Postoperative PainPhase 4NCT02788019
Adductor Canal Mid-thigh and Adductor Canal Distal Thigh: Is Cutaneous Sensory Blockade Similar Among Block Techniques?
A Phase 4 study testing Ropivacaine in people with Postoperative Pain, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a randomized noninferiority interventional study to determine the equivalence of two adductor canal block (ACB) methods: mid-thigh and distal thigh in patients undergoing medial foot, medial ankle, or medial leg surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2016to 23 Mar 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Individuals undergoing surgery of the medial foot, medial ankle, or medial leg for which the anesthetic plan includes an adductor canal nerve block
Who cannot join
- Any known deficit of the ipsilateral lumbar nerve roots, ipsilateral lumbar plexus, ipsilateral femoral nerve, obturator nerve or saphenous nerve including diabetic peripheral neuropathy
- Any local disorder of the skin or otherwise where blockade is to be performed
- Body mass index >50
- American Society of Anesthesiologists (ASA) classification greater than 3
- Allergy to amide local anesthetic medications
- Pregnancy
- Incarceration
- Inability to understand study procedures including inability to understand the English language
Trial locations and contacts
1 site in 1 country.
United States1 site
Zale Lipshy University Hospital
Dallas, Texas, 75390
About this study
This is a randomized noninferiority interventional study to determine the equivalence of two adductor canal block (ACB) methods: mid-thigh and distal thigh in patients undergoing medial foot, medial ankle, or medial leg surgery. Sixty eight patients will be identified during their orthopedic presurgical clinic visit, anesthesia preoperative clinic visit or Day Surgery Unit (Zale Lipshy Hospital, Clements University Hospital, and University of Texas Southwestern Outpatient Surgery Center) for eligibility. Eligible individuals may be introduced to the study in the orthopedic presurgical clinic or the anesthesia preoperative clinic by staff. After consent patients will be randomized (break-seal method) to receive either a mid-thigh or distal thigh block using ropivacaine prior to foot, ankle, or leg surgery. The following measurements will be obtained to determine the change in sensory distribution: pinprick test with Neuropen, maximum voluntary isometric contraction before and after block, postoperative pain scores (24 hrs and at discharge) and postoperative opiate consumption.
Read the detailed description
Potential subjects will be identified at the orthopedic presurgical clinic, the anesthesia preoperative clinic or the Day Surgery Unit. The electronic medical record (Epic) will also be used for prescreening potential subjects. Recruitment and consenting at will occur at anesthesia preoperative clinics, Day Surgery Unit. A computer generated randomization list will be used for randomization list. The research intervention of this study will take place within the standard clinical context. The patient will receive an ACB regardless of their participation in this research in accordance with their anesthetic plan and their desires The experiment will be conducted as follows: A 20-point grid will be drawn on the subject's leg that will receive medial foot, ankle or leg surgery. Two baseline measurements will be taken prior to administration of the adductor block: distribution of sensation using pinprick (Neuropen) method, and muscle contraction strength using a dynamometer. The number of grid cells with sensation will be counted and recorded. The randomized block will be administered allowing 20 minutes for anesthetic to take full effect. Post-block measurements include pinprick in each of the grid cells, where patient will indicate whether sensation is felt or not. The cells where sensation is perceived will be circled and number of cells will be recorded. After sensation is recorded, maximum voluntary isometric contraction (MVIC) will again be measured with the dynamometer to record the maximal contraction strength. Within 24 hours of surgery, the subject will be asked to rate their pain on a scale of 0-10, and will be recorded again after discharge, in conjunction with opiates required to reduce pain. A more detailed explanation of experimental steps can be read below.
20-Point Grid: The 20-point grid will be marked starting with anatomical landmarks at the knee joint: the medial inter-knee joint where the tibia meets the femur, the mid medial patella, the mid lateral patella, and along the same line at the semitendinosus tendon at 5 cm posterior from that point. Then 5 cm intervals will be plotted progressing cephalad to a total of 15 cm.
