Trial Outcomes & Findings for Femoral Versus Adductor Canal Continuous Peripheral Nerve Blocks for Knee Arthroplasty (NCT NCT01759277)

Results Overview

Discharge readiness is the number of hours until meeting the following 4 criteria: (1) adequate analgesia (defined as pain less than 4 on a NRS of 0-10); (2) independence from intravenous analgesics; (3) ability to ambulate 30 m and (4) ability to stand, walk 3 m, and return to a sitting position without another's assistance.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

80 participants

Primary outcome timeframe

7 postoperative days

Results posted on

2021-02-18

Participant Flow

Participant milestones

Participant milestones
Measure	Control Femoral perineural local anesthetic infusion Active comparator: Control: Femoral perineural local anesthetic infusion: The control group will receive a femoral nerve catheter and block under ultrasound guidance with the final position of catheter posterior to the femoral nerve and lateral to the femoral artery. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic.	Experimental Adductor canal perineural local anesthetic infusion Experimental: Adductor Canal perineural local anesthetic infusion: The experimental group will receive an adductor canal catheter and block under ultrasound guidance with the final position of catheter between the femoral artery and nerve. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic.
Overall Study STARTED	41	39
Overall Study COMPLETED	41	39
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	Control n=41 Participants Femoral perineural local anesthetic infusion Active comparator: Control: Femoral perineural local anesthetic infusion: The control group will receive a femoral nerve catheter and block under ultrasound guidance with the final position of catheter posterior to the femoral nerve and lateral to the femoral artery. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic.	Experimental n=39 Participants Adductor canal perineural local anesthetic infusion Experimental: Adductor Canal perineural local anesthetic infusion: The experimental group will receive an adductor canal catheter and block under ultrasound guidance with the final position of catheter between the femoral artery and nerve. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic.	Total n=80 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 7 • n=41 Participants	67 years STANDARD_DEVIATION 8 • n=39 Participants	66 years STANDARD_DEVIATION 8 • n=80 Participants
Sex: Female, Male Female	27 Participants n=41 Participants	23 Participants n=39 Participants	50 Participants n=80 Participants
Sex: Female, Male Male	14 Participants n=41 Participants	16 Participants n=39 Participants	30 Participants n=80 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Height	168 cm STANDARD_DEVIATION 10 • n=41 Participants	169 cm STANDARD_DEVIATION 11 • n=39 Participants	169 cm STANDARD_DEVIATION 11 • n=80 Participants
Weight	84 kg STANDARD_DEVIATION 16 • n=41 Participants	87 kg STANDARD_DEVIATION 16 • n=39 Participants	86 kg STANDARD_DEVIATION 17 • n=80 Participants
Body Mass Index	29 kg/m2 STANDARD_DEVIATION 5 • n=41 Participants	30 kg/m2 STANDARD_DEVIATION 5 • n=39 Participants	30 kg/m2 STANDARD_DEVIATION 5 • n=80 Participants

PRIMARY outcome

Timeframe: 7 postoperative days

Discharge readiness is the number of hours until meeting the following 4 criteria: (1) adequate analgesia (defined as pain less than 4 on a NRS of 0-10); (2) independence from intravenous analgesics; (3) ability to ambulate 30 m and (4) ability to stand, walk 3 m, and return to a sitting position without another's assistance.

Outcome measures

Outcome measures
Measure	Control n=41 Participants Femoral perineural local anesthetic infusion Active comparator: Control: Femoral perineural local anesthetic infusion: The control group will receive a femoral nerve catheter and block under ultrasound guidance with the final position of catheter posterior to the femoral nerve and lateral to the femoral artery. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic.	Experimental n=39 Participants Adductor canal perineural local anesthetic infusion Experimental: Adductor Canal perineural local anesthetic infusion: The experimental group will receive an adductor canal catheter and block under ultrasound guidance with the final position of catheter between the femoral artery and nerve. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic.
Hours Until Discharge Readiness	61 hours Interval 49.0 to 69.0	55 hours Interval 42.0 to 63.0

