- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04189640
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
Intervention / Treatment
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
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bagcilar
-
Istanbul, Bagcilar, Turkey, 34070
- Istanbul Medipol University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) classification I-II
- Scheduled for total knee arthroplasty under general 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 procedure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 20 = 20 ml volume adductor canal block
ACB will be performed at the end of the surgery, before extubation.
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 20ml will be injected here.
|
Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period.
A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
If the VAS score will be ≥ 4, 0.5 mg/ kg tramadol IV will be administered.
|
Active Comparator: Group 30 = 30 ml volume adductor canal block
ACB will be performed at the end of the surgery, before extubation.
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 30ml will be injected here.
|
Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period.
A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
If the VAS score will be ≥ 4, 0.5 mg/ kg tramadol IV will be administered.
|
Active Comparator: Group 40 = 40 ml volume adductor canal block
ACB will be performed at the end of the surgery, before extubation.
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 40ml will be injected here.
|
Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period.
A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
If the VAS score will be ≥ 4, 0.5 mg/ kg tramadol IV will be administered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid consumption
Time Frame: Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 and 48 hours
|
The primary aim is to compare perioperative and postoperative opioid consumption
|
Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 and 48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analogue scores (VAS)
Time Frame: Postoperative 1, 2, 4, 8, 16, 24, and 48 hours
|
Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt).
The VAS scores at rest and during cough will be recorded at postoperative 1, 2, 4, 8, 16, 24 and 48 hours.
|
Postoperative 1, 2, 4, 8, 16, 24, and 48 hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Jiang X, Wang QQ, Wu CA, Tian W. Analgesic Efficacy of Adductor Canal Block in Total Knee Arthroplasty: A Meta-analysis and Systematic Review. Orthop Surg. 2016 Aug;8(3):294-300. doi: 10.1111/os.12268.
- Kapoor R, Adhikary SD, Siefring C, McQuillan PM. The saphenous nerve and its relationship to the nerve to the vastus medialis in and around the adductor canal: an anatomical study. Acta Anaesthesiol Scand. 2012 Mar;56(3):365-7. doi: 10.1111/j.1399-6576.2011.02645.x.
- Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- Medipol Hospital 7
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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