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Injection Pressure & Adductor Canal Block

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ClinicalTrials.gov Identifier: NCT02563990
Recruitment Status : Terminated (Unable to recruit additional patients due to transfer of surgical service (ortho sports medicine) and recruitable cases to another institution.)
First Posted : September 30, 2015
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Andres Missair, University of Miami

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.

Condition or disease Intervention/treatment Phase
Orthopedic Disorders Injury of Anterior Cruciate Ligament Procedure: High Pressure Injection Procedure: Low Pressure Injection Drug: High Pressure Injection Drug: Low Pressure Injection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Impact of Injection Pressure During Adductor Canal Nerve Block
Study Start Date : February 2016
Actual Primary Completion Date : January 8, 2019
Actual Study Completion Date : April 17, 2019

Arm Intervention/treatment
Experimental: High Pressure
High pressure injection of Ropivacaine local anesthetic at greater than 20 psi
Procedure: High Pressure Injection
Adductor canal block performed at greater than 20 psi injection pressure

Drug: High Pressure Injection
Ropivacaine 0.2% injection at greater than 20 psi injection pressure

Active Comparator: Low Pressure
Low pressure injection of Ropivacaine local anesthetic at less than 15 psi
Procedure: Low Pressure Injection
Adductor canal block performed at less than 15 psi injection pressure

Drug: Low Pressure Injection
Ropivacaine 0.2% injection at less than 15 psi injection pressure




Primary Outcome Measures :
  1. spread of injectate [ Time Frame: Immediate post-procedure on day 1 ]
    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 :
  1. incidence of femoral nerve block 30 minutes after block placement [ Time Frame: post-procedure and postoperative on day 1 ]
    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.

  2. incidence of sciatic nerve block 30 minutes after block placement [ Time Frame: post-procedure and postoperative on day 1 ]
    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 femoral nerve block will be recorded.

  3. preoperative pain scores (Numeric Rating Scale, 0-10) [ Time Frame: preoperative on day 1 ]
    Patients will be asked to rate their pain prior to surgery on a scale from 0-10, with 0 being no pain, and 10 being the worst pain of their life.

  4. postoperative pain scores (Numeric Rating Scale, 0-10) [ Time Frame: postoperative on day 1 ]
    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.

  5. postoperative physical therapy milestone achievement [ Time Frame: postoperative week 1 ]
    The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure.

  6. postoperative physical therapy milestone achievement [ Time Frame: postoperative week 2 ]
    The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure.

  7. postoperative physical therapy milestone achievement [ Time Frame: postoperative week 3 ]
    The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure.

  8. postoperative physical therapy milestone achievement [ Time Frame: postoperative week 4 ]
    The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Planned general anesthetic.
  2. American Society of Anesthesia classes I, II, or III.
  3. Patients aged 18-65.
  4. English-speaking patients.

Exclusion criteria:

  1. ASA classes IV and V.
  2. Patients younger than 18 or older than 65.
  3. Contraindication to regional anesthesia (coagulopathy, patient refusal).
  4. Allergy to local anesthetic or other study medications.
  5. BMI > 35 kg/m2.
  6. Chronic opioid use (daily or almost daily use for > 3 months).
  7. Active illicit drug use.
  8. Additional surgical site other than the limb for adductor canal block.
  9. Pregnancy.
  10. Preexisting neuropathy in the operative limb.
  11. Inability to communicate to investigators or hospital staff.
  12. Inability to speak or understand English.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563990


Locations
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United States, Florida
University of Miami Hospital
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami

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Responsible Party: Andres Missair, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02563990     History of Changes
Other Study ID Numbers: 20150583
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Musculoskeletal Diseases
Knee Injuries
Leg Injuries
Wounds and Injuries
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents