Osteoarthritis (Knee)NCT02081911
Total Knee Arthroplasty Utilizing Adductor Canal Block: Effect on Quadriceps Sparing
A study testing High Volume Adductor Canal Block, Low Volume Adductor Canal Block and Femoral Nerve Block in people with Osteoarthritis (Knee), run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether there is quantitative motor-sparing of the quadriceps muscles following adductor canal nerve block versus femoral nerve block. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis (Knee)
- What is being tested?
- High Volume Adductor Canal Block, Low Volume Adductor Canal Block and Femoral Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing primary unilateral total knee arthroplasty
- Planned use of combined spinal epidural (CSE) anesthesia
- Ability to follow study protocol
Who cannot join
- Contraindication to a spinal or epidural anesthetic
- Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)
- Allergy to local anesthetics
- Pre-existing neuropathy or weakness of the operative limb
- Any neuromuscular disorder
- Diabetes type I and II
Show all 9Show fewer
- Contraindication to a femoral nerve block or adductor canal nerve block
- Allergy or intolerance to any of the study medications
- BMI > 35 kg/m2
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Postoperative Pain Management Following Total Knee Arthroplasty Utilizing Adductor Canal Block: Effects on Pain Management and Quadriceps Sparing
The purpose of this study is to investigate whether there is quantitative motor-sparing of the quadriceps muscles following adductor canal nerve block versus femoral nerve block. Patients will be randomly placed into one of three treatment groups: 1) Femoral nerve block, 2) Adductor canal nerve block - low volume, or 3) Adductor canal nerve block - high volume. Quadriceps function will be assessed in the operating room using a skin patch and electrical stimulation. Follow up visits with the patients will continue over the course of 2 days during patient's stay at the hospital. A total of 60 patients will be enrolled for the study.
- Conditions
- Osteoarthritis (Knee)
- Being tested
- High Volume Adductor Canal Block, Low Volume Adductor Canal Block, Femoral Nerve Block
- Keywords
- adductor canal, femoral, quadriceps
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Volume Adductor Canal BlockProcedure or surgery
Adductor canal block performed in the distal thigh (1/3 of the total distance between the superior border of the patella and the femoral crease, cephalad to the patella) utilizing an injectate volume of 30 mL 0.25% bupivacaine/ epinephrine
Low Volume Adductor Canal BlockProcedure or surgery
Adductor canal block performed in the distal thigh (1/3 of the total distance between the superior border of the patella and the femoral crease, cephalad to the patella) utilizing an injectate volume of of 10 mL 0.75% bupivacaine/ epinephrine
Femoral Nerve BlockProcedure or surgery
Femoral nerve block with 10 mL 0.75 % bupivacaine/epinephrine
| Study group | Role | What they receive |
|---|---|---|
| High volume Adductor canal block | Experimental | Adductor canal block performed in the distal thigh (1/3 of the total distance between the superior border of the patella and the femoral crease, cephalad to the patella) utilizing an injectate volume of 30 mL 0.25% bupivacaine/ epinephrine Receives: Procedure: High Volume Adductor Canal Block |
| Low volume Adductor Canal Block | Experimental | Adductor canal block performed in the distal thigh (1/3 of the total distance between the superior border of the patella and the femoral crease, cephalad to the patella) utilizing an injectate volume of of 10 mL 0.75% bupivacaine/ epinephrine Receives: Procedure: Low Volume Adductor Canal Block |
| Femoral nerve block | Experimental | Femoral nerve block with 10 mL 0.75 % bupivacaine/epinephrine Receives: Procedure: Femoral Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps function as assessed by non-invasive transcutaneous nerve stimulation of the femoral nerve
After CSE effect, but prior to peripheral block, quadriceps function will be assessed by non-invasive transcutaneous nerve stimulation of the femoral nerve by placing an ECG electrode over the femoral location (determined by U/S) in the inguinal groove. The threshold amperage that produces patellar motion in response to electrical stimulation will be recorded. This threshold amperage will serve as a baseline value. Following the peripheral nerve block, transcutaneous stimulation will be repeated and, if still possible to elicit quadriceps contractions in response to electrical stimulation, the resulting new threshold amperage will be measured. The new threshold amperage will be expressed as a percentage of the baseline value and serve as a quantitative functional indication of the extent of quadriceps paresis resulting from the peripheral nerve block. The primary outcome will be quadriceps paralysis - yes/no.
