Neuromuscular BlockNCT01791036
Adductor Canal Block In Anterior Cruciate Ligament (ACL) Repair
A study testing Adductor Canal Block and Femoral Nerve Block in people with Neuromuscular Block, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Adductor canal block will provide adequate analgesia to patients undergoing arthroscopic ACL reconstruction surgery, yet result in less motor blockade than a femoral block. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Neuromuscular Block
- What is being tested?
- Adductor Canal Block and Femoral Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- May 2013to Mar 2015
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists(ASA)classification I-III, Patients 18 to 50 years of age, BMI 18 - 40. Patients scheduled for anterior cruciate ligament reconstruction surgery under general anesthesia and nerve blocks.
Who cannot join
- Refusal or inability to provide informed consent. Any contraindication to regional anesthesia including coagulopathy or bleeding diathesis, allergy to local anesthetics, infection, nerve injury or malignancy at the site of the block.
- History of alcohol/drug dependence. History of long term opioid intake or chronic pain disorder. History of preexisting neuropathy in the operative leg History of significant psychiatric conditions that may affect patient assessment.
- Inability to understand the informed consent and demands of the study. Allergy to any of the components of the multimodal analgesic regimen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Analgesia Produced by Adductor Canal (Distal Femoral Artery Compartment) Block Is Not Inferior to Femoral Nerve Block In Outpatient Arthroscopic Anterior Cruciate Ligament Repair
Adductor canal block will provide adequate analgesia to patients undergoing arthroscopic ACL reconstruction surgery, yet result in less motor blockade than a femoral block.
Read the detailed description
This study is designed to demonstrate that postoperative analgesia produced by the adductor canal block is not inferior to that produced by femoral nerve block in patients undergoing arthroscopic ACL reconstruction surgery. The study will also compare the degree of motor blockade of the adductor canal block to that of the femoral nerve block.
- Conditions
- Neuromuscular Block
- Being tested
- Adductor Canal Block, Femoral Nerve Block
- Keywords
- Adductor canal block, Femoral Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor Canal BlockProcedure or surgery
Examination of the adductor canal using ultrasound will be performed using a high frequency linear probe. Following this the ultrasound probe will be positioned perpendicular to the skin in the medial upper-thigh region. The ultrasound probe will be moved either cephalad or caudad from its initial position in order to visualize the femoral artery immediately deep to the middle of the sartorius muscle. This point will then be selected as the appropriate level for needle insertion. Sham blocks using subcutaneous injection of normal saline will be used in both groups to maintain patient blinding.
Femoral Nerve BlockProcedure or surgery
Examination of the femoral nerve using ultrasound will be performed using a high frequency linear probe. Following this the ultrasound probe will be positioned perpendicular to the skin at the level of the femoral crease. The femoral artery will be identified and the femoral nerve will then be located immediately lateral to the artery, deep to the fascia iliaca and superficial to the iliopsoas muscle. The needle will be positioned next to the femoral nerve. Following this 20 ml of 0.25% bupivacaine with epinephrine will be injected incrementally over a 1 to 2 minute period. Sham blocks using subcutaneous injection of normal saline will be used in both groups to maintain patient blinding.
| Study group | Role | What they receive |
|---|---|---|
| Adductor Canal Block Group | Experimental | Adductor Canal Block Receives: Procedure: Adductor Canal Block |
| Femoral Nerve Block Group | Active comparator | Femoral Nerve Block Receives: Procedure: Femoral Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Postoperative cumulative opioid consumption during the first 24 hours. All doses of supplemental (PRN) oral and parenteral opioid analgesics required will be converted into equivalent doses of oral morphine
Measured: 24 hours
Motor Blockade
The degree of motor blockade 30 minutes following the block procedure
Measured: 30 minutes
Pain Scores
Visual Analog Pain scores at rest and with movement at admisssion and discharge from post-anesthesia care unit (PACU), AT DISCHARGE FROM same day surgery unit (SDC) and at 12, 24 and 48 hours
Measured: 12,24 and 48 hours
Secondary outcomes (2)
Sensory blockade
The degree of sensory blockade 30 minutes following the block procedure
Measured: 30 min
Spread of local anesthetic
Spread of local anesthetic from the injection site
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2015
- Study completionMar 2015
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 Neuromuscular BlockStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Chan, MD, Principal investigator, University of TorontoRichard Brull, MD, Principal investigator, UHN - Women's College Hospital and Toronto Western Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791036
- Sponsor's protocol ID
- 12-5231-B
- Status last verified
- Mar 2015
- First submitted
- 11 Feb 2013
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Williams BA, Kentor ML, Vogt MT, Irrgang JJ, Bottegal MT, West RV, Harner CD, Fu FH, Williams JP. Reduction of verbal pain scores after anterior cruciate ligament reconstruction with 2-day continuous femoral nerve block: a randomized clinical trial. Anesthesiology. 2006 Feb;104(2):315-27. doi: 10.1097/00000542-200602000-00018.
PubMed 16436852Dauri M, Fabbi E, Mariani P, Faria S, Carpenedo R, Sidiropoulou T, Coniglione F, Silvi MB, Sabato AF. Continuous femoral nerve block provides superior analgesia compared with continuous intra-articular and wound infusion after anterior cruciate ligament reconstruction. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):95-9. doi: 10.1097/AAP.0b013e31819baf98.
PubMed 19282706Sakura S, Hara K, Ota J, Tadenuma S. Ultrasound-guided peripheral nerve blocks for anterior cruciate ligament reconstruction: effect of obturator nerve block during and after surgery. J Anesth. 2010 Jun;24(3):411-7. doi: 10.1007/s00540-010-0916-3. Epub 2010 Mar 12.
