search
Back to results

Ultrasound-Guided Adductor Canal Block for Total Knee Arthroplasty Surgery

Primary Purpose

Knee Disease, Knee Deformity, Knee Pain Chronic

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
20 ml volume adductor canal block
30 ml volume adductor canal block
40 ml volume adductor canal block
Sponsored by
Bursa City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Disease focused on measuring Adductor Canal Block, Total Knee Arthroplasty, Postoperative Analgesia Management

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mürsel Ekinci

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

20 ml volume adductor canal block

30 ml volume adductor canal block

40 ml volume adductor canal block

Arm Description

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. 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. 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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Full Information

First Posted
September 30, 2023
Last Updated
October 14, 2023
Sponsor
Bursa City Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT06084403
Brief Title
Ultrasound-Guided Adductor Canal Block for Total Knee Arthroplasty Surgery
Official Title
The Efficacy of Different Volumes for Ultrasound-Guided Adductor Canal Block for Postoperative Analgesia Management After Total Knee Arthroplasty Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 20, 2023 (Anticipated)
Primary Completion Date
November 20, 2023 (Anticipated)
Study Completion Date
December 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bursa City Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Disease, Knee Deformity, Knee Pain Chronic, Knee Arthropathy, Knee Osteoarthritis
Keywords
Adductor Canal Block, Total Knee Arthroplasty, Postoperative Analgesia Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 group
Masking
ParticipantOutcomes Assessor
Masking Description
The patient and the outcomes assessor who performs postoperative pain evaluation will not know the group
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
20 ml volume adductor canal block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
30 ml volume adductor canal block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
40 ml volume adductor canal block
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
20 ml volume adductor canal block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
30 ml volume adductor canal block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
40 ml volume adductor canal block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Opioid consumption
Description
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)
Time Frame
Opioid consumption will be recorded at the first 48 hours period postoperatively
Secondary Outcome Measure Information:
Title
Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")
Description
Postoperative 48 hours period. Patients' pain scores will be questioned at 0, 2, 4, 8, 16, 24 and 48 hours.
Time Frame
Patients will be evaluated at the first 48 hours period postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mursel Ekinci
Phone
+905067137596
Email
drmurselekinci@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmet Kaciroglu
Email
akaciroglu@gmail.com
Facility Information:
Facility Name
Mürsel Ekinci
City
Bursa
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MÜRSEL EKİNCİ
Phone
05067137596
Email
drmurselekinci@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will not share IPD
Citations:
PubMed Identifier
34428334
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.
Results Reference
background
PubMed Identifier
33984219
Citation
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.
Results Reference
background
PubMed Identifier
31054080
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.
Results Reference
background

Learn more about this trial

Ultrasound-Guided Adductor Canal Block for Total Knee Arthroplasty Surgery

We'll reach out to this number within 24 hrs