- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03326999
Does Adding an Additional Numbing Medication Injection in the Thigh Help With Pain Control After Knee Replacement Surgery?
September 10, 2020 updated by: Christina Jeng, Icahn School of Medicine at Mount Sinai
Evaluating the Addition of Obturator Nerve Block to Adductor Canal Block for Total Knee Arthroplasty
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients scheduled to undergo total knee arthroplasty
- Planned use of regional anesthesia for procedure
- Willing and able to provide informed consent
Exclusion Criteria:
- Patients on immunosuppressive therapy
- Patients with history of diabetes
- Patients with lower limb neuropathy
- Patients with history of chronic opioid use for > 3 months, including but not limited to, fentanyl, morphine, oxycodone, methadone
- Patients with known allergy or intolerance to any drug used in the study
- Patients with history of alcohol or drug abuse
- Patients with history of intolerance of nonsteroidal anti-inflammatory drugs
- Patients with hepatic or renal insufficiency
- ASA score of 4 or greater
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Investigational arm
Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine
|
Obturator nerve regional block involves the injection of a local anesthetic called bupivacaine into the upper thigh.
Other Names:
Adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control.
|
Sham Comparator: Control arm
Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with saline
|
Adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control.
Saline as placebo comparator
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morphine Equivalence Consumption
Time Frame: up to 24 hours after surgery
|
Total amount of opioids consumed
|
up to 24 hours after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Score
Time Frame: 1, 6, 12, and 24 hours after surgery
|
Likert scale ranging from 0-10 - 0 being no pain, and 10 being the worst pain ever experienced
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1, 6, 12, and 24 hours after surgery
|
Number of Participants With Nausea or Vomiting
Time Frame: up to 24 hours after surgery
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Yes or No responses when the subject is asked if the subject is feeling nauseous or has vomited
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up to 24 hours after surgery
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Time to Ambulation
Time Frame: on postoperative day 1 after surgery
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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.
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on postoperative day 1 after surgery
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Time to Breakthrough Pain Medication
Time Frame: up to post operative day 2 after surgery
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Time before pain medication needed for breakthrough pain
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up to post operative day 2 after surgery
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Analgesia Satisfaction Score
Time Frame: 2 weeks after surgery
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Analgesia Satisfaction Score - Full scale from 0-10 with higher score indicating higher satisfaction.
|
2 weeks after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 11, 2017
Primary Completion (Actual)
December 18, 2018
Study Completion (Actual)
December 18, 2018
Study Registration Dates
First Submitted
October 27, 2017
First Submitted That Met QC Criteria
October 27, 2017
First Posted (Actual)
October 31, 2017
Study Record Updates
Last Update Posted (Actual)
September 30, 2020
Last Update Submitted That Met QC Criteria
September 10, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 17-2153
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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