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The Efficacy Of Ultrasound-Guided Adductor Canal Block for Arthroscopic Knee Surgery

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ClinicalTrials.gov Identifier: NCT04010916
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Bahadir Ciftci, Medipol University

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 usage of tourniquet during performing 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 timing of the tourniquet inflation for ACB is a topic of discussion.The aim of this study is to compare the different times of US-guided ACB performing for postoperative analgesia management after arthroscopic knee surgery.

Condition or disease Intervention/treatment Phase
Knee Arthropathy Other: Group Preoperatively Adductor Canal Block Other: Group Preoperatively Tourniquet Adductor Canal Block Other: Group Postoperatively Adductor Canal Block Not Applicable

Detailed Description:

Knee arthroscopy is one of the most common orthopedic procedures. Knee arthroscopy is commonly used for the repairement of meniscus tears, debridement and reshaping of cartilage flaps, and ligament reconstruction. Knee arthroscopy is a minimally invasive procedure, however patients may complain severe pain due to the port-site incisions and the ligaments in the knee joint. 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 blockadge 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 blockadge 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 an effective and safely block. It has been shown that usage of the tourniquet during performing the ACB block increases the spread of local anesthetics in a distal and proximal way. There are two questions in this issue. Firstly, the proximal spread of local anesthetics may cause possible quadriceps weakness. Secondly the distal spread of local anesthetics may increase analgesic effect via sciatic nerve blockade. In the routine surgical procedure, at the beginning of the surgery a tourniquet is attached to the thigh and inflated following the induction of anesthesia. Then at the end of the procedure the tourniquet is deinflated and the patient is extubated. ACB may be performed preoperatively or postoperatively. It may be performed before or after the inflation of the tourniquet.

The aim of this study is to compare the different performing times of US-guided ACB for postoperative analgesia management after arthroscopic knee surgery. The primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), and adverse effects related with opioids (allergic reaction, nausea, vomiting).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Ninety patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for arthroscopic knee surgery will be included in the study. Patients will be randomly divided into three groups (Group Pre = preoperatively before inflation of the tourniquet group, Group Pre-T = preoperatively after inflation of the tourniquet group, Group Post = Postoperatively group) including 30 patients each, before entering the operating room.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Outcomes Assessor and participant were blinded to the study
Primary Purpose: Treatment
Official Title: The Efficacy of Ultrasound-Guided Adductor Canal Block Timing for Postoperative Analgesia Management After Arthroscopic Knee Surgery
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Arm Intervention/treatment
Active Comparator: Group Pre = preoperatively before inflation of the tourniquet
ACB will be performed under general anesthesia in the supine position. 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
Other: Group Preoperatively Adductor Canal Block
The ACB will be performed preoperatively before inflation of the tourniquet. After identifing 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 remowed 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 30 mL will be injected here.

Active Comparator: Group Pre-T = preoperatively after inflation of the tourniquet
ACB will be performed under general anesthesia in the supine position. 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
Other: Group Preoperatively Tourniquet Adductor Canal Block
The ACB will be performed preoperatively after inflation of the tourniquet. After identifing 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 remowed 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 30 mL will be injected here.

Active Comparator: Group Post = Postoperatively group
ACB will be performed under general anesthesia in the supine position. 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
Other: Group Postoperatively Adductor Canal Block
The ACB will be performed postoperatively. After identifing 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 remowed 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 30 mL will be injected here.




Primary Outcome Measures :
  1. Opioid consumption [ Time Frame: Postoperative 24 hours ]
    Fentanyl using


Secondary Outcome Measures :
  1. Postoperative pain scores [ Time Frame: Postoperative 24 hours period ]
    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 0, 2, 4, 8, 16 and 24 hours.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) classification I-II
  • Scheduled for arthroscopic knee surgery under general anesthesia

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010916


Contacts
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Contact: Bahadir Ciftci, Asist.Prof +905325034428 bciftci@medipol.edu.tr

Locations
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Turkey
Istanbul Medipol University Hospital Recruiting
Istanbul, Bagcilar, Turkey, 34070
Contact: Bahadir Ciftci, MD    +905325034428    bciftci@medipol.edu.tr   
Contact: Mürsel Ekinci, MD    +905067137596    drmurselekinci@gmail.com   
Sponsors and Collaborators
Medipol University
Investigators
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Principal Investigator: Bahadir Ciftci, Asist.Prof Istanbul Medipol University

Publications:
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Responsible Party: Bahadir Ciftci, Principal Investigator, Medipol University
ClinicalTrials.gov Identifier: NCT04010916     History of Changes
Other Study ID Numbers: Medipol MH
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data (IPD) will not be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bahadir Ciftci, Medipol University:
Postoperative analgesia
Adductor canal block
Knee arthroscopy

Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases