Trial Outcomes & Findings for Injection Pressure & Adductor Canal Block (NCT NCT02563990)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

Immediate post-procedure on day 1

Results posted on

2020-01-13

Participant Flow

Participant milestones

Participant milestones
Measure	High Pressure High pressure injection of Ropivacaine local anesthetic at greater than 20 psi High Pressure Injection: Adductor canal block performed at greater than 20 psi injection pressure High Pressure Injection: Ropivacaine 0.2% injection at greater than 20 psi injection pressure	Low Pressure Low pressure injection of Ropivacaine local anesthetic at less than 15 psi Low Pressure Injection: Adductor canal block performed at less than 15 psi injection pressure Low Pressure Injection: Ropivacaine 0.2% injection at less than 15 psi injection pressure
Overall Study STARTED	12	14
Overall Study COMPLETED	12	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Pressure n=12 Participants High pressure injection of Ropivacaine local anesthetic at greater than 20 psi High Pressure Injection: Adductor canal block performed at greater than 20 psi injection pressure High Pressure Injection: Ropivacaine 0.2% injection at greater than 20 psi injection pressure	Low Pressure n=14 Participants Low pressure injection of Ropivacaine local anesthetic at less than 15 psi Low Pressure Injection: Adductor canal block performed at less than 15 psi injection pressure Low Pressure Injection: Ropivacaine 0.2% injection at less than 15 psi injection pressure	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=12 Participants	0 Participants n=14 Participants	0 Participants n=26 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=12 Participants	14 Participants n=14 Participants	26 Participants n=26 Participants
Age, Categorical >=65 years	0 Participants n=12 Participants	0 Participants n=14 Participants	0 Participants n=26 Participants
Sex: Female, Male Female	7 Participants n=12 Participants	4 Participants n=14 Participants	11 Participants n=26 Participants
Sex: Female, Male Male	5 Participants n=12 Participants	10 Participants n=14 Participants	15 Participants n=26 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	High Pressure n=12 Participants High pressure injection of Ropivacaine local anesthetic at greater than 20 psi High Pressure Injection: Adductor canal block performed at greater than 20 psi injection pressure High Pressure Injection: Ropivacaine 0.2% injection at greater than 20 psi injection pressure	Low Pressure n=14 Participants Low pressure injection of Ropivacaine local anesthetic at less than 15 psi Low Pressure Injection: Adductor canal block performed at less than 15 psi injection pressure Low Pressure Injection: Ropivacaine 0.2% injection at less than 15 psi injection pressure
Spread of Injectate	18.5 cm Interval 8.5 to 29.0	10 cm Interval 2.0 to 16.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	High Pressure n=12 Participants High pressure injection of Ropivacaine local anesthetic at greater than 20 psi High Pressure Injection: Adductor canal block performed at greater than 20 psi injection pressure High Pressure Injection: Ropivacaine 0.2% injection at greater than 20 psi injection pressure	Low Pressure n=14 Participants Low pressure injection of Ropivacaine local anesthetic at less than 15 psi Low Pressure Injection: Adductor canal block performed at less than 15 psi injection pressure Low Pressure Injection: Ropivacaine 0.2% injection at less than 15 psi injection pressure
Number of Events of Femoral Nerve Block 30 Minutes After Block Placement	0 Events	0 Events

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	High Pressure n=12 Participants High pressure injection of Ropivacaine local anesthetic at greater than 20 psi High Pressure Injection: Adductor canal block performed at greater than 20 psi injection pressure High Pressure Injection: Ropivacaine 0.2% injection at greater than 20 psi injection pressure	Low Pressure n=14 Participants Low pressure injection of Ropivacaine local anesthetic at less than 15 psi Low Pressure Injection: Adductor canal block performed at less than 15 psi injection pressure Low Pressure Injection: Ropivacaine 0.2% injection at less than 15 psi injection pressure
Number of Events of Sciatic Nerve Block 30 Minutes After Block Placement	0 Events	0 Events

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	High Pressure n=12 Participants High pressure injection of Ropivacaine local anesthetic at greater than 20 psi High Pressure Injection: Adductor canal block performed at greater than 20 psi injection pressure High Pressure Injection: Ropivacaine 0.2% injection at greater than 20 psi injection pressure	Low Pressure n=14 Participants Low pressure injection of Ropivacaine local anesthetic at less than 15 psi Low Pressure Injection: Adductor canal block performed at less than 15 psi injection pressure Low Pressure Injection: Ropivacaine 0.2% injection at less than 15 psi injection pressure
Postoperative Pain Scores (Numeric Rating Scale, 0-10)	3 score on a scale Interval 2.0 to 3.0	4 score on a scale Interval 3.25 to 5.75

SECONDARY outcome

Timeframe: 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 (0-80 score range, where 0 is complete disability and 80 is fully functional).

