Injection Pressure & Adductor Canal Block

University of Miami

Status: Terminated

Conditions: Injury of Anterior Cruciate Ligament; Orthopedic Disorders

Treatments: Procedure: High Pressure Injection; Procedure: Low Pressure Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02563990

20150583

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

High Pressure

Experimental group

Description:

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

Treatment:

Procedure: High Pressure Injection

Low Pressure

Active Comparator group

Description:

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

Treatment:

Procedure: Low Pressure Injection