Neuropen test:
Prior to administration of randomized blockade technique a pinprick test will be administered using a Neuropen on a scale of 0-1, with 1-normal sharp sensation and 0=dull change of sensation. Mechanical stimulation with pinprick testing is routinely used to test nociception in the bedside neurologic examination. Sharpness can be considered a surrogate for nociception because whereas sharpness is not necessarily painful, mechanical thresholds for sharpness closely parallel those for pain. The subject will be asked to determine whether the stimulus feels sharp. The number of grid-points with a change in sensation from baseline will be recorded at baseline and 20 minutes after the block.
MVIC:
Additionally, MVIC will be measured by a handheld dynamometer (Lafayette Instrument Company, Lafayette Indiana) to determine muscle strength at baseline and after the adductor block. The patient will be in a seated position with the thigh parallel to the floor and the knee at a 90-degree angle with the feet off the floor. The dynamometer is applied to the leg 5 cm above the transmalleolar axis and perpendicular to the tibial crest. The patient is instructed to extend the leg at the knee with sustained maximal force for 5 seconds. This will be repeated 3 times with 30 seconds rest between each movement, and the force will be recorded (Newtons).
Adductor Canal Blockade The adductor canal block will be performed using a linear HFL38xp or a linear HFL38x ultrasound probe (X-Porte or M-Turbo; SonoSite; Bothell, Washington). The site that is to receive the ACB will be sterilized with chlorhexidine gluconate 2% and 70% isopropyl alcohol prep. A skin weal of lidocaine 1% (2-5mL) will be delivered. A Tuohy needle (17 gauges) will be inserted through the skin wheal under ultrasound guidance towards the target nerve location. Ropivacaine 0.5% 15ml will be injected for either adductor canal locations.27 Pain Scores and Opiate Consumption A follow-up visit will be performed in person for inpatients or via phone for outpatients within 24 hours from discharge to assess for pain control, and monitoring side effects. It will take 10 minutes. Adverse events will be monitored during the 24-hour period of the study.
Potential Risks Potential risks include loss of confidentiality or mild discomfort associated with the pinprick for sensory testing. Risks that are involved with administration of ropivacaine are primarily damage to surrounding tissues, including nerves, and may cause bleeding or infection from injection or an unknown allergy to ropivacaine that develops during the administration of the drug. There are no additional physical or psychological risks that may result from participation in this research protocol since patients will have determined that they desire perineural blockade before study inclusion is even proposed.
Subject Safety and Data Monitoring Any serious adverse reaction, including allergy and local anesthetic systemic toxicity, will result in immediate discontinuation of study related procedures and treatment as necessary. Serious adverse events will be reported to the Institutional Review Board. The data already obtained from a participant who has had a serious adverse event will be analyzed according to intention-to-treat principle.
If non-inferiority between the two neurosensory blockade techniques is significantly detected at 50% enrollment (or enrollment of 34 patients), the study will be stopped. The study will also be stopped in the event that there is overwhelming statistical evidence at interim analysis that the two blocks are different, or in the very small chance that there are multiple adverse events in the study population.
- Conditions
- Postoperative Pain
- Being tested
- Ropivacaine
- Keywords
- Adductor canal block, nerve block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Ropivacaine is routinely used to perform localized blockade prior to surgery to improve management of postoperative pain.
