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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational arm | Experimental | Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine |
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| Control arm | Sham Comparator | Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with saline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obturator nerve regional block | Drug | Obturator nerve regional block involves the injection of a local anesthetic called bupivacaine into the upper thigh. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Equivalence Consumption | Total amount of opioids consumed | up to 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | Likert scale ranging from 0-10 - 0 being no pain, and 10 being the worst pain ever experienced | 1, 6, 12, and 24 hours after surgery |
| Number of Participants With Nausea or Vomiting |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Jeng, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27171822 | Background | Runge C, Borglum J, Jensen JM, Kobborg T, Pedersen A, Sandberg J, Mikkelsen LR, Vase M, Bendtsen TF. The Analgesic Effect of Obturator Nerve Block Added to a Femoral Triangle Block After Total Knee Arthroplasty: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):445-51. doi: 10.1097/AAP.0000000000000406. |
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Recruitment began in October with enrollment from December 2017 through December 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Arm | Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine |
| FG001 | Control Arm | Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with saline |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 29, 2017 | Aug 3, 2020 |
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Randomized controlled trial with two arms: one arm will receive adductor canal block and obturator nerve block with the local anesthetic bupivacaine; second arm will receive adductor canal block with bupivacaine and obturator nerve block with saline.
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| Adductor canal regional block | Drug | Adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control. |
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| Saline | Drug | Saline as placebo comparator |
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Yes or No responses when the subject is asked if the subject is feeling nauseous or has vomited
| 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. | on postoperative day 1 after surgery |
| Time to Breakthrough Pain Medication | Time before pain medication needed for breakthrough pain | 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. | 2 weeks after surgery |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupivacaine Arm | Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine |
| BG001 | Saline Control Arm | Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with saline |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Morphine Equivalence Consumption | Total amount of opioids consumed | Posted | Mean | Standard Deviation | MME | up to 24 hours after surgery |
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| Secondary | Pain Score | Likert scale ranging from 0-10 - 0 being no pain, and 10 being the worst pain ever experienced | Posted | Mean | Standard Deviation | score on a scale | 1, 6, 12, and 24 hours after surgery |
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| Secondary | 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 | Posted | Count of Participants | Participants | up to 24 hours after surgery |
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| Secondary | 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. | Posted | Mean | Standard Deviation | hours | on postoperative day 1 after surgery |
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| Secondary | Time to Breakthrough Pain Medication | Time before pain medication needed for breakthrough pain | Posted | Mean | Standard Deviation | minutes | up to post operative day 2 after surgery |
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| Secondary | Analgesia Satisfaction Score | Analgesia Satisfaction Score - Full scale from 0-10 with higher score indicating higher satisfaction. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks after surgery |
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2 weeks post surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Investigational Arm | Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine | 0 | 30 | 0 | 30 | 0 | 30 |
| EG001 | Control Arm | Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with saline | 0 | 30 | 0 | 30 | 0 | 30 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christina Jeng | Icahn School of Medicine at Mount Sinai | 212-241-6426 | christina.jeng@mountsinai.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 29, 2017 | Aug 7, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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