10 mg bolus without infusion dose, 20 min lockout time and 4 hour limit.
If the VAS score will be ≥ 4, 0,5 mg/kg-1 meperidine (Aldolan ampul 100 mg/2 ml) IV will be administered.
|
ACB will be performed at the end of the surgery.
After identifying the adductor canal, by using the in-plane technique, the probe will be placed at the mid-thigh, half the distance between the inguinal crease and the patella, for block location.
The superficial femoral artery will be visualized dorsal to the sartorius muscle.
Then, the probe will be removed to distally.
At this level, the hyperechoic view of the saphenous nerve will be visualized lateral and anterior to the artery in the subsartorial region.
5 mL of saline will be injected to confirm the proper injection site, and then a dose of 0.25% bupivacaine (Buvasin %5 flakon) 20ml will be injected here.
|
Active Comparator: 30 ml volume adductor canal block
ACB will be performed at the end of the surgery.
Patients will be administered tenoxicam (Tilcotil 20 mg flakon) 20 mg IV every 12 hours in the postoperative period.
A patient controlled device prepared with 5 mg/ ml tramadol (100 mg-Contramal ® ampul) will be attached to all patients with a protocol included 10 mg bolus without infusion dose, 20 min lockout time and 4 hour limit.
If the VAS score will be ≥ 4, 0,5 mg/kg-1 meperidine (Aldolan ampul 100 mg/2 ml) IV will be administered.
|
ACB will be performed at the end of the surgery.
After identifying the adductor canal, by using the in-plane technique, the probe will be placed at the mid-thigh, half the distance between the inguinal crease and the patella, for block location.
The superficial femoral artery will be visualized dorsal to the sartorius muscle.
Then, the probe will be removed to distally.
At this level, the hyperechoic view of the saphenous nerve will be visualized lateral and anterior to the artery in the subsartorial region.
5 mL of saline will be injected to confirm the proper injection site, and then a dose of 0.25% bupivacaine(Buvasin %5 flakon) 30ml will be injected here.
|
Active Comparator: 40 ml volume adductor canal block
ACB will be performed at the end of the surgery.
Patients will be administered tenoxicam (Tilcotil 20 mg flakon) 20 mg IV every 12 hours in the postoperative period.
A patient controlled device prepared with 5 mg/ ml tramadol (100 mg-Contramal ® ampul) will be attached to all patients with a protocol included 10 mg bolus without infusion dose, 20 min lockout time and 4 hour limit.
If the VAS score will be ≥ 4, 0,5 mg/kg-1 meperidine (Aldolan ampul 100 mg/2 ml) IV will be administered.
|
ACB will be performed at the end of the surgery.
After identifying the adductor canal, by using the in-plane technique, the probe will be placed at the mid-thigh, half the distance between the inguinal crease and the patella, for block location.
The superficial femoral artery will be visualized dorsal to the sartorius muscle.
Then, the probe will be removed to distally.
At this level, the hyperechoic view of the saphenous nerve will be visualized lateral and anterior to the artery in the subsartorial region.
5 mL of saline will be injected to confirm the proper injection site, and then a dose of 0.25% bupivacaine(Buvasin %5 flakon) 40ml will be injected here.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid consumption
Time Frame: Opioid consumption will be recorded at the first 48 hours period postoperatively
|
The primary aim is to compare perioperative and postoperative opioid consumption. Opioid consumption will be recorded at the first 48 hours period postoperatively. (postoperative 0-8, 8-16, 16-24, 24-48 hours) |
Opioid consumption will be recorded at the first 48 hours period postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")
Time Frame: Patients will be evaluated at the first 48 hours period postoperatively
|
Postoperative 48 hours period.
Patients' pain scores will be questioned at 0, 2, 4, 8, 16, 24 and 48 hours.
|
Patients will be evaluated at the first 48 hours period postoperatively
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Guven Kose S, Kose HC, Arslan G, Eler Cevik B, Tulgar S. Evaluation of ultrasound-guided adductor canal block with two different concentration of bupivacaine in arthroscopic knee surgery: A feasibility study. Int J Clin Pract. 2021 Nov;75(11):e14747. doi: 10.1111/ijcp.14747. Epub 2021 Sep 3.
- Ekinci M, Ciftci B, Demiraran Y, Celik EC, Yayik M, Omur B, Kuyucu E, Atalay YO. A comparison of adductor canal block before and after thigh tourniquet during knee arthroscopy: a randomized, blinded study. Korean J Anesthesiol. 2021 Dec;74(6):514-521. doi: 10.4097/kja.21040. Epub 2021 May 13.
- Frassanito L, Vergari A, Nestorini R, Cerulli G, Placella G, Pace V, Rossi M. Enhanced recovery after surgery (ERAS) in hip and knee replacement surgery: description of a multidisciplinary program to improve management of the patients undergoing major orthopedic surgery. Musculoskelet Surg. 2020 Apr;104(1):87-92. doi: 10.1007/s12306-019-00603-4. Epub 2019 May 3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
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
- BursaCityH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
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