| Study group | Role | What they receive |
|---|---|---|
| Mid-Thigh Adductor Block | Experimental | Subject will receive a mid-thigh adductor block method using ropivacaine (0.5%, 15 mL). Receives: Drug: Ropivacaine |
| Distal-Thigh Adductor Block | Active comparator | Subject will receive a distal-thigh adductor block method using ropivacaine (0.5%, 15 mL). Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Grid Points With Change of Sensation to Pinprick After Blockade
The distribution of cutaneous sensation affected by the different techniques of adductor canal blockade is assessed using a monofilament Neuropen to prick points on a 20 point grid applied to the skin in a standard fashion according to this method: A grid will be marked starting with anatomical landmarks at the knee joint: the medial inter-knee-joint point where the tibia meets the femur, the mid medial patella, the mid lateral patella, and along the same line at the semitendinosus tendon and 5cm posterior from that point. Then 5cm intervals will be plotted progressing cephalad to a total of 15 centimeters. This will yield 20 grid points (5x4 points). Once the grid is made, testing proceeds with a Neuropen on a scale of 0-1, with 1 = normal sharp sensation, 0 = change of sensation. The Neuropen is used for the standardization of force.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study start26 May 2016
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
Why it stopped: Unable to complete the sample size needed for 80% power due to changes in surgical approach to adductor block usage.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Machi, University of Texas Southwestern Medical Center
- Investigators
- Anthony Machi, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788019
- Sponsor's protocol ID
- STU 092015-065
- Status last verified
- Mar 2021
- First submitted
- 20 May 2016
- Last updated
- 21 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.
PubMed 19916251Davis 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 19901788Jaeger P, Grevstad U, Henningsen MH, Gottschau B, Mathiesen O, Dahl JB. Effect of adductor-canal-blockade on established, severe post-operative pain after total knee arthroplasty: a randomised study. Acta Anaesthesiol Scand. 2012 Sep;56(8):1013-9. doi: 10.1111/j.1399-6576.2012.02737.x. Epub 2012 Jul 26.
PubMed 22834681Tubbs RS, Loukas M, Shoja MM, Apaydin N, Oakes WJ, Salter EG. Anatomy and potential clinical significance of the vastoadductor membrane. Surg Radiol Anat. 2007 Oct;29(7):569-73. doi: 10.1007/s00276-007-0230-4. Epub 2007 Jul 7.
PubMed 17618402Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b.
PubMed 23241723Machi AT, Sztain JF, Kormylo NJ, Madison SJ, Abramson WB, Monahan AM, Khatibi B, Ball ST, Gonzales FB, Sessler DI, Mascha EJ, You J, Nakanote KA, Ilfeld BM. Discharge Readiness after Tricompartment Knee Arthroplasty: Adductor Canal versus Femoral Continuous Nerve Blocks-A Dual-center, Randomized Trial. Anesthesiology. 2015 Aug;123(2):444-56. doi: 10.1097/ALN.0000000000000741.
PubMed 26079800Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.
PubMed 24401769Bendtsen TF, Moriggl B, Chan V, Pedersen EM, Borglum J. Defining adductor canal block. Reg Anesth Pain Med. 2014 May-Jun;39(3):253-4. doi: 10.1097/AAP.0000000000000052. No abstract available.
PubMed 24747312Horn JL, Pitsch T, Salinas F, Benninger B. Anatomic basis to the ultrasound-guided approach for saphenous nerve blockade. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):486-9. doi: 10.1097/AAP.0b013e3181ae11af.
PubMed 19920424Bendtsen TF, Moriggl B, Chan V, Pedersen EM, Borglum J. Redefining the adductor canal block. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):442-3. doi: 10.1097/AAP.0000000000000119. No abstract available.
PubMed 25140514Jaeger P, Lund J, Jenstrup MT, Brondum V, Dahl JB. Reply to Dr Bendtsen. Reg Anesth Pain Med. 2014 May-Jun;39(3):254-5. doi: 10.1097/AAP.0000000000000069. No abstract available.
PubMed 24747313Cowlishaw P, Kotze P. Adductor canal block--or subsartorial canal block? Reg Anesth Pain Med. 2015 Mar-Apr;40(2):175-6. doi: 10.1097/AAP.0000000000000205. No abstract available.
PubMed 25688724Bendtsen TF, Moriggl B, Chan V, Borglum J. Basic Topography of the Saphenous Nerve in the Femoral Triangle and the Adductor Canal. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):391-2. doi: 10.1097/AAP.0000000000000261. No abstract available.
PubMed 26079358Benzon HT, Sharma S, Calimaran A. Comparison of the different approaches to saphenous nerve block. Anesthesiology. 2005 Mar;102(3):633-8. doi: 10.1097/00000542-200503000-00023.
