Injection Pressure & Adductor Canal Block
Primary Purpose
Orthopedic Disorders, Injury of Anterior Cruciate Ligament
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Pressure Injection
Low Pressure Injection
Sponsored by
About this trial
This is an interventional prevention trial for Orthopedic Disorders
Eligibility Criteria
Inclusion criteria:
- Planned general anesthetic.
- American Society of Anesthesia classes I, II, or III.
- Patients aged 18-65.
- English-speaking patients.
Exclusion criteria:
- ASA classes IV and V.
- Patients younger than 18 or older than 65.
- Contraindication to regional anesthesia (coagulopathy, patient refusal).
- Allergy to local anesthetic or other study medications.
- BMI > 35 kg/m2.
- Chronic opioid use (daily or almost daily use for > 3 months).
- Active illicit drug use.
- Additional surgical site other than the limb for adductor canal block.
- Pregnancy.
- Preexisting neuropathy in the operative limb.
- Inability to communicate to investigators or hospital staff.
- Inability to speak or understand English.
Sites / Locations
- University of Miami Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High Pressure
Low Pressure
Arm Description
High pressure injection of Ropivacaine local anesthetic at greater than 20 psi
Low pressure injection of Ropivacaine local anesthetic at less than 15 psi
Outcomes
Primary Outcome Measures
Spread of Injectate
Our primary endpoint is the spread of injectate, defined as the distance between the uppermost and lowermost limits of spread of local anesthetic as assessed by ultrasound.
Secondary Outcome Measures
Number of Events of Femoral Nerve Block 30 Minutes After Block Placement
Sensory testing will use a pinprick method in the femoral (anterior thigh), saphenous (medial calf proximal to the medial malleolus, top of the patella) and sciatic (posterolateral calf, plantar surface of the foot) nerve distributions; if patients are unable to feel the stimulus in the femoral nerve distribution, then an outcome of a femoral nerve block will be recorded.
Number of Events of Sciatic Nerve Block 30 Minutes After Block Placement
Sensory testing will use a pinprick method in the femoral (anterior thigh), saphenous (medial calf proximal to the medial malleolus, top of the patella) and sciatic (posterolateral calf, plantar surface of the foot) nerve distributions; if patients are unable to feel the stimulus in the sciatic nerve distribution, then an outcome of a sciatic nerve block will be recorded.
Postoperative Pain Scores (Numeric Rating Scale, 0-10)
Patients will rate their pain after surgery on a scale from 0-10, with 0 being no pain, and 10 being the worst pain of their life.
Postoperative Physical Therapy Milestone Achievement
The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure (0-80 score range, where 0 is complete disability and 80 is fully functional).
Postoperative Physical Therapy Milestone Achievement
The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure (0-80 score range, where 0 is complete disability and 80 is fully functional).
Postoperative Physical Therapy Milestone Achievement
The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure (0-80 score range, where 0 is complete disability and 80 is fully functional).
Postoperative Physical Therapy Milestone Achievement
The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure (0-80 score range, where 0 is complete disability and 80 is fully functional).
Opioid Administration
Intraoperative and immediate postoperative opioid administration. Calculated as morphine milliequivalent (in milligrams).
Full Information
NCT ID
NCT02563990
First Posted
September 25, 2015
Last Updated
January 6, 2020
Sponsor
University of Miami
1. Study Identification
Unique Protocol Identification Number
NCT02563990
Brief Title
Injection Pressure & Adductor Canal Block
Official Title
The Impact of Injection Pressure During Adductor Canal Nerve Block
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit additional patients due to transfer of surgical service (ortho sports medicine) and recruitable cases to another institution.
Study Start Date
December 3, 2015 (Actual)
Primary Completion Date
November 9, 2016 (Actual)
Study Completion Date
December 9, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective, randomized, single-blinded human clinical trial that will examine how injection pressure influences the spread of a given volume of injectate in the adductor canal, during adductor canal nerve block.
