Trial Outcomes & Findings for Ultrasound Guided Adductor Canal Versus Femoral Nerve Blocks for Anterior Cruciate Ligament Reconstruction in Pediatrics (NCT NCT03053401)

Last Updated: 2020-12-28

Results Overview

Measuring the quadriceps muscle strength (surgical side) using a dynamometer.Patients were placed supine with a cushion underneath their knee, resulting in a 45-degree angle at the knee. A dynamometer was placed on the anterior of the ankle, between the malleoli. Patients were instructed to extend their legs three times each, with a 30-s pause between each attempt (Lafayette Manual Muscle Test System; Lafayette Instrument Company, Lafayette, IN; and all three dynamometer readings in Kgf unit for each leg were recorded.Kgf is a gravitational metric unit force ,it is equal to the magnitude of the force exerted on one kilogram of mass under standard gravity.

Recruitment status

COMPLETED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

4 hours following peripheral nerve block performance

Results posted on

2020-12-28

Participant Flow

Potential subjects will be seen in the orthopedic office prior to the scheduled surgery. An informed consent will be provided for review by the authorized legal representative (s). If they agree to participate in the study, they will be requested to sign and date the informed consent.Patient ascent to the study may be also requested if needed.

Participant milestones

Participant milestones
Measure	Adductor Canal Block Adductor Canal Block performed at mid-thigh level to block the saphenous nerve under guidance of a linear ultrasound transducer probe (General Electric; GE). Performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg ( maximum of 40 mg ).	Femoral Nerve Block Femoral Nerve Block performed under guidance of a linear ultrasound transducer probe (General Electric;GE).Block will be performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg (maximum of 40 mg ).
Overall Study STARTED	26	26
Overall Study COMPLETED	26	26
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	Adductor Canal Block n=26 Participants Adductor Canal Block performed at mid-thigh level to block the saphenous nerve under guidance of a linear ultrasound transducer probe (General Electric; GE). Performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg ( maximum of 40 mg ).	Femoral Nerve Block n=26 Participants Femoral Nerve Block performed under guidance of a linear ultrasound transducer probe (General Electric;GE).Block will be performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg (maximum of 40 mg ). .	Total n=52 Participants Total of all reporting groups
Age, Categorical <=18 years	26 Participants n=26 Participants	26 Participants n=26 Participants	52 Participants n=52 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=26 Participants	0 Participants n=26 Participants	0 Participants n=52 Participants
Age, Categorical >=65 years	0 Participants n=26 Participants	0 Participants n=26 Participants	0 Participants n=52 Participants
Age, Continuous	15.8 years STANDARD_DEVIATION 1.5 • n=26 Participants	15.2 years STANDARD_DEVIATION 2.0 • n=26 Participants	15.5 years STANDARD_DEVIATION 1.7 • n=52 Participants
Sex: Female, Male Female	16 Participants n=26 Participants	15 Participants n=26 Participants	31 Participants n=52 Participants
Sex: Female, Male Male	10 Participants n=26 Participants	11 Participants n=26 Participants	21 Participants n=52 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	26 participants n=26 Participants	26 participants n=26 Participants	52 participants n=52 Participants
Pre-Surgical Quadriceps Muscle Strength	18.4 kgf n=26 Participants	19.0 kgf n=26 Participants	18.8 kgf n=52 Participants

PRIMARY outcome

Timeframe: 4 hours following peripheral nerve block performance

Population: 20 of 26 subjects in the femoral nerve block group had recorded quadriceps muscle strength of zero.

Outcome measures

Outcome measures
Measure	Adductor Canal Block n=26 Participants Adductor Canal Block performed at mid-thigh level to block the saphenous nerve under guidance of a linear ultrasound transducer probe (General Electric; GE). Performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg ( maximum of 40 mg ). .	Femoral Nerve Block n=26 Participants Femoral Nerve Block performed under guidance of a linear ultrasound transducer probe (General Electric;GE).Block will be performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg (maximum of 40 mg ).
Quadriceps Muscle Strength in Kilogram-force (Kgf)	1.1 Kilogram-force (Kgf) Interval 0.0 to 25.6	0.0 Kilogram-force (Kgf) Interval 0.0 to 15.3

PRIMARY outcome

Timeframe: 4 hours and 24 hours

Assessed by Numeric Scale (NS) pain scoring system. Minimum 0 and maximum 10 . Higher scores means worse outcome (pain)

Outcome measures

Outcome measures
Measure	Adductor Canal Block n=26 Participants Adductor Canal Block performed at mid-thigh level to block the saphenous nerve under guidance of a linear ultrasound transducer probe (General Electric; GE). Performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg ( maximum of 40 mg ). .	Femoral Nerve Block n=26 Participants Femoral Nerve Block performed under guidance of a linear ultrasound transducer probe (General Electric;GE).Block will be performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg (maximum of 40 mg ).
Post-operative Pain Scores Using the Numeric Pain Scoring System (NS) 4 hours post block	4.5 score on a scale Interval 2.0 to 5.0	4.5 score on a scale Interval 4.0 to 6.0
Post-operative Pain Scores Using the Numeric Pain Scoring System (NS) 24 hours post block	5.0 score on a scale Interval 3.0 to 7.0	6.0 score on a scale Interval 5.0 to 7.0

PRIMARY outcome

Timeframe: 24 hours following peripheral nerve block performance.

Total intravenous morphine/morphine equivalent consumption in milligrams (mg) at 24 hours post-block

Outcome measures

Outcome measures
Measure	Adductor Canal Block n=26 Participants Adductor Canal Block performed at mid-thigh level to block the saphenous nerve under guidance of a linear ultrasound transducer probe (General Electric; GE). Performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg ( maximum of 40 mg ). .	Femoral Nerve Block n=26 Participants Femoral Nerve Block performed under guidance of a linear ultrasound transducer probe (General Electric;GE).Block will be performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg (maximum of 40 mg ).
Total Opioid Consumption at 24 Hours Post-block	28.9 milligrams Standard Deviation 9.0	26.9 milligrams Standard Deviation 9.4

Adverse Events

Adductor Canal Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Femoral Nerve Block

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

Dr. Rami Karroum

Akron Children's Hospital

Phone: 330-543-8823

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place