Ultrasound-Guided Adductor Canal Block for Total Knee Arthroplasty Surgery

Sponsor

Bursa City Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06084403

Collaborator

(none)

Enrollment

Location

Arms

1.7

Anticipated Duration (Months)

53.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Knee Disease Knee Deformity Knee Pain Chronic Knee Arthropathy Knee Osteoarthritis	Drug: 20 ml volume adductor canal block Drug: 30 ml volume adductor canal block Drug: 40 ml volume adductor canal block	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

There are threemodels for this study. 20 ml volume adductor canal block group, 30 ml volume adductor canal block group and 40 ml volume adductor canal block groupThere are threemodels for this study. 20 ml volume adductor canal block group, 30 ml volume adductor canal block group and 40 ml volume adductor canal block group

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

The patient and the outcomes assessor who performs postoperative pain evaluation will not know the group

Primary Purpose:

Treatment

Official Title:

The Efficacy of Different Volumes for Ultrasound-Guided Adductor Canal Block for Postoperative Analgesia Management After Total Knee Arthroplasty Surgery

Anticipated Study Start Date :

Oct 20, 2023

Anticipated Primary Completion Date :

Nov 20, 2023

Anticipated Study Completion Date :

Dec 10, 2023

Arms and Interventions

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.	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.
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.	Drug: 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.
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.	Drug: 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.

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.

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.

Active Comparator: 30 ml volume adductor canal block

Drug: 30 ml volume adductor canal block

Active Comparator: 40 ml volume adductor canal block

Drug: 40 ml volume adductor canal block

Outcome Measures

Primary Outcome Measures

Opioid consumption [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)

Secondary Outcome Measures

Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable") [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mürsel Ekinci	Bursa		Turkey

Sponsors and Collaborators

Bursa City Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Mursel Ekinci, MD, Assoc Prof, Bursa City Hospital

ClinicalTrials.gov Identifier:

NCT06084403

Other Study ID Numbers:

BursaCityH

First Posted:

Oct 16, 2023

Last Update Posted:

Oct 17, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mursel Ekinci, MD, Assoc Prof, Bursa City Hospital

Adductor Canal Block

Total Knee Arthroplasty

Postoperative Analgesia Management

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Joint Diseases

Study Results

No Results Posted as of Oct 17, 2023