Detailed Description
This is a prospective, randomized, single-blinded human clinical trial that will examine how injection pressure influences the spread of a given volume of injectate in the adductor canal, during adductor canal nerve block. The study population will be patients undergoing elective anterior cruciate ligament repair in the distal lower extremity and receiving preoperative adductor canal nerve blocks for postoperative analgesia. They will be randomized into two groups of 25 patients each. The investigators speculate that high injection pressures (>20 psi) will lead to greater spread of local anesthetic than low injection pressures (<15 psi) during mid-thigh adductor canal nerve blocks. The primary endpoint is the spread of injectate, defined as the distance between the uppermost and lowermost limits of spread of local anesthetic as assessed by ultrasound. The secondary endpoints are the incidence of femoral and sciatic nerve blocks 30 minutes after block placement, amount of IV opioid administered intraoperatively and postoperatively, preoperative and postoperative pain (Numeric Rating Scale, 0-10), and postoperative physical therapy milestone achievement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorders, Injury of Anterior Cruciate Ligament
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Pressure
Arm Type
Experimental
Arm Description
High pressure injection of Ropivacaine local anesthetic at greater than 20 psi
Arm Title
Low Pressure
Arm Type
Active Comparator
Arm Description
Low pressure injection of Ropivacaine local anesthetic at less than 15 psi
Intervention Type
Procedure
Intervention Name(s)
High Pressure Injection
Intervention Description
Adductor canal block performed at greater than 20 psi injection pressure
Intervention Type
Procedure
Intervention Name(s)
Low Pressure Injection
Intervention Description
Adductor canal block performed at less than 15 psi injection pressure
Primary Outcome Measure Information:
Title
Spread of Injectate
Description
Our primary endpoint is the spread of injectate, defined as the distance between the uppermost and lowermost limits of spread of local anesthetic as assessed by ultrasound.
Time Frame
Immediate post-procedure on day 1
Secondary Outcome Measure Information:
Title
Number of Events of Femoral Nerve Block 30 Minutes After Block Placement
Description
Sensory testing will use a pinprick method in the femoral (anterior thigh), saphenous (medial calf proximal to the medial malleolus, top of the patella) and sciatic (posterolateral calf, plantar surface of the foot) nerve distributions; if patients are unable to feel the stimulus in the femoral nerve distribution, then an outcome of a femoral nerve block will be recorded.
Time Frame
post-procedure and postoperative on day 1
Title
Number of Events of Sciatic Nerve Block 30 Minutes After Block Placement
Description
Sensory testing will use a pinprick method in the femoral (anterior thigh), saphenous (medial calf proximal to the medial malleolus, top of the patella) and sciatic (posterolateral calf, plantar surface of the foot) nerve distributions; if patients are unable to feel the stimulus in the sciatic nerve distribution, then an outcome of a sciatic nerve block will be recorded.
Time Frame
post-procedure and postoperative on day 1
Title
Postoperative Pain Scores (Numeric Rating Scale, 0-10)
Description
Patients will rate their pain after surgery on a scale from 0-10, with 0 being no pain, and 10 being the worst pain of their life.
Time Frame
postoperative on day 1
Title
Postoperative Physical Therapy Milestone Achievement
Description
The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure (0-80 score range, where 0 is complete disability and 80 is fully functional).
Time Frame
postoperative week 1
Title
Postoperative Physical Therapy Milestone Achievement
Description
The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure (0-80 score range, where 0 is complete disability and 80 is fully functional).
Time Frame
postoperative week 2
Title
Postoperative Physical Therapy Milestone Achievement
Description
The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure (0-80 score range, where 0 is complete disability and 80 is fully functional).
Time Frame
postoperative week 3
Title
Postoperative Physical Therapy Milestone Achievement
Description
The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure (0-80 score range, where 0 is complete disability and 80 is fully functional).
Time Frame
postoperative week 4
Title
Opioid Administration
Description
Intraoperative and immediate postoperative opioid administration. Calculated as morphine milliequivalent (in milligrams).
Time Frame
day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Planned general anesthetic.
American Society of Anesthesia classes I, II, or III.
Patients aged 18-65.
English-speaking patients.
Exclusion criteria:
ASA classes IV and V.
Patients younger than 18 or older than 65.
Contraindication to regional anesthesia (coagulopathy, patient refusal).
Allergy to local anesthetic or other study medications.
BMI > 35 kg/m2.
Chronic opioid use (daily or almost daily use for > 3 months).
Active illicit drug use.
Additional surgical site other than the limb for adductor canal block.
Pregnancy.
Preexisting neuropathy in the operative limb.
Inability to communicate to investigators or hospital staff.
Inability to speak or understand English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andres Missair, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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