Clinical trial NCT02563990: Injection Pressure & Adductor Canal Block
Official title: The Impact of Injection Pressure During Adductor Canal Nerve Block
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Orthopedic Disorders
Injury of Anterior Cruciate Ligament
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Spread of Injectate
timeFrame: Immediate post-procedure on day 1
Secondary outcomes:
measure: Number of Events of Femoral Nerve Block 30 Minutes After Block Placement
timeFrame: post-procedure and postoperative on day 1
measure: Number of Events of Sciatic Nerve Block 30 Minutes After Block Placement
timeFrame: post-procedure and postoperative on day 1
measure: Postoperative Pain Scores (Numeric Rating Scale, 0-10)
timeFrame: postoperative on day 1
measure: Postoperative Physical Therapy Milestone Achievement
timeFrame: postoperative week 1
measure: Postoperative Physical Therapy Milestone Achievement
timeFrame: postoperative week 2
measure: Postoperative Physical Therapy Milestone Achievement
timeFrame: postoperative week 3
measure: Postoperative Physical Therapy Milestone Achievement
timeFrame: postoperative week 4
measure: Opioid Administration
timeFrame: day 1
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Andres Missair, MD
role: PRINCIPAL_INVESTIGATOR
References: