Back to resultsFemoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension
Primary Purpose
Tourniquet Hypertension, Intraoperative Hypertension, Total Ankle Arthroplasty
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Mepivacaine
Saline
Perifemoral Injection of Local Anesthetic
Perifemoral Injection of Local Anesthetic
Sponsored by
About this trial
This is an interventional supportive care trial for Tourniquet Hypertension focused on measuring Perifemoral, Tourniquet, Mepivacaine, Tourniquet Hypertension
Eligibility Criteria
Inclusion Criteria:
Patients that will be included in the study are English speaking 18-75 year old ASA 1-3 patients undergoing total ankle arthroplasty.
Exclusion Criteria:
- ASA 4 or 5
- Diagnosis of chronic pain
- Daily chronic opioid use (over 3 months of continuous opioid use).
- Inability to communicate pain scores or need for analgesia.
- Infection at the site of block placement
- Age under 18 years old or greater than 75 years old
- Pregnant women (as determined by standard of care day-of surgery urine bHCG)
- Intolerance/allergy to local anesthetics
- Weight <50 kg
- Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
- Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course
Sites / Locations
- Duke University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Mepivacaine Block Group
Saline Sham Group
Arm Description
Infiltration of local anesthetic (mepivacaine) above and beside the femoral artery through a perineural catheter.
Infiltration of salt water (saline) above and beside the femoral artery through a perineural catheter.
Outcomes
Primary Outcome Measures
Change in tourniquet hypertension as measured by systolic blood pressure
Infiltrating study drug to reverse intraoperative tourniquet hypertension
Secondary Outcome Measures
Pain Scores (NRS11)
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Opioid consumption
Perioperative opioid consumption as measured in oral morphine equivalents (OMEs)
Quadriceps motor function
Gross quadriceps motor function as measured by leg extension
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04454203
Brief Title
Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension
Official Title
Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 5, 2021 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this prospective randomized double-blind study is to determine if an ultrasound guided peri-arterial injection of local anesthetic (LA) superomedially the femoral artery via peripheral nerve catheter reverses ischemic hypertension associated with prolonged lower extremity tourniquet time.
Detailed Description
This is a research study to find out if injection of numbing medication by the large artery going down your leg will improve high blood pressure caused by the tourniquet.
Depending on whether you enroll in this study, you may receive an injection of local anesthetic (numbing medication) or saline (salt water) by your femoral artery (the large artery going down your leg). This is to see how this injection impacts your blood pressure during surgery as the surgeons use a tourniquet (device that squeezes your leg) to help decrease the bleeding during surgery. Oftentimes the tourniquet causes your blood pressure to go up, but the numbing medication may help return your blood pressure close to its normal level. The rest of your anesthesia care, including other nerve blocks and general anesthetic, will be the same as it would be without participating in the study. You will be enrolled in this study for 24 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourniquet Hypertension, Intraoperative Hypertension, Total Ankle Arthroplasty, Ankle Fusion
Keywords
Perifemoral, Tourniquet, Mepivacaine, Tourniquet Hypertension
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mepivacaine Block Group
Arm Type
Experimental
Arm Description
Infiltration of local anesthetic (mepivacaine) above and beside the femoral artery through a perineural catheter.
Arm Title
Saline Sham Group
Arm Type
Placebo Comparator
Arm Description
Infiltration of salt water (saline) above and beside the femoral artery through a perineural catheter.
Intervention Type
Drug
Intervention Name(s)
Mepivacaine
Other Intervention Name(s)
Carbocaine
Intervention Description
An infiltration of mepivacaine superomedially to the femoral artery via perineural catheter.
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Salt water placebo
Intervention Description
An infiltration of saline superomedially to the femoral artery via perineural catheter.
Intervention Type
Procedure
Intervention Name(s)
Perifemoral Injection of Local Anesthetic
Other Intervention Name(s)
Femoral Periarterial Injection
Intervention Description
Infiltration of mepivacaine superomedially to the formal artery via perineural catheter in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.
Intervention Type
Procedure
Intervention Name(s)
Perifemoral Injection of Local Anesthetic
Other Intervention Name(s)
Femoral Periarterial Injection
Intervention Description
Infiltration of saline superomedially to the formal artery via perineural catheter that should NOT numb the nerves that contribute to tourniquet hypertension intraoperatively.
Primary Outcome Measure Information:
Title
Change in tourniquet hypertension as measured by systolic blood pressure
Description
Infiltrating study drug to reverse intraoperative tourniquet hypertension
Time Frame
From time of injection to 30 minutes after injection
Secondary Outcome Measure Information:
Title
Pain Scores (NRS11)
Description
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Time Frame
Perioperative start until 2 hours after admission to PACU
Title
Opioid consumption
Description
Perioperative opioid consumption as measured in oral morphine equivalents (OMEs)
Time Frame
Perioperative start until 2 hours after admission to PACU
Title
Quadriceps motor function
Description
Gross quadriceps motor function as measured by leg extension
Time Frame
1 hour after extubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients that will be included in the study are English speaking 18-75 year old ASA 1-3 patients undergoing total ankle arthroplasty.
Exclusion Criteria:
ASA 4 or 5
Diagnosis of chronic pain
Daily chronic opioid use (over 3 months of continuous opioid use).
Inability to communicate pain scores or need for analgesia.
Infection at the site of block placement
Age under 18 years old or greater than 75 years old
Pregnant women (as determined by standard of care day-of surgery urine bHCG)
Intolerance/allergy to local anesthetics
Weight <50 kg
Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
William M Bullock, MD, PhD
Phone
919-681-6437
Email
william.bullock@duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jeff C Gadsden, MD
Phone
919-681-6437
Email
jeff.gadsden@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Kumar, MD, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William M Bullock, MD, PhD
Organizational Affiliation
Duke University
Official's Role
Study Director
Facility Information:
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William M Bullock, MD, PhD
Phone
919-681-6437
Email
william.bullock@duke.edu
First Name & Middle Initial & Last Name & Degree
Amanda Kumar, MD
Phone
919-681-6437
Email
amanda.kumar@duke.edu
First Name & Middle Initial & Last Name & Degree
Amanda Kumar, MD
First Name & Middle Initial & Last Name & Degree
William M Bullock, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jeff C Gadsden, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.
Learn more about this trial
Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension
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