Trial Outcomes & Findings for Adductor Canal Block Versus Femoral Nerve Block for Total Knee Arthroplasty (NCT NCT03133481)

NCT ID: NCT03133481

Last Updated: 2019-01-16

Results Overview

Distance ambulated in feet from the end of surgery to 24 hours postoperatively

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 94 participants
• Primary outcome timeframe: Baseline up to 24 hours after the Anesthesia Record Stop Time
• Results posted on: 2019-01-16

Participant Flow

Participant milestones

Measure	Adductor Canal Nerve Block Participants will be randomized using block randomization. Adductor Canal Nerve Block: Adductor Canal never technique	Femoral Nerve Block Participants will be randomized using block randomization. Femoral Nerve Block: Traditional technique
Overall Study STARTED	45	49
Overall Study COMPLETED	45	45
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Measure	Adductor Canal Nerve Block Participants will be randomized using block randomization. Adductor Canal Nerve Block: Adductor Canal never technique	Femoral Nerve Block Participants will be randomized using block randomization. Femoral Nerve Block: Traditional technique
Overall Study FC Catheter fell out post operative day1	0	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Adductor Canal Nerve Block n=45 Participants Participants will be randomized using block randomization. Adductor Canal Nerve Block: Adductor Canal never technique	Femoral Nerve Block n=49 Participants Participants will be randomized using block randomization. Femoral Nerve Block: Traditional technique	Total n=94 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=45 Participants	0 Participants n=49 Participants	0 Participants n=94 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=45 Participants	21 Participants n=49 Participants	49 Participants n=94 Participants
Age, Categorical >=65 years	17 Participants n=45 Participants	28 Participants n=49 Participants	45 Participants n=94 Participants
Age, Continuous	63.4 years STANDARD_DEVIATION 10.01 • n=45 Participants	65.4 years STANDARD_DEVIATION 9.28 • n=49 Participants	64.4 years STANDARD_DEVIATION 9.65 • n=94 Participants
Sex: Female, Male Female	28 Participants n=45 Participants	31 Participants n=49 Participants	59 Participants n=94 Participants
Sex: Female, Male Male	17 Participants n=45 Participants	18 Participants n=49 Participants	35 Participants n=94 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	45 participants n=45 Participants	49 participants n=49 Participants	94 participants n=94 Participants

PRIMARY outcome

Timeframe: Baseline up to 24 hours after the Anesthesia Record Stop Time

Distance ambulated in feet from the end of surgery to 24 hours postoperatively

Outcome measures

Measure	Adductor Canal Nerve Block n=45 Participants Participants will be randomized using block randomization. Adductor Canal Nerve Block: Adductor Canal never technique	Femoral Nerve Block n=45 Participants Participants will be randomized using block randomization. Femoral Nerve Block: Traditional technique
Mean Distance Ambulated at 24 Hours Post Operatively	70.2 feet Standard Deviation 66.94	48.44 feet Standard Deviation 45.76

PRIMARY outcome

Timeframe: From the Anesthesia Record Stop Time to 48 hours after the Anesthesia Record Stop Time

Distance ambulated in feet from the end of surgery to 48 hours postoperatively

Outcome measures

Measure	Adductor Canal Nerve Block n=45 Participants Participants will be randomized using block randomization. Adductor Canal Nerve Block: Adductor Canal never technique	Femoral Nerve Block n=45 Participants Participants will be randomized using block randomization. Femoral Nerve Block: Traditional technique
Mean Distance Ambulated at 48 Hours Post Operatively	129.02 feet Standard Deviation 92.33	106.38 feet Standard Deviation 83.39

SECONDARY outcome

Timeframe: baseline up to time of anesthesia record start time

Visual Analog Scale (VAS) score immediately preoperatively.

The Visual Analog Scale is a standard numerical pain score reported by the patient, from 0-10, where 0=no pain, and 10=worst pain.

Outcome measures

Measure	Adductor Canal Nerve Block n=45 Participants Participants will be randomized using block randomization. Adductor Canal Nerve Block: Adductor Canal never technique	Femoral Nerve Block n=45 Participants Participants will be randomized using block randomization. Femoral Nerve Block: Traditional technique
Mean Pain Scores Immediately Preoperatively	3.07 score on a scale Standard Deviation 3.43	3.38 score on a scale Standard Deviation 3.44

SECONDARY outcome

Timeframe: from baseline to two hours

Preoperatively, opioid consumption will be measured from baseline to the Anesthesia Record Start Time in Oral Morphine Equivalents

Outcome measures

Measure	Adductor Canal Nerve Block n=45 Participants Participants will be randomized using block randomization. Adductor Canal Nerve Block: Adductor Canal never technique	Femoral Nerve Block n=45 Participants Participants will be randomized using block randomization. Femoral Nerve Block: Traditional technique
Mean Opioid Consumption as Measured by Oral Morphine Milligram Equivalents	23 Oral Morphine Milligram Equivalents Standard Deviation 8.52	22.33 Oral Morphine Milligram Equivalents Standard Deviation 8.23

SECONDARY outcome

Timeframe: Baseline up to 48 hrs

Patient satisfaction score, on an analog scale from 0-10, with 0 being the lowest satisfaction and 10 being the highest satisfaction.

