Osteo Arthritis KneePhase 4NCT04155983
High Versus Low Adductor Canal Block
A Phase 4 study testing Ropivacaine in people with Osteo Arthritis Knee, run by Carilion Clinic at 1 site in United States.
Trial summary
The investigators will be comparing the efficacy of two different techniques for performing an adductor canal block to the saphenous nerve as a part of the multimodal pain control regimen for total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2020to 31 Dec 2021
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing unilateral primary TKA for primary osteoarthritis
- Age over 18
Who cannot join
- Pre-operative narcotic use
- Bilateral procedure
- Non-Primary arthroplasty
- Workman's comp
- Inability to have spinal anesthesia (blood thinners)
- Unsuccessful spinal anesthesia
Show all 9Show fewer
- Inflammatory or Post Traumatic arthritis
- ASA score of 4
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Carilion Institute for Orthopaedics & Neurosciences
Roanoke, Virginia, 24014
Sarah Smith, MSN, 540-512-1056, sfsmith@carilionclinic.org
About this study
Official title: Ultrasound Guided Adductor Canal Block vs Intra-Operative Trans-Articular Saphenous Nerve Block: A Prospective Trial
The investigators will be comparing the efficacy of two different techniques for performing an adductor canal block to the saphenous nerve as a part of the multimodal pain control regimen for total knee arthroplasty. The investigators will be comparing a "low adductor canal block" in which the surgeon administers local anesthetic to the distal aspect of the nerve from the operative site to a "high adductor canal block" in which the anesthesiologist administers the local anesthetic more proximally along the thigh using ultrasound guidance. The investigators will power the study for non-inferiority to compare the newer "low" block to the more commonly performed and more widely studied "high" block.
Read the detailed description
Study Design: Prospective RCT
Study Question- Does a surgeon administered intra-operative adductor canal block ("Low-ACB") provide non-inferior post-operative pain relief relative to anesthesia administered, ultrasound guided adductor canal block ("High-ACB").
Hypothesis- Surgeon administered Low-ACB provides non-inferior pain relief relative to anesthesia administered High-ACB.
Study Groups-
- US Guided, Anesthesia Administered Adductor Canal Block ("High ACB")
- Intra-Operative, Surgeon Administered Adductor Canal Block ("Low ACB")
Randomization- Cluster Randomization There will be two surgeons collecting data for this study; Surgeon A (principal investigator) \& Surgeon B. Each surgeon will begin collecting data on opposite arms of the study. Surgeon A will perform 35 consecutive High-ACB knees while Surgeon B performs 35 Low-ACB knees. After performing 35 knees under either the High-ACB or Low-ACB protocol, Surgeon A and Surgeon B will switch arms and perform an additional 35 consecutive knees in the opposite arm. At trial's end, each surgeon will have performed 35 TKAs using the High-ACB and Low-ACB protocol yielding a total of 70 patients in each arm.
Participant Timeline:
The investigators will interact with patients and collect specific data at a limited number of office visits as outlined below. All office appointments will take place at the Carilion Clinic Institute for Orthopaedics and Neurosciences.
- Pre-Op Appointment- Thorough informed consent will be obtained at this visit. Patient will be sent home with consent form to review further and discuss with family.
- Day of Surgery- Prior to surgery, operative team will go over consent one final time and obtain signature if patient consents.
- Post-Op Admission- Standard post-op protocol will be followed. Data will be collected from this admission from the Epic EMR as above.
- Discharge Home- Patient will keep pill journal for opioid narcotics taken each day as well as a recording their daily pain score prior to bed.
- 2 Week F/U Appointment- PROMIS, KOOS Jr. and VAS scores as well as physical exam data recorded. This requires no additional time as this is part of routine post TKA follow up.
- Home 2-6 Weeks- Patient will keep pill journal for opioid narcotics taken each day as well as a recording their daily pain score prior to bed.
- 6 Week F/U Appointment- PROMIS, KOOS Jr. and VAS scores as well as physical exam data recorded. This requires no additional time as this is part of routine post TKA follow up.
At this point, the patient has completed their participation in the study and will continue follow up as scheduled without further data collection.