PubMed 15731603Lopez AM, Sala-Blanch X, Magaldi M, Poggio D, Asuncion J, Franco CD. Ultrasound-guided ankle block for forefoot surgery: the contribution of the saphenous nerve. Reg Anesth Pain Med. 2012 Sep-Oct;37(5):554-7. doi: 10.1097/AAP.0b013e3182611483.
PubMed 22854395
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adductor Canal Mid-thigh and Adductor Canal Distal Thigh: Is Cutaneous Sensory Blockade Similar Among Block Techniques?
- ClinicalTrials.gov ID
- NCT02788019
- Acronym / sponsor ID
- STU 092015-065
- Conditions
- Postoperative Pain
- Keywords
- Adductor canal block, nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to complete the sample size needed for 80% power due to changes in surgical approach to adductor block usage.
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 26 May 2016 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 2 Jun 2016 (estimated)
- Results
- Posted 21 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized noninferiority interventional study to determine the equivalence of two adductor canal block (ACB) methods: mid-thigh and distal thigh in patients undergoing medial foot, medial ankle, or medial leg surgery. Sixty eight patients will be identified during their orthopedic presurgical clinic visit, anesthesia preoperative clinic visit or Day Surgery Unit (Zale Lipshy Hospital, Clements University Hospital, and University of Texas Southwestern Outpatient Surgery Center) for eligibility. Eligible individuals may be introduced to the study in the orthopedic presurgical clinic or the anesthesia preoperative clinic by staff. After consent patients will be randomized (break-seal method) to receive either a mid-thigh or distal thigh block using ropivacaine prior to foot, ankle, or leg surgery. The following measurements will be obtained to determine the change in sensory distribution: pinprick test with Neuropen, maximum voluntary isometric contraction before and after block, postoperative pain scores (24 hrs and at discharge) and postoperative opiate consumption.
Detailed description
Potential subjects will be identified at the orthopedic presurgical clinic, the anesthesia preoperative clinic or the Day Surgery Unit. The electronic medical record (Epic) will also be used for prescreening potential subjects. Recruitment and consenting at will occur at anesthesia preoperative clinics, Day Surgery Unit. A computer generated randomization list will be used for randomization list. The research intervention of this study will take place within the standard clinical context. The patient will receive an ACB regardless of their participation in this research in accordance with their anesthetic plan and their desires The experiment will be conducted as follows: A 20-point grid will be drawn on the subject's leg that will receive medial foot, ankle or leg surgery. Two baseline measurements will be taken prior to administration of the adductor block: distribution of sensation using pinprick (Neuropen) method, and muscle contraction strength using a dynamometer. The number of grid cells with sensation will be counted and recorded. The randomized block will be administered allowing 20 minutes for anesthetic to take full effect. Post-block measurements include pinprick in each of the grid cells, where patient will indicate whether sensation is felt or not. The cells where sensation is perceived will be circled and number of cells will be recorded. After sensation is recorded, maximum voluntary isometric contraction (MVIC) will again be measured with the dynamometer to record the maximal contraction strength. Within 24 hours of surgery, the subject will be asked to rate their pain on a scale of 0-10, and will be recorded again after discharge, in conjunction with opiates required to reduce pain. A more detailed explanation of experimental steps can be read below.
20-Point Grid: The 20-point grid will be marked starting with anatomical landmarks at the knee joint: the medial inter-knee joint where the tibia meets the femur, the mid medial patella, the mid lateral patella, and along the same line at the semitendinosus tendon at 5 cm posterior from that point. Then 5 cm intervals will be plotted progressing cephalad to a total of 15 cm.
Neuropen test:
Prior to administration of randomized blockade technique a pinprick test will be administered using a Neuropen on a scale of 0-1, with 1-normal sharp sensation and 0=dull change of sensation. Mechanical stimulation with pinprick testing is routinely used to test nociception in the bedside neurologic examination. Sharpness can be considered a surrogate for nociception because whereas sharpness is not necessarily painful, mechanical thresholds for sharpness closely parallel those for pain. The subject will be asked to determine whether the stimulus feels sharp. The number of grid-points with a change in sensation from baseline will be recorded at baseline and 20 minutes after the block.
