Injection Pressure & Adductor Canal Block

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-03

Study Completion Date

2016-12-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Orthopedic Disorders Injury of Anterior Cruciate Ligament

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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High Pressure

High pressure injection of Ropivacaine local anesthetic at greater than 20 psi

Group Type EXPERIMENTAL

High Pressure Injection

Intervention Type PROCEDURE

Adductor canal block performed at greater than 20 psi injection pressure

Low Pressure

Low pressure injection of Ropivacaine local anesthetic at less than 15 psi

Group Type ACTIVE_COMPARATOR

Low Pressure Injection

Intervention Type PROCEDURE

Adductor canal block performed at less than 15 psi injection pressure

Interventions

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High Pressure Injection

Adductor canal block performed at greater than 20 psi injection pressure

Intervention Type PROCEDURE

Low Pressure Injection

Adductor canal block performed at less than 15 psi injection pressure

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes