Knee ArthropathyNCT04010916
The Efficacy Of Ultrasound-Guided Adductor Canal Block for Arthroscopic Knee Surgery
A study testing Group Preoperatively Adductor Canal Block, Group Preoperatively Tourniquet Adductor Canal Block and Group Postoperatively Adductor Canal Block in people with Knee Arthropathy, run by Medipol University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Knee Arthropathy
- What is being tested?
- Group Preoperatively Adductor Canal Block, Group Preoperatively Tourniquet Adductor Canal Block and Group Postoperatively Adductor Canal Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 20 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) classification I-II
- Scheduled for arthroscopic knee surgery under general anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Hospital
Istanbul, Bagcilar, 34070
About this study
Official title: The Efficacy of Ultrasound-Guided Adductor Canal Block Timing for Postoperative Analgesia Management After Arthroscopic Knee Surgery
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.
Read the 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).
- Conditions
- Knee Arthropathy
- Being tested
- Group Preoperatively Adductor Canal Block, Group Preoperatively Tourniquet Adductor Canal Block, Group Postoperatively Adductor Canal Block
- Keywords
- Postoperative analgesia, Adductor canal block, Knee arthroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Preoperatively Adductor Canal BlockOther
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.
Group Preoperatively Tourniquet Adductor Canal BlockOther
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.
Group Postoperatively Adductor Canal BlockOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group Pre = preoperatively before inflation of the tourniquet | Active comparator | 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 Receives: Other: Group Preoperatively Adductor Canal Block |
| Group Pre-T = preoperatively after inflation of the tourniquet | Active comparator | 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 Receives: Other: Group Preoperatively Tourniquet Adductor Canal Block |
| Group Post = Postoperatively group | Active comparator | 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 Receives: Other: Group Postoperatively Adductor Canal Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Fentanyl using
Measured: Postoperative 24 hours
Secondary outcomes (1)
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.
Measured: Postoperative 24 hours period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start1 Jul 2019
- Primary completion20 May 2021
- Study completion20 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahadir Ciftci, Medipol University
- Investigators
- Bahadir Ciftci, Asist.Prof, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010916
- Sponsor's protocol ID
- Medipol MH
- Status last verified
- May 2021
- First submitted
- 1 Jul 2019
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared
Publications
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.
PubMed 30345322Hanson 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.
PubMed 23820968Jaeger 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.
PubMed 26582853
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Ultrasound-Guided Adductor Canal Block Timing for Postoperative Analgesia Management After Arthroscopic Knee Surgery
- ClinicalTrials.gov ID
- NCT04010916
- Acronym / sponsor ID
- Medipol MH
- Conditions
- Knee Arthropathy
- Keywords
- Postoperative analgesia, Adductor canal block, Knee arthroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group Pre = preoperatively before inflation of the tourniquet | Active comparator | Other: Group Preoperatively Adductor Canal BlockACB 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 |
| Group Pre-T = preoperatively after inflation of the tourniquet | Active comparator | Other: Group Preoperatively Tourniquet Adductor Canal BlockACB 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 |
| Group Post = Postoperatively group | Active comparator | Other: Group Postoperatively Adductor Canal BlockACB 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) classification I-II
- Scheduled for arthroscopic knee surgery under general anesthesia
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Preoperatively Adductor Canal BlockThe 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. | Other | Group Pre = preoperatively before inflation of the tourniquet |
| Group Preoperatively Tourniquet Adductor Canal BlockThe 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. | Other | Group Pre-T = preoperatively after inflation of the tourniquet |
| Group Postoperatively Adductor Canal BlockThe 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. | Other | Group Post = Postoperatively group |
Primary outcome
Opioid consumption
Time frame: Postoperative 24 hours
Fentanyl using
1 secondary outcome
Postoperative pain scores
Time frame: Postoperative 24 hours period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Background: PubMed 30345322Kejriwal 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.
- Background: PubMed 23820968Hanson 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.
- Background: PubMed 26582853Jaeger 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bahadir Ciftci, Asist.Prof principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Preoperatively Adductor Canal Block, Group Preoperatively Tourniquet Adductor Canal Block and Group Postoperatively Adductor Canal Block in people with Knee Arthropathy, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (time frame: Postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04010916, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.