MVIC:
Additionally, MVIC will be measured by a handheld dynamometer (Lafayette Instrument Company, Lafayette Indiana) to determine muscle strength at baseline and after the adductor block. The patient will be in a seated position with the thigh parallel to the floor and the knee at a 90-degree angle with the feet off the floor. The dynamometer is applied to the leg 5 cm above the transmalleolar axis and perpendicular to the tibial crest. The patient is instructed to extend the leg at the knee with sustained maximal force for 5 seconds. This will be repeated 3 times with 30 seconds rest between each movement, and the force will be recorded (Newtons).
Adductor Canal Blockade The adductor canal block will be performed using a linear HFL38xp or a linear HFL38x ultrasound probe (X-Porte or M-Turbo; SonoSite; Bothell, Washington). The site that is to receive the ACB will be sterilized with chlorhexidine gluconate 2% and 70% isopropyl alcohol prep. A skin weal of lidocaine 1% (2-5mL) will be delivered. A Tuohy needle (17 gauges) will be inserted through the skin wheal under ultrasound guidance towards the target nerve location. Ropivacaine 0.5% 15ml will be injected for either adductor canal locations.27 Pain Scores and Opiate Consumption A follow-up visit will be performed in person for inpatients or via phone for outpatients within 24 hours from discharge to assess for pain control, and monitoring side effects. It will take 10 minutes. Adverse events will be monitored during the 24-hour period of the study.
Potential Risks Potential risks include loss of confidentiality or mild discomfort associated with the pinprick for sensory testing. Risks that are involved with administration of ropivacaine are primarily damage to surrounding tissues, including nerves, and may cause bleeding or infection from injection or an unknown allergy to ropivacaine that develops during the administration of the drug. There are no additional physical or psychological risks that may result from participation in this research protocol since patients will have determined that they desire perineural blockade before study inclusion is even proposed.
Subject Safety and Data Monitoring Any serious adverse reaction, including allergy and local anesthetic systemic toxicity, will result in immediate discontinuation of study related procedures and treatment as necessary. Serious adverse events will be reported to the Institutional Review Board. The data already obtained from a participant who has had a serious adverse event will be analyzed according to intention-to-treat principle.
If non-inferiority between the two neurosensory blockade techniques is significantly detected at 50% enrollment (or enrollment of 34 patients), the study will be stopped. The study will also be stopped in the event that there is overwhelming statistical evidence at interim analysis that the two blocks are different, or in the very small chance that there are multiple adverse events in the study population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mid-Thigh Adductor Block | Experimental | Drug: RopivacaineSubject will receive a mid-thigh adductor block method using ropivacaine (0.5%, 15 mL). |
| Distal-Thigh Adductor Block | Active comparator | Drug: RopivacaineSubject will receive a distal-thigh adductor block method using ropivacaine (0.5%, 15 mL). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18 years or older
- Individuals undergoing surgery of the medial foot, medial ankle, or medial leg for which the anesthetic plan includes an adductor canal nerve block
Key exclusion criteria (8 listed)
- Any known deficit of the ipsilateral lumbar nerve roots, ipsilateral lumbar plexus, ipsilateral femoral nerve, obturator nerve or saphenous nerve including diabetic peripheral neuropathy
- Any local disorder of the skin or otherwise where blockade is to be performed
- Body mass index >50
- American Society of Anesthesiologists (ASA) classification greater than 3
- Allergy to amide local anesthetic medications
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 |
|---|---|---|
| RopivacaineRopivacaine is routinely used to perform localized blockade prior to surgery to improve management of postoperative pain. | Drug | Distal-Thigh Adductor Block, Mid-Thigh Adductor Block |
Primary outcome
Number of Grid Points With Change of Sensation to Pinprick After Blockade
Time frame: 20 minutes
The distribution of cutaneous sensation affected by the different techniques of adductor canal blockade is assessed using a monofilament Neuropen to prick points on a 20 point grid applied to the skin in a standard fashion according to this method: A grid will be marked starting with anatomical landmarks at the knee joint: the medial inter-knee-joint point where the tibia meets the femur, the mid medial patella, the mid lateral patella, and along the same line at the semitendinosus tendon and 5cm posterior from that point. Then 5cm intervals will be plotted progressing cephalad to a total of 15 centimeters. This will yield 20 grid points (5x4 points). Once the grid is made, testing proceeds with a Neuropen on a scale of 0-1, with 1 = normal sharp sensation, 0 = change of sensation. The Neuropen is used for the standardization of force.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19916251Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.