Measured: 15 minutes after the placement of the peripheral nerve block (femoral or adductor canal)
Secondary outcomes (3)
Threshold amperage as a percentage of the baseline value
Following the peripheral nerve block, transcutaneous stimulation will be repeated and, if still possible to elicit quadriceps contractions in response to electrical stimulation, the resulting new threshold amperage will be measured. The new threshold amperage will be expressed as a percentage of the baseline value and serve as a quantitative functional indication of the extent of quadriceps paresis resulting from the peripheral nerve block.
Measured: 15 minutes after the placement of the peripheral nerve block
Analgesic adequacy
Analgesic adequacy as determined by pain scores (0-10) at spinal resolution (on average 2 hours post-op), 24 hours post-op and 48 hours post-op and daily epidural patient controlled analgesia consumption
Measured: Resolution of the spinal anesthetic (2 hours post-op), 24 and 48 hours post-op
Ability to complete a straight leg lift
Ability to complete and hold (for 3 seconds) a straight leg lift (from supine position) against gravity as evidence of meaningful quadriceps function - performed in holding area (baseline), at spinal resolution (on average 2 hours post-op), 24 hours post-op and 48 hours post-op
Measured: Holding area (baseline), at spinal resolution (2 hours post-op), 24 hours post-op and 48 hours post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis (Knee)Studies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Urmey, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081911
- Sponsor's protocol ID
- IRB #2014-005
- Status last verified
- Jan 2015
- First submitted
- 28 Feb 2014
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Vloka JD, Hadzic A, Lesser JB, Kitain E, Geatz H, April EW, Thys DM. A common epineural sheath for the nerves in the popliteal fossa and its possible implications for sciatic nerve block. Anesth Analg. 1997 Feb;84(2):387-90. doi: 10.1097/00000539-199702000-00028.
PubMed 9024035Davis JJ, Bond TS, Swenson JD. Adductor canal block: more than just the saphenous nerve? Reg Anesth Pain Med. 2009 Nov-Dec;34(6):618-9. doi: 10.1097/AAP.0b013e3181bfbf00. No abstract available.
PubMed 19901788
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Management Following Total Knee Arthroplasty Utilizing Adductor Canal Block: Effects on Pain Management and Quadriceps Sparing
- ClinicalTrials.gov ID
- NCT02081911
- Acronym / sponsor ID
- IRB #2014-005
- Conditions
- Osteoarthritis (Knee)
- Keywords
- adductor canal, femoral, quadriceps
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Mar 2014 (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.
