Trial Outcomes & Findings for Saphenous Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty (NCT NCT01333943)

NCT ID: NCT01333943

Last Updated: 2022-05-11

Results Overview

Measurements were made by a handheld dynamometer while patients perform isometric exercises. Results are presented in kilogram-force (kgF) units. One kgF is equal to 9.80665 N.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 94 participants
• Primary outcome timeframe: 48 hours following administration of anesthesia.
• Results posted on: 2022-05-11

Participant Flow

Participant milestones

Measure	Experimental Saphenous (Adductor Canal) Nerve Block Study Group: Experimental: The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).	Control Femoral Nerve Block Control Group: The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).
Overall Study STARTED	47	47
Overall Study COMPLETED	46	47
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Experimental Saphenous (Adductor Canal) Nerve Block Study Group: Experimental: The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).	Control Femoral Nerve Block Control Group: The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).
Overall Study Known neuropathy	1	0

Baseline Characteristics

Saphenous Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty

Baseline characteristics by cohort

Measure	Experimental n=46 Participants Saphenous (Adductor Canal) Nerve Block Study Group: Experimental: The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).	Control n=47 Participants Femoral Nerve Block Control Group: The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).	Total n=93 Participants Total of all reporting groups
Age, Continuous	68.0 years STANDARD_DEVIATION 9.4 • n=5 Participants	67.6 years STANDARD_DEVIATION 11.3 • n=7 Participants	67.8 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	29 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants	47 participants n=7 Participants	93 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours following administration of anesthesia.

Measurements were made by a handheld dynamometer while patients perform isometric exercises. Results are presented in kilogram-force (kgF) units. One kgF is equal to 9.80665 N.

Outcome measures

Measure	Experimental n=46 Participants Saphenous (Adductor Canal) Nerve Block Study Group: Experimental: The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).	Control n=47 Participants Femoral Nerve Block Control Group: The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).
Quadriceps Muscle Strength	7.3 kilogram-force Standard Deviation 5.4	2.2 kilogram-force Standard Deviation 3.8

SECONDARY outcome

Timeframe: Postoperative day 4.

Population: One patient was excluded from analysis due to a condition. Data from the remaining 93 patients were analyzed.

Opioid consumption data were collected and converted to oral morphine equivalents.

Outcome measures

Measure	Experimental n=46 Participants Saphenous (Adductor Canal) Nerve Block Study Group: Experimental: The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).	Control n=47 Participants Femoral Nerve Block Control Group: The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).
Total Opioid Usage	36.6 mg Standard Deviation 17.9	35.8 mg Standard Deviation 20.7

SECONDARY outcome

Timeframe: Postoperative day 4.

Population: One patient was excluded at the time of analysis, and the remaining 93 patients were included in the analysis.

Patients rated pain on a scale of 0-10, with 0 representing no pain and 10 representing worst pain.

Outcome measures

Measure	Experimental n=46 Participants Saphenous (Adductor Canal) Nerve Block Study Group: Experimental: The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).	Control n=47 Participants Femoral Nerve Block Control Group: The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).
NRS Pain Scores at Rest	1.7 units on a scale Standard Deviation 1.9	0.9 units on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: 24 hours following administration of anesthesia.

Population: One patient was excluded from analysis, and the remaining 93 patients were included.

Patient satisfaction was measured on a 0-10 scale (0=not satisfied; 10=very satisfied).

Outcome measures

Measure	Experimental n=46 Participants Saphenous (Adductor Canal) Nerve Block Study Group: Experimental: The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).	Control n=47 Participants Femoral Nerve Block Control Group: The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).
Patient Satisfaction With the Nerve Block.	8.8 units on a scale Standard Deviation 1.9	9.1 units on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: Postoperative day 4.

Outcome measures

Measure	Experimental n=46 Participants Saphenous (Adductor Canal) Nerve Block Study Group: Experimental: The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).	Control n=47 Participants Femoral Nerve Block Control Group: The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).
Incidence of Postoperative Complications.	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Total length of hospital stay

Outcome measures

Measure	Experimental n=46 Participants Saphenous (Adductor Canal) Nerve Block Study Group: Experimental: The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).	Control n=47 Participants Femoral Nerve Block Control Group: The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).
Total Length of Hospital Stay	3.7 days Standard Deviation 0.8	3.6 days Standard Deviation 0.8

Adverse Events

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

David H. Kim, MD

Hospital for Special Surgery

Phone: (212) 606-1206

Email: KimD@HSS.EDU

Results disclosure agreements

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