Technical Details:
Surgeon Administered Group In the intra-operative cohort, the block will be administered after the final components are in place and cement debris is removed. The knee joint is irrigated with dilute hibiclens or betadine followed by pulsatile lavage per institutional protocol. A A blunt tip 1.5in 18ga needle was then used to administer 15cc of 0.5% ropivocaine.. The location of the saphenous nerve as it exits the adductor canal will be estimated to be 1.5x the TEA proximal to the medial epicondyle in men and 1.3x the TEA proximal in women as described by Kavolus et al.[3] The 60cc of the anesthetic will then injected through the vastus medialis musculature in a field extending from 1cm proximal to one cm distal to the assumed location of the nerve with the needle directed in from 20° to 45° medial. The wound is then irrigated pulsatile lavage one final time and closed in layered fashion.
Anesthesia Administered Group In the pre-operative cohort, the adductor canal block is administered by anesthesia staff immediately prior to patient transport to the operating room. The thigh is prepped with cholorhexidine at the midpoint between the anterior superior iliac spine and the patella and sterile drapes are applied. An ultrasound probe is then used to localize the adductor canal and confirm that the femoral artery, femoral vein and saphenous nerve can be visualized deep to the sartorious. The probe is moved proximally or distally until the neurovascular bundle is centered under the sartorius. A 20cc syringe with a blunt tip 1.5in 18ga needle is then used to inject 15cc of 0.5% ropivocaine. Following this, the wound is prepped and draped in usual sterile fashion for the arthroplasty procedure.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Ropivacaine
- Keywords
- gonarthrosis, osteoarthritis, knee, total knee arthroplasty, adductor canal block, saphenous nerve block, multimodal pain control
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called naropin
The drug will be administered in the same dosage in both arms. The location of the injection will vary by arm.
| Study group | Role | What they receive |
|---|---|---|
| High ACB | Active comparator | In the pre-operative cohort, the adductor canal block is administered by anesthesia staff immediately prior to patient transport to the operating room. The thigh is prepped with cholorhexidine at the midpoint between the anterior superior iliac spine and the patella and sterile drapes are applied. An ultrasound probe is then used to localize the adductor canal and confirm that the femoral artery, femoral vein and saphenous nerve can be visualized deep to the sartorious. The probe is moved proximally or distally until the neurovascular bundle is centered under the sartorius. A 20cc syringe with a blunt tip 1.5in 18ga needle is then used to inject 15cc of 0.5% ropivocaine. Following this, the wound is prepped and draped in usual sterile fashion for the arthroplasty procedure. Receives: Drug: Ropivacaine |
| Low ACB | Active comparator | Surgeon Administered Group In the intra-operative cohort, the block will be administered after the final components are in place and cement debris is removed. The knee joint is irrigated with dilute hibiclens or betadine followed by pulsatile lavage per institutional protocol. A blunt tip 1.5in 18ga needle was then used to administer 15cc of 0.5% ropivocaine.. The location of the saphenous nerve as it exits the adductor canal will be estimated to be 1.5x the TEA proximal to the medial epicondyle in men and 1.3x the TEA proximal in women as described by Kavolus et al. The 60cc of the anesthetic will then injected through the vastus medialis musculature in a field extending from 1cm proximal to one cm distal to the assumed location of the nerve with the needle directed in from 20° to 45° medial. The wound is then irrigated pulsatile lavage one final time and closed in layered fashion. Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Narcotic Consumption
Post-operative narcotic utilization measured in Morphine Equivalents per hour.
Measured: Up to 48 hours after surgery
Narcotic Consumption
Post-operative narcotic utilization measured in Morphine Equivalents per hour.
Measured: through study completion, an average of 6 weeks
Secondary outcomes (6)
Length of stay
Length of hospital stay after surgery measured in hours
Measured: through study completion, an average of 6 weeks
Visual Analog Scale Pain Scores
10 point validated patient reported pain scores with 0 being no pain and 10 being the worst pain the patient can imagine.
Measured: Recorded hourly while in hospital, daily after discharge up until 6wks
Inpatient therapy
Number of steps taken at each therapy session while in the hospital
Measured: Up to 48 hours after surgery
Patient Reported Outcome Measure Information System 10 Score
validated outcome measure using 10 questions and scored on a 50 point scale with 0 being the worst and 50 being the best overall score.
Measured: through study completion, an average of 6 weeks
Knee injury and Osteoarthritis Outcome Score Junior
validated outcome measure using 7 questions and scored on a 100 point scale such that 100 is the best score and 0 is the worst.
Measured: through study completion, an average of 6 weeks
Range of Motion
the flexion and extension range of motion in degrees of the patient recorded using a goniometer by the physical therapist while in the hospital and surgeon while in the clinic for follow up visits. Normal range of motion is 0-120 degrees.