The purpose of this study is to investigate whether there is quantitative motor-sparing of the quadriceps muscles following adductor canal nerve block versus femoral nerve block. Patients will be randomly placed into one of three treatment groups: 1) Femoral nerve block, 2) Adductor canal nerve block - low volume, or 3) Adductor canal nerve block - high volume. Quadriceps function will be assessed in the operating room using a skin patch and electrical stimulation. Follow up visits with the patients will continue over the course of 2 days during patient's stay at the hospital. A total of 60 patients will be enrolled for the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High volume Adductor canal block | Experimental | Procedure: High Volume Adductor Canal BlockAdductor canal block performed in the distal thigh (1/3 of the total distance between the superior border of the patella and the femoral crease, cephalad to the patella) utilizing an injectate volume of 30 mL 0.25% bupivacaine/ epinephrine |
| Low volume Adductor Canal Block | Experimental | Procedure: Low Volume Adductor Canal BlockAdductor canal block performed in the distal thigh (1/3 of the total distance between the superior border of the patella and the femoral crease, cephalad to the patella) utilizing an injectate volume of of 10 mL 0.75% bupivacaine/ epinephrine |
| Femoral nerve block | Experimental | Procedure: Femoral Nerve BlockFemoral nerve block with 10 mL 0.75 % bupivacaine/epinephrine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients undergoing primary unilateral total knee arthroplasty
- Planned use of combined spinal epidural (CSE) anesthesia
- Ability to follow study protocol
Key exclusion criteria (9 listed)
- Contraindication to a spinal or epidural anesthetic
- Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)
- Allergy to local anesthetics
- Pre-existing neuropathy or weakness of the operative limb
- Any neuromuscular disorder
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 |
|---|---|---|
| High Volume Adductor Canal BlockAdductor canal block performed in the distal thigh (1/3 of the total distance between the superior border of the patella and the femoral crease, cephalad to the patella) utilizing an injectate volume of 30 mL 0.25% bupivacaine/ epinephrine | Procedure or surgery | High volume Adductor canal block |
| Low Volume Adductor Canal BlockAdductor canal block performed in the distal thigh (1/3 of the total distance between the superior border of the patella and the femoral crease, cephalad to the patella) utilizing an injectate volume of of 10 mL 0.75% bupivacaine/ epinephrine | Procedure or surgery | Low volume Adductor Canal Block |
| Femoral Nerve BlockFemoral nerve block with 10 mL 0.75 % bupivacaine/epinephrine | Procedure or surgery | Femoral nerve block |
Primary outcome
Quadriceps function as assessed by non-invasive transcutaneous nerve stimulation of the femoral nerve
Time frame: 15 minutes after the placement of the peripheral nerve block (femoral or adductor canal)
After CSE effect, but prior to peripheral block, quadriceps function will be assessed by non-invasive transcutaneous nerve stimulation of the femoral nerve by placing an ECG electrode over the femoral location (determined by U/S) in the inguinal groove. The threshold amperage that produces patellar motion in response to electrical stimulation will be recorded. This threshold amperage will serve as a baseline value. Following the peripheral nerve block, transcutaneous stimulation will be repeated and, if still possible to elicit quadriceps contractions in response to electrical stimulation, the resulting new threshold amperage will be measured. The new threshold amperage will be expressed as a percentage of the baseline value and serve as a quantitative functional indication of the extent of quadriceps paresis resulting from the peripheral nerve block. The primary outcome will be quadriceps paralysis - yes/no.
3 secondary outcomes
Threshold amperage as a percentage of the baseline value
Time frame: 15 minutes after the placement of the peripheral nerve block
Analgesic adequacy
Time frame: Resolution of the spinal anesthetic (2 hours post-op), 24 and 48 hours post-op
Ability to complete a straight leg lift
Time frame: Holding area (baseline), at spinal resolution (2 hours post-op), 24 hours post-op and 48 hours post-op
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
- Results publication: PubMed 9024035Vloka JD, Hadzic A, Lesser JB, Kitain E, Geatz H, April EW, Thys DM. A common epineural sheath for the nerves in the popliteal fossa and its possible implications for sciatic nerve block. Anesth Analg. 1997 Feb;84(2):387-90. doi: 10.1097/00000539-199702000-00028.
- Results publication: PubMed 19901788Davis JJ, Bond TS, Swenson JD. Adductor canal block: more than just the saphenous nerve? Reg Anesth Pain Med. 2009 Nov-Dec;34(6):618-9. doi: 10.1097/AAP.0b013e3181bfbf00. No abstract available.
- Related InfoLink provided by the sponsor.
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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.
William Urmey, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Volume Adductor Canal Block, Low Volume Adductor Canal Block and Femoral Nerve Block in people with Osteoarthritis (Knee), run by Hospital for Special Surgery, New York at 1 site in United States.
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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 2 Feb 2016. 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 United States. 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 was stopped early. Results are not available in the source record.
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?
Quadriceps function as assessed by non-invasive transcutaneous nerve stimulation of the femoral nerve (time frame: 15 minutes after the placement of the peripheral nerve block (femoral or adductor canal)). 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 NCT02081911, which also lists 2 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 2 Feb 2016.