Trial Outcomes & Findings for Saphenous Nerve Block vs. Femoral Nerve Block for Total Knee Arthroplasty (NCT NCT01505374)
NCT ID: NCT01505374
Last Updated: 2022-04-14
Results Overview
The primary outcome is the postoperative pain in each leg within the first 24 hours postoperatively. VAS pain scores could range from 0 to 10. Higher values represent a worse outcome.
COMPLETED
NA
60 participants
Up to postoperative day 1
2022-04-14
Participant Flow
Recruitment was from the period of 4/16/12-9/4/13 at the Hospital for Special Surgery. Patients were identified on the day of surgery and randomized prior to the start of surgery.
Patients were excluded prior to randomization if they had contraindications to spinal or epidural anesthesia, had chronic opioid use, pre-existing neuropathies in the limbs, allergies to pre-operative medications, contraindication to assigned nerve blocks, allergy to local anesthetic, American Society of Anesthesia 4-5, and non-English speaking.
Participant milestones
| Measure |
Study Technique Right Leg, Control Technique Left Leg
|
Study Technique Left Leg, Control Technique Right Leg
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Study Technique Right Leg, Control Technique Left Leg
|
Study Technique Left Leg, Control Technique Right Leg
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Saphenous Nerve Block vs. Femoral Nerve Block for Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
All Study Participants
n=60 Participants
|
|---|---|
|
Age, Customized
Age
|
64.41 years
STANDARD_DEVIATION 7.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to postoperative day 1The primary outcome is the postoperative pain in each leg within the first 24 hours postoperatively. VAS pain scores could range from 0 to 10. Higher values represent a worse outcome.
Outcome measures
| Measure |
Study Technique: Saphenous Nerve Block
n=59 Participants
Study Technique: One leg 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% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
|
Control Technique: Femoral Nerve Block
n=59 Participants
Control Technique: The other leg will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
|
|---|---|---|
|
Visual Analogue Scale Pain Score
|
2.81 units on a scale
Standard Deviation 2.42
|
2.47 units on a scale
Standard Deviation 2.38
|
SECONDARY outcome
Timeframe: Up to postoperative day 2Outcome measures
| Measure |
Study Technique: Saphenous Nerve Block
n=59 Participants
Study Technique: One leg 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% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
|
Control Technique: Femoral Nerve Block
Control Technique: The other leg will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
|
|---|---|---|
|
Tracking Total Opioid Usage
|
133.11 milligrams
Standard Deviation 114.53
|
—
|
SECONDARY outcome
Timeframe: Up to postoperative day 2This was measured with a dynamometer to gauge strength.
Outcome measures
| Measure |
Study Technique: Saphenous Nerve Block
n=59 Participants
Study Technique: One leg 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% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
|
Control Technique: Femoral Nerve Block
n=59 Participants
Control Technique: The other leg will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
|
|---|---|---|
|
Preoperative and Postoperative Thigh Muscle Strength in Both Legs
Baseline
|
17.06 kilogram-force unit
Standard Deviation 10.65
|
17.24 kilogram-force unit
Standard Deviation 14.37
|
|
Preoperative and Postoperative Thigh Muscle Strength in Both Legs
6-8 h postoperative
|
2.86 kilogram-force unit
Standard Deviation 3.55
|
2.45 kilogram-force unit
Standard Deviation 3.31
|
|
Preoperative and Postoperative Thigh Muscle Strength in Both Legs
24 h postoperative
|
5.00 kilogram-force unit
Standard Deviation 3.68
|
5.08 kilogram-force unit
Standard Deviation 4.06
|
|
Preoperative and Postoperative Thigh Muscle Strength in Both Legs
48 postoperative
|
3.35 kilogram-force unit
Standard Deviation 2.62
|
3.76 kilogram-force unit
Standard Deviation 3.35
|
SECONDARY outcome
Timeframe: Up to postoperative day 1Rated on a 0-10 scale, with a higher score representing greater satisfaction.
Outcome measures
| Measure |
Study Technique: Saphenous Nerve Block
n=59 Participants
Study Technique: One leg 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% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
|
Control Technique: Femoral Nerve Block
n=59 Participants
Control Technique: The other leg will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
|
|---|---|---|
|
Patient Satisfaction With Nerve Blocks
|
8 units on a scale
Standard Deviation 2.4
|
8.4 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Up to postoperative day 2Population: The duration of motor and sensory blockade was not calculated and analyzed, because accurate data regarding block resolution time could not be acquired from patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to postoperative day 2Population: The success of nerve blocks was not collected or analyzed. Instead, muscle strength was collected (data are presented in another table).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to postoperative day 2Population: Analysis of postoperative complications was not performed because sufficient data could not be collected regarding the secondary outcome
Outcome measures
Outcome data not reported
Adverse Events
Study Technique: Saphenous Nerve Block
Control Technique: Femoral Nerve Block
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Study Technique: Saphenous Nerve Block
n=60 participants at risk
|
Control Technique: Femoral Nerve Block
n=60 participants at risk
|
|---|---|---|
|
General disorders
Epidural failure
|
1.7%
1/60 • Number of events 1 • The study was monitored for adverse events over the course of 1 year.
|
0.00%
0/60 • The study was monitored for adverse events over the course of 1 year.
|
Additional Information
Stavros G. Memtsoudis, MD, PhD
Hospital for Special Surgery
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place