- Background: 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.
- Background: PubMed 22834681Jaeger P, Grevstad U, Henningsen MH, Gottschau B, Mathiesen O, Dahl JB. Effect of adductor-canal-blockade on established, severe post-operative pain after total knee arthroplasty: a randomised study. Acta Anaesthesiol Scand. 2012 Sep;56(8):1013-9. doi: 10.1111/j.1399-6576.2012.02737.x. Epub 2012 Jul 26.
- Background: PubMed 17618402Tubbs RS, Loukas M, Shoja MM, Apaydin N, Oakes WJ, Salter EG. Anatomy and potential clinical significance of the vastoadductor membrane. Surg Radiol Anat. 2007 Oct;29(7):569-73. doi: 10.1007/s00276-007-0230-4. Epub 2007 Jul 7.
- Background: PubMed 23241723Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b.
- Background: PubMed 26079800Machi AT, Sztain JF, Kormylo NJ, Madison SJ, Abramson WB, Monahan AM, Khatibi B, Ball ST, Gonzales FB, Sessler DI, Mascha EJ, You J, Nakanote KA, Ilfeld BM. Discharge Readiness after Tricompartment Knee Arthroplasty: Adductor Canal versus Femoral Continuous Nerve Blocks-A Dual-center, Randomized Trial. Anesthesiology. 2015 Aug;123(2):444-56. doi: 10.1097/ALN.0000000000000741.
- Background: PubMed 24401769Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.
- Background: PubMed 24747312Bendtsen TF, Moriggl B, Chan V, Pedersen EM, Borglum J. Defining adductor canal block. Reg Anesth Pain Med. 2014 May-Jun;39(3):253-4. doi: 10.1097/AAP.0000000000000052. No abstract available.
- Background: PubMed 19920424Horn JL, Pitsch T, Salinas F, Benninger B. Anatomic basis to the ultrasound-guided approach for saphenous nerve blockade. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):486-9. doi: 10.1097/AAP.0b013e3181ae11af.
- Background: PubMed 25140514Bendtsen TF, Moriggl B, Chan V, Pedersen EM, Borglum J. Redefining the adductor canal block. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):442-3. doi: 10.1097/AAP.0000000000000119. No abstract available.
- Background: PubMed 24747313Jaeger P, Lund J, Jenstrup MT, Brondum V, Dahl JB. Reply to Dr Bendtsen. Reg Anesth Pain Med. 2014 May-Jun;39(3):254-5. doi: 10.1097/AAP.0000000000000069. No abstract available.
- Background: PubMed 25688724Cowlishaw P, Kotze P. Adductor canal block--or subsartorial canal block? Reg Anesth Pain Med. 2015 Mar-Apr;40(2):175-6. doi: 10.1097/AAP.0000000000000205. No abstract available.
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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.
Anthony Machi, MD principal investigator
University of Texas Southwestern Medical Center
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 Postoperative Pain, run by University of Texas Southwestern Medical Center 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 8 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 21 Apr 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 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?
Yes. Results are posted in the registry (first posted 21 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Grid Points With Change of Sensation to Pinprick After Blockade (time frame: 20 minutes). 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 NCT02788019, which also lists 22 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 Apr 2021.