PubMed 20225073
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesia Produced by Adductor Canal (Distal Femoral Artery Compartment) Block Is Not Inferior to Femoral Nerve Block In Outpatient Arthroscopic Anterior Cruciate Ligament Repair
- ClinicalTrials.gov ID
- NCT01791036
- Acronym / sponsor ID
- 12-5231-B
- Conditions
- Neuromuscular Block
- Keywords
- Adductor canal block, Femoral Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 Feb 2013 (estimated)
- 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.
Adductor canal block will provide adequate analgesia to patients undergoing arthroscopic ACL reconstruction surgery, yet result in less motor blockade than a femoral block.
Detailed description
This study is designed to demonstrate that postoperative analgesia produced by the adductor canal block is not inferior to that produced by femoral nerve block in patients undergoing arthroscopic ACL reconstruction surgery. The study will also compare the degree of motor blockade of the adductor canal block to that of the femoral nerve block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor Canal Block Group | Experimental | Procedure: Adductor Canal BlockAdductor Canal Block |
| Femoral Nerve Block Group | Active comparator | Procedure: Femoral Nerve BlockFemoral Nerve Block |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists(ASA)classification I-III, Patients 18 to 50 years of age, BMI 18 - 40. Patients scheduled for anterior cruciate ligament reconstruction surgery under general anesthesia and nerve blocks.
Key exclusion criteria (3 listed)
- Refusal or inability to provide informed consent. Any contraindication to regional anesthesia including coagulopathy or bleeding diathesis, allergy to local anesthetics, infection, nerve injury or malignancy at the site of the block.
- History of alcohol/drug dependence. History of long term opioid intake or chronic pain disorder. History of preexisting neuropathy in the operative leg History of significant psychiatric conditions that may affect patient assessment.
- Inability to understand the informed consent and demands of the study. Allergy to any of the components of the multimodal analgesic regimen.
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 |
|---|---|---|
| Adductor Canal BlockExamination of the adductor canal using ultrasound will be performed using a high frequency linear probe. Following this the ultrasound probe will be positioned perpendicular to the skin in the medial upper-thigh region. The ultrasound probe will be moved either cephalad or caudad from its initial position in order to visualize the femoral artery immediately deep to the middle of the sartorius muscle. This point will then be selected as the appropriate level for needle insertion. Sham blocks using subcutaneous injection of normal saline will be used in both groups to maintain patient blinding. | Procedure or surgery | Adductor Canal Block Group |
| Femoral Nerve BlockExamination of the femoral nerve using ultrasound will be performed using a high frequency linear probe. Following this the ultrasound probe will be positioned perpendicular to the skin at the level of the femoral crease. The femoral artery will be identified and the femoral nerve will then be located immediately lateral to the artery, deep to the fascia iliaca and superficial to the iliopsoas muscle. The needle will be positioned next to the femoral nerve. Following this 20 ml of 0.25% bupivacaine with epinephrine will be injected incrementally over a 1 to 2 minute period. Sham blocks using subcutaneous injection of normal saline will be used in both groups to maintain patient blinding. | Procedure or surgery | Femoral Nerve Block Group |
Primary outcome
Opioid consumption
Time frame: 24 hours
Postoperative cumulative opioid consumption during the first 24 hours. All doses of supplemental (PRN) oral and parenteral opioid analgesics required will be converted into equivalent doses of oral morphine
Motor Blockade
Time frame: 30 minutes
The degree of motor blockade 30 minutes following the block procedure
Pain Scores
Time frame: 12,24 and 48 hours
Visual Analog Pain scores at rest and with movement at admisssion and discharge from post-anesthesia care unit (PACU), AT DISCHARGE FROM same day surgery unit (SDC) and at 12, 24 and 48 hours
2 secondary outcomes
Sensory blockade
Time frame: 30 min
Spread of local anesthetic
Time frame: 30 min
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 4 Mar 2015.
- Background: PubMed 16436852Williams BA, Kentor ML, Vogt MT, Irrgang JJ, Bottegal MT, West RV, Harner CD, Fu FH, Williams JP. Reduction of verbal pain scores after anterior cruciate ligament reconstruction with 2-day continuous femoral nerve block: a randomized clinical trial. Anesthesiology. 2006 Feb;104(2):315-27. doi: 10.1097/00000542-200602000-00018.
- Background: PubMed 19282706Dauri M, Fabbi E, Mariani P, Faria S, Carpenedo R, Sidiropoulou T, Coniglione F, Silvi MB, Sabato AF. Continuous femoral nerve block provides superior analgesia compared with continuous intra-articular and wound infusion after anterior cruciate ligament reconstruction. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):95-9. doi: 10.1097/AAP.0b013e31819baf98.
- Background: PubMed 20225073Sakura S, Hara K, Ota J, Tadenuma S. Ultrasound-guided peripheral nerve blocks for anterior cruciate ligament reconstruction: effect of obturator nerve block during and after surgery. J Anesth. 2010 Jun;24(3):411-7. doi: 10.1007/s00540-010-0916-3. Epub 2010 Mar 12.
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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.
Vincent Chan, MD principal investigator
University of Toronto
Richard Brull, MD principal investigator
UHN - Women's College Hospital and Toronto Western Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adductor Canal Block and Femoral Nerve Block in people with Neuromuscular Block, run by University Health Network, Toronto at 1 site in Canada.
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 1 inclusion and 3 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 4 Mar 2015. 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 Canada. 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: 24 hours). The study lists 3 primary outcomes in all. 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 NCT01791036, 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 4 Mar 2015.