SECONDARY outcome

Timeframe: First 7 postoperative days

The time in hours until adequate analgesia is defined as pain less than 4 on a Numeric Rating Scale of 0-10, with 0=no pain and 10=worst imaginable pain

Outcome measures

Outcome measures
Measure	Control n=41 Participants Femoral perineural local anesthetic infusion Active comparator: Control: Femoral perineural local anesthetic infusion: The control group will receive a femoral nerve catheter and block under ultrasound guidance with the final position of catheter posterior to the femoral nerve and lateral to the femoral artery. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic.	Experimental n=39 Participants Adductor canal perineural local anesthetic infusion Experimental: Adductor Canal perineural local anesthetic infusion: The experimental group will receive an adductor canal catheter and block under ultrasound guidance with the final position of catheter between the femoral artery and nerve. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic.
Time to Adequate Analgesia	61.6 Hours Standard Deviation 20.2	61.0 Hours Standard Deviation 19.3

SECONDARY outcome

Timeframe: First 7 postoperative days

The time in hours until no intravenous analgesics were required for at least 12 hours (without future intravenous use during admission)

Outcome measures

Outcome measures
Measure	Control n=41 Participants Femoral perineural local anesthetic infusion Active comparator: Control: Femoral perineural local anesthetic infusion: The control group will receive a femoral nerve catheter and block under ultrasound guidance with the final position of catheter posterior to the femoral nerve and lateral to the femoral artery. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic.	Experimental n=39 Participants Adductor canal perineural local anesthetic infusion Experimental: Adductor Canal perineural local anesthetic infusion: The experimental group will receive an adductor canal catheter and block under ultrasound guidance with the final position of catheter between the femoral artery and nerve. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic.
Time Until Independence From Intravenous Analgesics of at Least 12 Hours	46.1 Hours Standard Deviation 20.1	47.5 Hours Standard Deviation 22.7

SECONDARY outcome

Timeframe: Hours

The timed-up-and-go (TUG) test measures the ability and speed of standing from a sitting position, walking 3 meters and returning to the original seated position independent from the assistance of healthcare personnel. This variable measured the time in hours until the patient could successfully achieve this test independently, regardless of the amount of time required.

Outcome measures

Outcome measures
Measure	Control n=41 Participants Femoral perineural local anesthetic infusion Active comparator: Control: Femoral perineural local anesthetic infusion: The control group will receive a femoral nerve catheter and block under ultrasound guidance with the final position of catheter posterior to the femoral nerve and lateral to the femoral artery. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic.	Experimental n=39 Participants Adductor canal perineural local anesthetic infusion Experimental: Adductor Canal perineural local anesthetic infusion: The experimental group will receive an adductor canal catheter and block under ultrasound guidance with the final position of catheter between the femoral artery and nerve. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic.
Time Until Timed Up and Go Test Achieved	33.4 Hours Standard Deviation 7.0	46.8 Hours Standard Deviation 14.5

SECONDARY outcome

Timeframe: 7 postoperative days

The time in hours until a patient could ambulate at least 30 meters independently (regardless of time to achieve the 30 meters)

Outcome measures

Outcome measures
Measure	Control n=41 Participants Femoral perineural local anesthetic infusion Active comparator: Control: Femoral perineural local anesthetic infusion: The control group will receive a femoral nerve catheter and block under ultrasound guidance with the final position of catheter posterior to the femoral nerve and lateral to the femoral artery. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic.	Experimental n=39 Participants Adductor canal perineural local anesthetic infusion Experimental: Adductor Canal perineural local anesthetic infusion: The experimental group will receive an adductor canal catheter and block under ultrasound guidance with the final position of catheter between the femoral artery and nerve. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic.
Time Until Ambulation at Least 30 Meters	40.9 Hours Standard Deviation 13.0	56.6 Hours Standard Deviation 16.7

SECONDARY outcome

Timeframe: Postoperative Days 1-3

The amount of pain evaluated using the 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain

Outcome measures

Outcome measures
Measure	Control n=41 Participants Femoral perineural local anesthetic infusion Active comparator: Control: Femoral perineural local anesthetic infusion: The control group will receive a femoral nerve catheter and block under ultrasound guidance with the final position of catheter posterior to the femoral nerve and lateral to the femoral artery. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic.	Experimental n=39 Participants Adductor canal perineural local anesthetic infusion Experimental: Adductor Canal perineural local anesthetic infusion: The experimental group will receive an adductor canal catheter and block under ultrasound guidance with the final position of catheter between the femoral artery and nerve. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic.
Pain Level Postoperative Day 1 (08:00-16:00)	4.4 score on a scale Standard Deviation 2.0	3.7 score on a scale Standard Deviation 2.3
Pain Level Postoperative Day 2 (08:00-16:00)	3.7 score on a scale Standard Deviation 1.9	3.4 score on a scale Standard Deviation 2.1
Pain Level Postoperative Day 3 (00:00-8:00)	2.5 score on a scale Standard Deviation 2.1	2.8 score on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: Postoperative Days 0-3

Amount of opioid consumed as measured with intravenous morphine equivalents in milligrams

Outcome measures

Outcome measures
Measure	Control n=41 Participants Femoral perineural local anesthetic infusion Active comparator: Control: Femoral perineural local anesthetic infusion: The control group will receive a femoral nerve catheter and block under ultrasound guidance with the final position of catheter posterior to the femoral nerve and lateral to the femoral artery. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic.	Experimental n=39 Participants Adductor canal perineural local anesthetic infusion Experimental: Adductor Canal perineural local anesthetic infusion: The experimental group will receive an adductor canal catheter and block under ultrasound guidance with the final position of catheter between the femoral artery and nerve. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic.
Opioid Consumption Recovery Room	8.6 milligrams Standard Deviation 7.6	8.0 milligrams Standard Deviation 8.5
Opioid Consumption Postoperative Day 0 (day)	0.9 milligrams Standard Deviation 2.3	1.5 milligrams Standard Deviation 4.6
Opioid Consumption Postoperative Day 0 (evening)	7.2 milligrams Standard Deviation 6.5	8.5 milligrams Standard Deviation 6.2
Opioid Consumption Postoperative Day 1 (night)	5.1 milligrams Standard Deviation 6.7	5.6 milligrams Standard Deviation 6.5
Opioid Consumption Postoperative Day 1 (Day)	11.0 milligrams Standard Deviation 6.9	12.6 milligrams Standard Deviation 10.0
Opioid Consumption Postoperative Day 1 (evening)	8.6 milligrams Standard Deviation 5.5	10.9 milligrams Standard Deviation 6.3
Opioid Consumption Postoperative Day 2 (night)	4.1 milligrams Standard Deviation 4.6	5.6 milligrams Standard Deviation 6.2
Opioid Consumption Postoperative Day 2 (day)	9.6 milligrams Standard Deviation 6.5	10.2 milligrams Standard Deviation 6.8
Opioid Consumption Postoperative Day 2 (evening)	6.5 milligrams Standard Deviation 5.8	7.2 milligrams Standard Deviation 6.5
Opioid Consumption Postoperative Day 3 (night	4.9 milligrams Standard Deviation 6.4	5.1 milligrams Standard Deviation 5.8

Adverse Events

Control

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Control n=41 participants at risk Femoral perineural local anesthetic infusion Active comparator: Control: Femoral perineural local anesthetic infusion: The control group will receive a femoral nerve catheter and block under ultrasound guidance with the final position of catheter posterior to the femoral nerve and lateral to the femoral artery. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic.	Experimental n=39 participants at risk Adductor canal perineural local anesthetic infusion Experimental: Adductor Canal perineural local anesthetic infusion: The experimental group will receive an adductor canal catheter and block under ultrasound guidance with the final position of catheter between the femoral artery and nerve. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic.
Musculoskeletal and connective tissue disorders Fall	7.3% 3/41 • Number of events 3 • First postoperative week	5.1% 2/39 • Number of events 2 • First postoperative week

Other adverse events

Adverse event data not reported

Additional Information

Brian Ilfeld

University of California San Diego

Phone: 858-822-2171

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place