Measured: through study completion, an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start11 Mar 2020
- Primary completion30 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study Design: Prospective RCT Study Groups: US Guided, Anesthesia Administered Adductor Canal Block ("High ACB") Intra-Operative, Surgeon Administered Adductor Canal Block ("Low ACB") Model- Cluster Randomization There will be two surgeons collecting data for this study; Dr. Mann (principal investigator) \& Dr. Moskal. Each surgeon will begin collecting data on opposite arms of the study. Surgeon A will perform 35 consecutive High-ACB knees while Surgeon B performs 35 Low-ACB knees. After performing 35 knees under either the High-ACB or Low-ACB protocol, Surgeon A and Surgeon B will switch arms and perform an additional 35 consecutive knees in the opposite arm. At trial's end, each surgeon will have performed 35 TKAs using the High-ACB and Low-ACB protocol yielding a total of 70 patients in each arm.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John W Mann, MD, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155983
- Sponsor's protocol ID
- IRB-19-643
- Status last verified
- Oct 2020
- First submitted
- 4 Nov 2019
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lund J, Jenstrup MT, Jaeger P, Sorensen AM, Dahl JB. Continuous adductor-canal-blockade for adjuvant post-operative analgesia after major knee surgery: preliminary results. Acta Anaesthesiol Scand. 2011 Jan;55(1):14-9. doi: 10.1111/j.1399-6576.2010.02333.x. Epub 2010 Oct 29.
PubMed 21039357Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.
PubMed 22221014Kapoor R, Adhikary SD, Siefring C, McQuillan PM. The saphenous nerve and its relationship to the nerve to the vastus medialis in and around the adductor canal: an anatomical study. Acta Anaesthesiol Scand. 2012 Mar;56(3):365-7. doi: 10.1111/j.1399-6576.2011.02645.x.
PubMed 22335278Pepper AM, North TW, Sunderland AM, Davis JJ. Intraoperative Adductor Canal Block for Augmentation of Periarticular Injection in Total Knee Arthroplasty: A Cadaveric Study. J Arthroplasty. 2016 Sep;31(9):2072-6. doi: 10.1016/j.arth.2016.02.030. Epub 2016 Feb 26.
PubMed 26996675Kavolus JJ, Sia D, Potter HG, Attarian DE, Lachiewicz PF. Saphenous Nerve Block From Within the Knee Is Feasible for TKA: MRI and Cadaveric Study. Clin Orthop Relat Res. 2018 Jan;476(1):30-36. doi: 10.1007/s11999.0000000000000006.
PubMed 29529612
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Adductor Canal Block vs Intra-Operative Trans-Articular Saphenous Nerve Block: A Prospective Trial
- ClinicalTrials.gov ID
- NCT04155983
- Acronym / sponsor ID
- IRB-19-643
- Conditions
- Osteo Arthritis Knee
- Keywords
- gonarthrosis, osteoarthritis, knee, total knee arthroplasty, adductor canal block, saphenous nerve block, multimodal pain control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 7 Nov 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 investigators will be comparing the efficacy of two different techniques for performing an adductor canal block to the saphenous nerve as a part of the multimodal pain control regimen for total knee arthroplasty. The investigators will be comparing a "low adductor canal block" in which the surgeon administers local anesthetic to the distal aspect of the nerve from the operative site to a "high adductor canal block" in which the anesthesiologist administers the local anesthetic more proximally along the thigh using ultrasound guidance. The investigators will power the study for non-inferiority to compare the newer "low" block to the more commonly performed and more widely studied "high" block.
Detailed description
Study Design: Prospective RCT
Study Question- Does a surgeon administered intra-operative adductor canal block ("Low-ACB") provide non-inferior post-operative pain relief relative to anesthesia administered, ultrasound guided adductor canal block ("High-ACB").
Hypothesis- Surgeon administered Low-ACB provides non-inferior pain relief relative to anesthesia administered High-ACB.
Study Groups-
- US Guided, Anesthesia Administered Adductor Canal Block ("High ACB")
- Intra-Operative, Surgeon Administered Adductor Canal Block ("Low ACB")
Randomization- Cluster Randomization There will be two surgeons collecting data for this study; Surgeon A (principal investigator) \& Surgeon B. Each surgeon will begin collecting data on opposite arms of the study. Surgeon A will perform 35 consecutive High-ACB knees while Surgeon B performs 35 Low-ACB knees. After performing 35 knees under either the High-ACB or Low-ACB protocol, Surgeon A and Surgeon B will switch arms and perform an additional 35 consecutive knees in the opposite arm. At trial's end, each surgeon will have performed 35 TKAs using the High-ACB and Low-ACB protocol yielding a total of 70 patients in each arm.
