A Phase 4 interventional study of Obturator nerve regional block and Adductor canal regional block in Knee Osteoarthritis and Knee Rheumatism, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-09-30.
Sponsored by Icahn School of Medicine at Mount Sinai · Phase 4, Interventional, and Treatment
Among 15 studies testing bupivacaine in Osteoarthritis, Knee — 1 open to participants now, 1 under way, none of them phase 3. Bupivacaine · Osteoarthritis, Knee.
Among the 15 studies testing bupivacaine in Osteoarthritis, Knee, this one is the 10th largest by enrollment, is the only one that started in 2017, is one of 5 in phase 4, and was the 9th registered.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's enrollment of 60 is below the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →1 of the 15 studies testing bupivacaine in Osteoarthritis, Knee is open now, in 1 country. Each count lists the studies.
Bupivacaine: first FDA approval 1972 (MARCAINE HYDROCHLORIDE PRESERVATIVE FREE), first EMA approval 2020. What it is approved for, and how studies give it, is on its page →
Of the 382 Osteoarthritis, Knee studies recruiting now, 176 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →15 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 1 started in 2017.
Median enrollment 75 across the 15 interventional studies. Of the 9 that completed or were terminated, 5 (56%) have results posted.
1 of 15 have an industry lead sponsor. The 10 most frequent:
Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
Icahn School of Medicine at Mount Sinai has 2 studies filed under Osteoarthritis, Knee — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 15 studies testing bupivacaine in Osteoarthritis, Knee, from their registry updates:
Nothing recorded among them since 2026-09-25.
One common anesthetic that is performed for total knee replacement surgery is spinal anesthesia with an adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control after surgery. The aim of this study is to determine whether the addition of another regional block called obturator nerve block, which involves injecting numbing medication in the upper thigh region, will improve pain control after surgery while not sacrificing mobility after surgery.
There is currently no consensus on the optimal strategy that provides the most effective postoperative analgesia while preserving ambulation and limiting side effects such as nausea and vomiting. The clinical team's hypothesis is that the obturator nerve block in addition to adductor canal block can target both the anterior and posterior distribution of nerves to the knee to provide superior analgesia while not limiting ambulation. To test this hypothesis, the clinical team will compare the rate of IV opioid consumption in patients who receive a combination of adductor canal block and obturator nerve block at the surgical site versus patients who receive adductor canal block alone.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine
Drug: Obturator nerve regional block · Drug: Adductor canal regional block
Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with saline
Drug: Adductor canal regional block · Drug: Saline
Obturator nerve regional block involves the injection of a local anesthetic called bupivacaine into the upper thigh.
Also known as: bupivacaine
Adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control.
Saline as placebo comparator
Morphine Equivalence Consumption
Total amount of opioids consumed
Time frame: up to 24 hours after surgery
Pain Score
Likert scale ranging from 0-10 - 0 being no pain, and 10 being the worst pain ever experienced
Time frame: 1, 6, 12, and 24 hours after surgery
Number of Participants With Nausea or Vomiting
Yes or No responses when the subject is asked if the subject is feeling nauseous or has vomited
Time frame: up to 24 hours after surgery
Time to Ambulation
The length of time that it takes before the patient is first able to walk with assistance after surgery as assessed by a physical therapist.
Time frame: on postoperative day 1 after surgery
Time to Breakthrough Pain Medication
Time before pain medication needed for breakthrough pain
Time frame: up to post operative day 2 after surgery
Analgesia Satisfaction Score
Analgesia Satisfaction Score - Full scale from 0-10 with higher score indicating higher satisfaction.
Time frame: 2 weeks after surgery
Recruitment began in October with enrollment from December 2017 through December 2018.
| Milestone | Investigational Arm | Control Arm |
|---|---|---|
| Started | 30 | 30 |
| Completed | 30 | 30 |
| Not completed | 0 | 0 |
Total amount of opioids consumed
| MME | Bupivacaine Arm | Saline Control Arm |
|---|---|---|
| Morphine Equivalence Consumption | 12.6 ± 6.37 | 18.85 ± 7.74 |
Likert scale ranging from 0-10 - 0 being no pain, and 10 being the worst pain ever experienced
| score on a scale | Bupivacaine Arm | Saline Control Arm |
|---|---|---|
| 1 hour | 0.17 ± 0.64 | 0.23 ± 1.28 |
| 6 hours | 2.27 ± 2.82 | 2.77 ± 2.71 |
| 12 hours | 4.10 ± 2.92 | 5.13 ± 2.22 |
| 24 hours | 6.10 ± 2.66 | 7.00 ± 2.24 |
Yes or No responses when the subject is asked if the subject is feeling nauseous or has vomited
| Participants | Bupivacaine Arm | Saline Control Arm |
|---|---|---|
| Number of Participants With Nausea or Vomiting | 11 | 16 |
The length of time that it takes before the patient is first able to walk with assistance after surgery as assessed by a physical therapist.
| hours | Bupivacaine Arm | Saline Control Arm |
|---|---|---|
| Time to Ambulation | 8.98 ± 8.13 | 7.87 ± 8.49 |
Time before pain medication needed for breakthrough pain
| minutes | Bupivacaine Arm | Saline Control Arm |
|---|---|---|
| Time to Breakthrough Pain Medication | 872.54 ± 1044.07 | 510.13 ± 420.69 |
Analgesia Satisfaction Score - Full scale from 0-10 with higher score indicating higher satisfaction.
| score on a scale | Bupivacaine Arm | Saline Control Arm |
|---|---|---|
| Analgesia Satisfaction Score | 9.24 ± 0.93 | 8.59 ± 2.08 |
Collected over 2 weeks post surgery. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Investigational Arm | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Control Arm | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Continuous(years) | Bupivacaine Arm | Saline Control Arm | Total |
|---|---|---|---|
| Mean | 67.9 ± 7.5 | 66.7 ± 7.3 | 67.3 ± 7.4 |
| Sex: Female, Male(Participants) | Bupivacaine Arm | Saline Control Arm | Total |
|---|---|---|---|
| Female | 17 | 18 | 35 |
| Male | 13 | 12 | 25 |
| Race (NIH/OMB)(Participants) | Bupivacaine Arm | Saline Control Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 7 | 11 |
| White | 18 | 18 | 36 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 8 | 5 | 13 |
| Body Mass Index (BMI)(kg/m^2) | Bupivacaine Arm | Saline Control Arm | Total |
|---|---|---|---|
| Mean | 30.72 ± 4.85 | 28.65 ± 5.05 | 29.68 ± 5.02 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Bupivacaine
Icahn School of Medicine at Mount Sinai →