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

Primary Purpose

Knee Arthropathy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Group Preoperatively Adductor Canal Block
Group Preoperatively Tourniquet Adductor Canal Block
Group Postoperatively Adductor Canal Block
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Arthropathy focused on measuring Postoperative analgesia, Adductor canal block, Knee arthroscopy

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
  • 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

Sites / Locations

  • Istanbul Medipol University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group Pre = preoperatively before inflation of the tourniquet

Group Pre-T = preoperatively after inflation of the tourniquet

Group Post = Postoperatively group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Opioid consumption
Fentanyl using

Secondary Outcome Measures

Postoperative pain scores
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.

Full Information

First Posted
July 1, 2019
Last Updated
May 20, 2021
Sponsor
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT04010916
Brief Title
The Efficacy Of Ultrasound-Guided Adductor Canal Block for Arthroscopic Knee Surgery
Official Title
The Efficacy of Ultrasound-Guided Adductor Canal Block Timing for Postoperative Analgesia Management After Arthroscopic Knee Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
May 20, 2021 (Actual)
Study Completion Date
May 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University

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 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthropathy
Keywords
Postoperative analgesia, Adductor canal block, Knee arthroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
Outcomes Assessor and participant were blinded to the study
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Pre = preoperatively before inflation of the tourniquet
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group Pre-T = preoperatively after inflation of the tourniquet
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group Post = Postoperatively group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Group Preoperatively Adductor Canal Block
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Group Preoperatively Tourniquet Adductor Canal Block
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Group Postoperatively Adductor Canal Block
Intervention Description
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 Measure Information:
Title
Opioid consumption
Description
Fentanyl using
Time Frame
Postoperative 24 hours
Secondary Outcome Measure Information:
Title
Postoperative pain scores
Description
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.
Time Frame
Postoperative 24 hours period

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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bahadir Ciftci, Asist.Prof
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medipol University Hospital
City
Istanbul
State/Province
Bagcilar
ZIP/Postal Code
34070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) will not be shared
Citations:
PubMed Identifier
30345322
Citation
Kejriwal R, Cooper J, Legg A, Stanley J, Rosenfeldt MP, Walsh SJ. Efficacy of the Adductor Canal Approach to Saphenous Nerve Block for Anterior Cruciate Ligament Reconstruction With Hamstring Autograft: A Randomized Controlled Trial. Orthop J Sports Med. 2018 Oct 10;6(10):2325967118800948. doi: 10.1177/2325967118800948. eCollection 2018 Oct.
Results Reference
background
PubMed Identifier
23820968
Citation
Hanson NA, Derby RE, Auyong DB, Salinas FV, Delucca C, Nagy R, Yu Z, Slee AE. Ultrasound-guided adductor canal block for arthroscopic medial meniscectomy: a randomized, double-blind trial. Can J Anaesth. 2013 Sep;60(9):874-80. doi: 10.1007/s12630-013-9992-9. Epub 2013 Jul 3.
Results Reference
background
PubMed Identifier
26582853
Citation
Jaeger P, Jenstrup MT, Lund J, Siersma V, Brondum V, Hilsted KL, Dahl JB. Optimal volume of local anaesthetic for adductor canal block: using the continual reassessment method to estimate ED95. Br J Anaesth. 2015 Dec;115(6):920-6. doi: 10.1093/bja/aev362.
Results Reference
background

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

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