Participant Timeline:
The investigators will interact with patients and collect specific data at a limited number of office visits as outlined below. All office appointments will take place at the Carilion Clinic Institute for Orthopaedics and Neurosciences.
- Pre-Op Appointment- Thorough informed consent will be obtained at this visit. Patient will be sent home with consent form to review further and discuss with family.
- Day of Surgery- Prior to surgery, operative team will go over consent one final time and obtain signature if patient consents.
- Post-Op Admission- Standard post-op protocol will be followed. Data will be collected from this admission from the Epic EMR as above.
- Discharge Home- Patient will keep pill journal for opioid narcotics taken each day as well as a recording their daily pain score prior to bed.
- 2 Week F/U Appointment- PROMIS, KOOS Jr. and VAS scores as well as physical exam data recorded. This requires no additional time as this is part of routine post TKA follow up.
- Home 2-6 Weeks- Patient will keep pill journal for opioid narcotics taken each day as well as a recording their daily pain score prior to bed.
- 6 Week F/U Appointment- PROMIS, KOOS Jr. and VAS scores as well as physical exam data recorded. This requires no additional time as this is part of routine post TKA follow up.
At this point, the patient has completed their participation in the study and will continue follow up as scheduled without further data collection.
Technical Details:
Surgeon Administered Group In the intra-operative cohort, the block will be administered after the final components are in place and cement debris is removed. The knee joint is irrigated with dilute hibiclens or betadine followed by pulsatile lavage per institutional protocol. A A blunt tip 1.5in 18ga needle was then used to administer 15cc of 0.5% ropivocaine.. The location of the saphenous nerve as it exits the adductor canal will be estimated to be 1.5x the TEA proximal to the medial epicondyle in men and 1.3x the TEA proximal in women as described by Kavolus et al.[3] The 60cc of the anesthetic will then injected through the vastus medialis musculature in a field extending from 1cm proximal to one cm distal to the assumed location of the nerve with the needle directed in from 20° to 45° medial. The wound is then irrigated pulsatile lavage one final time and closed in layered fashion.
Anesthesia Administered Group In the pre-operative cohort, the adductor canal block is administered by anesthesia staff immediately prior to patient transport to the operating room. The thigh is prepped with cholorhexidine at the midpoint between the anterior superior iliac spine and the patella and sterile drapes are applied. An ultrasound probe is then used to localize the adductor canal and confirm that the femoral artery, femoral vein and saphenous nerve can be visualized deep to the sartorious. The probe is moved proximally or distally until the neurovascular bundle is centered under the sartorius. A 20cc syringe with a blunt tip 1.5in 18ga needle is then used to inject 15cc of 0.5% ropivocaine. Following this, the wound is prepped and draped in usual sterile fashion for the arthroplasty procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study Design: Prospective RCT Study Groups: US Guided, Anesthesia Administered Adductor Canal Block ("High ACB") Intra-Operative, Surgeon Administered Adductor Canal Block ("Low ACB") Model- Cluster Randomization There will be two surgeons collecting data for this study; Dr. Mann (principal investigator) \& Dr. Moskal. Each surgeon will begin collecting data on opposite arms of the study. Surgeon A will perform 35 consecutive High-ACB knees while Surgeon B performs 35 Low-ACB knees. After performing 35 knees under either the High-ACB or Low-ACB protocol, Surgeon A and Surgeon B will switch arms and perform an additional 35 consecutive knees in the opposite arm. At trial's end, each surgeon will have performed 35 TKAs using the High-ACB and Low-ACB protocol yielding a total of 70 patients in each arm.
