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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06084403
Other study ID # BursaCityH
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 20, 2023
Est. completion date May 10, 2024

Study information

Verified date April 2024
Source Bursa City Hospital
Contact Mursel Ekinci
Phone +905067137596
Email drmurselekinci@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The ultrasound-guided selective blockade of the saphenous nerve in the adductor canal provides effective analgesia and reduces postoperative pain in patients undergoing arthroscopic medial meniscectomy. Selective blockade of the saphenous nerve in the adductor canal provides effective analgesia without quadriceps muscle weakness. It has been shown that the adductor canal block (ACB) block increases the spread of local anesthetics in a distal and proximal way. Therefore, the proximal spread of local anesthetics may cause possible quadriceps weakness. The distal spread of local anesthetics may increase analgesic effect via sciatic nerve. The different volumes for ACB is a topic of discussion. The aim of this study is to compare the different volumes of US-guided ACB performing for postoperative analgesia management after total knee arthroplasty surgery.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date May 10, 2024
Est. primary completion date March 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Drug:
20 ml volume adductor canal block
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.
30 ml volume adductor canal block
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.
40 ml volume adductor canal block
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.

Locations

Country Name City State
Turkey Mürsel Ekinci Bursa

Sponsors (1)

Lead Sponsor Collaborator
Bursa City Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Opioid consumption 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 Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable") 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
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