Outcome measures

Measure	Adductor Canal Nerve Block n=45 Participants Participants will be randomized using block randomization. Adductor Canal Nerve Block: Adductor Canal never technique	Femoral Nerve Block n=45 Participants Participants will be randomized using block randomization. Femoral Nerve Block: Traditional technique
Patient Satisfaction at 48 Hours Post Operatively	8.71 score on a scale Standard Deviation 2.16	9.24 score on a scale Standard Deviation 1.26

SECONDARY outcome

Timeframe: Baseline to discharge (approximately 90 hrs)

Mean hours to discharge, from the time of admittance to the time of discharge

Outcome measures

Measure	Adductor Canal Nerve Block n=45 Participants Participants will be randomized using block randomization. Adductor Canal Nerve Block: Adductor Canal never technique	Femoral Nerve Block n=45 Participants Participants will be randomized using block randomization. Femoral Nerve Block: Traditional technique
Mean Hours to Discharge	89.66 hours Standard Deviation 32.24	83.78 hours Standard Deviation 14.52

SECONDARY outcome

Timeframe: Immediately post operatively, not more than 4 hours after pacu admittance

The Mean Pain Score (VAS) at no more than 4 hours after the Anesthesia Record Stop Time.

The Visual Analog Scale is a standard numerical pain score reported by the patient, from 0-10, where 0=no pain, and 10=worst pain.

Outcome measures

Measure	Adductor Canal Nerve Block n=45 Participants Participants will be randomized using block randomization. Adductor Canal Nerve Block: Adductor Canal never technique	Femoral Nerve Block n=45 Participants Participants will be randomized using block randomization. Femoral Nerve Block: Traditional technique
Mean Pain Scores in PACU	3.91 score on a scale Standard Deviation 3.19	2.98 score on a scale Standard Deviation 3.05

SECONDARY outcome

Timeframe: From the Anesthesia Record stop time to 24 hours after Anesthesia Record stop time

Visual Analog Scale (VAS) score at 24 hours from the time of Anesthesia Record Stop Time.

The Visual Analog Scale is a standard numerical pain score reported by the patient, from 0-10, where 0=no pain, and 10=worst pain.

Outcome measures

Measure	Adductor Canal Nerve Block n=45 Participants Participants will be randomized using block randomization. Adductor Canal Nerve Block: Adductor Canal never technique	Femoral Nerve Block n=45 Participants Participants will be randomized using block randomization. Femoral Nerve Block: Traditional technique
Mean Pain Scores at 24 Hours	4.18 score on a scale Standard Deviation 2.64	4 score on a scale Standard Deviation 2.35

SECONDARY outcome

Timeframe: From the Anesthesia Record Stop Time to 48 hours from the Anesthesia Record Stop Time

Visual Analog Scale (VAS) score at 48 hours from the time of Anesthesia Record Stop Time.

The Visual Analog Scale is a standard numerical pain score reported by the patient, from 0-10, where 0=no pain, and 10=worst pain.

Outcome measures

Measure	Adductor Canal Nerve Block n=45 Participants Participants will be randomized using block randomization. Adductor Canal Nerve Block: Adductor Canal never technique	Femoral Nerve Block n=45 Participants Participants will be randomized using block randomization. Femoral Nerve Block: Traditional technique
Mean Pain Scores 48 Hours Postoperatively	4.53 score on a scale Standard Deviation 2.37	4.44 score on a scale Standard Deviation 2.29

SECONDARY outcome

Timeframe: Post operatively through 4 hours

Mean opioid consumption as measured immediately post operatively from Anesthesia Record Stop Time to 4 hours after Anesthesia Record Stop Time in Oral Morphine Milligram Equivalents

Outcome measures

Measure	Adductor Canal Nerve Block n=45 Participants Participants will be randomized using block randomization. Adductor Canal Nerve Block: Adductor Canal never technique	Femoral Nerve Block n=45 Participants Participants will be randomized using block randomization. Femoral Nerve Block: Traditional technique
Mean Opioid Consumption as Measured in Oral Morphine Milligram Equivalents	53.92 Oral Morphine Milligram Equivalents Standard Deviation 34.56	50.77 Oral Morphine Milligram Equivalents Standard Deviation 32.99

SECONDARY outcome

Timeframe: From immediately post operatively through 24 hours

Mean opioid consumption as calculated from the time of Anesthesia Record Stop Time to 24 hours after Anesthesia Record Stop Time in Oral Morphine Equivalents

Outcome measures

Measure	Adductor Canal Nerve Block n=45 Participants Participants will be randomized using block randomization. Adductor Canal Nerve Block: Adductor Canal never technique	Femoral Nerve Block n=45 Participants Participants will be randomized using block randomization. Femoral Nerve Block: Traditional technique
Mean Opioid Consumption as Measured in Oral Morphine Milligram Equivalents	75.54 Oral Morphine Milligram Equivalents Standard Deviation 49.81	68.78 Oral Morphine Milligram Equivalents Standard Deviation 55.08

SECONDARY outcome

Timeframe: From immediately post operatively through 48 hours

Mean opioid consumption as calculated from Anesthesia Record Stop Time to 48 hours after Anesthesia Record Stop Time in Oral Morphine Milligram Equivalents

Outcome measures

Measure	Adductor Canal Nerve Block n=45 Participants Participants will be randomized using block randomization. Adductor Canal Nerve Block: Adductor Canal never technique	Femoral Nerve Block n=45 Participants Participants will be randomized using block randomization. Femoral Nerve Block: Traditional technique
Mean Opioid Consumption as Measured in Oral Morphine Equivalents	55.49 Oral Morphine Milligram Equivalents Standard Deviation 32.3	44.47 Oral Morphine Milligram Equivalents Standard Deviation 22.26

Adverse Events

Adductor Canal Nerve 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

Adam Sturdivant

University of Alabama at Birmingham

Phone: 205-934-4042

Email: Adamsturdivant@uabmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place