Outcome measures

Outcome measures
Measure	High Pressure n=12 Participants High pressure injection of Ropivacaine local anesthetic at greater than 20 psi High Pressure Injection: Adductor canal block performed at greater than 20 psi injection pressure High Pressure Injection: Ropivacaine 0.2% injection at greater than 20 psi injection pressure	Low Pressure n=14 Participants Low pressure injection of Ropivacaine local anesthetic at less than 15 psi Low Pressure Injection: Adductor canal block performed at less than 15 psi injection pressure Low Pressure Injection: Ropivacaine 0.2% injection at less than 15 psi injection pressure
Postoperative Physical Therapy Milestone Achievement	47 score on a scale Interval 18.0 to 68.0	30 score on a scale Interval 8.0 to 55.0

SECONDARY outcome

Timeframe: 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 (0-80 score range, where 0 is complete disability and 80 is fully functional).

Outcome measures

Outcome measures
Measure	High Pressure n=12 Participants High pressure injection of Ropivacaine local anesthetic at greater than 20 psi High Pressure Injection: Adductor canal block performed at greater than 20 psi injection pressure High Pressure Injection: Ropivacaine 0.2% injection at greater than 20 psi injection pressure	Low Pressure n=14 Participants Low pressure injection of Ropivacaine local anesthetic at less than 15 psi Low Pressure Injection: Adductor canal block performed at less than 15 psi injection pressure Low Pressure Injection: Ropivacaine 0.2% injection at less than 15 psi injection pressure
Postoperative Physical Therapy Milestone Achievement	53 score on a scale Interval 32.0 to 75.0	50 score on a scale Interval 22.0 to 58.0

SECONDARY outcome

Timeframe: 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 (0-80 score range, where 0 is complete disability and 80 is fully functional).

Outcome measures

Outcome measures
Measure	High Pressure n=12 Participants High pressure injection of Ropivacaine local anesthetic at greater than 20 psi High Pressure Injection: Adductor canal block performed at greater than 20 psi injection pressure High Pressure Injection: Ropivacaine 0.2% injection at greater than 20 psi injection pressure	Low Pressure n=14 Participants Low pressure injection of Ropivacaine local anesthetic at less than 15 psi Low Pressure Injection: Adductor canal block performed at less than 15 psi injection pressure Low Pressure Injection: Ropivacaine 0.2% injection at less than 15 psi injection pressure
Postoperative Physical Therapy Milestone Achievement	60 score on a scale Interval 30.0 to 72.0	51 score on a scale Interval 40.0 to 70.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	High Pressure n=12 Participants High pressure injection of Ropivacaine local anesthetic at greater than 20 psi High Pressure Injection: Adductor canal block performed at greater than 20 psi injection pressure High Pressure Injection: Ropivacaine 0.2% injection at greater than 20 psi injection pressure	Low Pressure n=14 Participants Low pressure injection of Ropivacaine local anesthetic at less than 15 psi Low Pressure Injection: Adductor canal block performed at less than 15 psi injection pressure Low Pressure Injection: Ropivacaine 0.2% injection at less than 15 psi injection pressure
Postoperative Physical Therapy Milestone Achievement	70 score on a scale Interval 59.0 to 78.0	65 score on a scale Interval 20.0 to 69.0

SECONDARY outcome

Timeframe: day 1

Intraoperative and immediate postoperative opioid administration. Calculated as morphine milliequivalent (in milligrams).

Outcome measures

Outcome measures
Measure	High Pressure n=12 Participants High pressure injection of Ropivacaine local anesthetic at greater than 20 psi High Pressure Injection: Adductor canal block performed at greater than 20 psi injection pressure High Pressure Injection: Ropivacaine 0.2% injection at greater than 20 psi injection pressure	Low Pressure n=14 Participants Low pressure injection of Ropivacaine local anesthetic at less than 15 psi Low Pressure Injection: Adductor canal block performed at less than 15 psi injection pressure Low Pressure Injection: Ropivacaine 0.2% injection at less than 15 psi injection pressure
Opioid Administration	20.909 milligrams Standard Error 2.827	16.033 milligrams Standard Error 2.438

Adverse Events

High Pressure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Pressure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andres Missair

University of Miami

Phone: 3055857037

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place