Injection Pressure & Adductor Canal Block

Not Applicable

Terminated

• Conditions: Injury of Anterior Cruciate Ligament; Orthopedic Disorders
• Interventions: Procedure: High Pressure Injection; Procedure: Low Pressure Injection

• Registration Number: NCT02563990
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-09-25
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-30
• Study Start: 2015-12-03
• Primary Completion: 2016-11-09
• Study Completion: 2016-12-09
• Results First Submitted: 2019-12-11
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-06
• Last Update Submitted: 2020-01-06
• Results First Posted: 2020-01-13
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Pressure	High Pressure Injection	High pressure injection of Ropivacaine local anesthetic at greater than 20 psi
Low Pressure	Low Pressure Injection	Low pressure injection of Ropivacaine local anesthetic at less than 15 psi

Primary Outcome Measures

Name	Time	Method
Spread of Injectate	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

Name	Time	Method
Number of Events of Sciatic Nerve Block 30 Minutes After Block Placement	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 sciatic nerve block will be recorded.
Postoperative Physical Therapy Milestone Achievement	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 (0-80 score range, where 0 is complete disability and 80 is fully functional).
Opioid Administration	day 1	Intraoperative and immediate postoperative opioid administration. Calculated as morphine milliequivalent (in milligrams).
Number of Events of Femoral Nerve Block 30 Minutes After Block Placement	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.
Postoperative Pain Scores (Numeric Rating Scale, 0-10)	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.

Trial Locations

Locations (1)

University of Miami Hospital; 🇺🇸 Miami, Florida, United States