| Arm | Type | Receives |
|---|---|---|
| High ACB | Active comparator | Drug: RopivacaineIn the pre-operative cohort, the adductor canal block is administered by anesthesia staff immediately prior to patient transport to the operating room. The thigh is prepped with cholorhexidine at the midpoint between the anterior superior iliac spine and the patella and sterile drapes are applied. An ultrasound probe is then used to localize the adductor canal and confirm that the femoral artery, femoral vein and saphenous nerve can be visualized deep to the sartorious. The probe is moved proximally or distally until the neurovascular bundle is centered under the sartorius. A 20cc syringe with a blunt tip 1.5in 18ga needle is then used to inject 15cc of 0.5% ropivocaine. Following this, the wound is prepped and draped in usual sterile fashion for the arthroplasty procedure. |
| Low ACB | Active comparator | Drug: RopivacaineSurgeon Administered Group In the intra-operative cohort, the block will be administered after the final components are in place and cement debris is removed. The knee joint is irrigated with dilute hibiclens or betadine followed by pulsatile lavage per institutional protocol. A blunt tip 1.5in 18ga needle was then used to administer 15cc of 0.5% ropivocaine.. The location of the saphenous nerve as it exits the adductor canal will be estimated to be 1.5x the TEA proximal to the medial epicondyle in men and 1.3x the TEA proximal in women as described by Kavolus et al. The 60cc of the anesthetic will then injected through the vastus medialis musculature in a field extending from 1cm proximal to one cm distal to the assumed location of the nerve with the needle directed in from 20° to 45° medial. The wound is then irrigated pulsatile lavage one final time and closed in layered fashion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients undergoing unilateral primary TKA for primary osteoarthritis
- Age over 18
Key exclusion criteria (9 listed)
- Pre-operative narcotic use
- Bilateral procedure
- Non-Primary arthroplasty
- Workman's comp
- Inability to have spinal anesthesia (blood thinners)
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 |
|---|---|---|
| RopivacaineAlso: naropinThe drug will be administered in the same dosage in both arms. The location of the injection will vary by arm. | Drug | High ACB, Low ACB |
Primary outcome
Narcotic Consumption
Time frame: Up to 48 hours after surgery
Post-operative narcotic utilization measured in Morphine Equivalents per hour.
Narcotic Consumption
Time frame: through study completion, an average of 6 weeks
Post-operative narcotic utilization measured in Morphine Equivalents per hour.
6 secondary outcomes
Length of stay
Time frame: through study completion, an average of 6 weeks
Visual Analog Scale Pain Scores
Time frame: Recorded hourly while in hospital, daily after discharge up until 6wks
Inpatient therapy
Time frame: Up to 48 hours after surgery
Patient Reported Outcome Measure Information System 10 Score
Time frame: through study completion, an average of 6 weeks
Knee injury and Osteoarthritis Outcome Score Junior
Time frame: through study completion, an average of 6 weeks
Range of Motion
Time frame: through study completion, an average of 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Background: PubMed 21039357Lund J, Jenstrup MT, Jaeger P, Sorensen AM, Dahl JB. Continuous adductor-canal-blockade for adjuvant post-operative analgesia after major knee surgery: preliminary results. Acta Anaesthesiol Scand. 2011 Jan;55(1):14-9. doi: 10.1111/j.1399-6576.2010.02333.x. Epub 2010 Oct 29.
- Background: PubMed 22221014Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.
- Background: PubMed 22335278Kapoor R, Adhikary SD, Siefring C, McQuillan PM. The saphenous nerve and its relationship to the nerve to the vastus medialis in and around the adductor canal: an anatomical study. Acta Anaesthesiol Scand. 2012 Mar;56(3):365-7. doi: 10.1111/j.1399-6576.2011.02645.x.
- Background: PubMed 26996675Pepper AM, North TW, Sunderland AM, Davis JJ. Intraoperative Adductor Canal Block for Augmentation of Periarticular Injection in Total Knee Arthroplasty: A Cadaveric Study. J Arthroplasty. 2016 Sep;31(9):2072-6. doi: 10.1016/j.arth.2016.02.030. Epub 2016 Feb 26.
- Background: PubMed 29529612Kavolus JJ, Sia D, Potter HG, Attarian DE, Lachiewicz PF. Saphenous Nerve Block From Within the Knee Is Feasible for TKA: MRI and Cadaveric Study. Clin Orthop Relat Res. 2018 Jan;476(1):30-36. doi: 10.1007/s11999.0000000000000006.
- Individual participant dataSharing planned: No
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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.
John W Mann, MD principal investigator
Carilion Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine in people with Osteo Arthritis Knee, run by Carilion Clinic 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 2 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: status not confirmed, as of the sponsor's last update on 30 Oct 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara F Smith ((540) 525-4917, sfsmith@carilionclinic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Narcotic Consumption (time frame: Up to 48 hours after surgery). The study lists 2 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 NCT04155983, which also lists 5 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 30 Oct 2020.