Difference Between Femoral Nerve Block and Saphenous BlockNCT01505374

Saphenous Nerve Block vs. Femoral Nerve Block for Total Knee Arthroplasty

A study testing Study Technique in people with Difference Between Femoral Nerve Block and Saphenous Block, run by Hospital for Special Surgery, New York at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Difference Between Femoral Nerve Block and Saphenous Block
What is being tested?: Study Technique
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Mar 2012to Sep 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All patients ages 40-80 undergoing Bilateral Total Knee Replacement
Planned use of neuraxial anesthesia
Ability to follow study protocol

Who cannot join

Contraindication to a spinal or epidural anesthestic
Not a candidate for bilateral total knee replacement
Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)
Hypersensitivity and/or allergy to local anesthetics
Intraoperative use of any volatile anesthetic
Patients with pre-existing neuropathy on the operative limb

Show all 10Show fewer

Contraindication to femoral nerve block or saphenous nerve block
Allergy to any of the study medications
American Society of Anesthesiologists (ASA) Class 4-5
Non-English speaking patients

Trial locations and contacts

1 site in 1 country.

United States1 site

Hospital for Special Surgery
New York, New York, 10021

Other trials in United States

About this study

Official title: Saphenous Nerve Block vs. Femoral Nerve Block for Total Knee Arthroplasty: A Comparative Effectiveness Study in Bilateral Total Knee Arthroplasty Patients

Currently, the regional anesthetic standard of care for total knee replacement surgery is combined spinal/epidural to provide long-lasting pain relief with or without a femoral nerve block (FNB). The femoral nerve block refers to a technique that your anesthesiologist can use to numb the thigh muscle for approximately 18 hours after surgery. While this technique offers significant pain relief, it is possible it may cause muscle weakness and increase patients' recovery times. Hence there is a need for an alterative anesthetic technique, one that may help minimize postoperative pain as effectively as a femoral nerve block, while not causing weakness of the thigh muscle.

The saphenous nerve, a branch of the femoral nerve, provides sensation to the knee. Thus it is hypothesized by "blocking" or anesthetizing the saphenous nerve with local anesthetic closer to where it branches off, the area around and below the knee will feel numb. Yet unlike the femoral nerve block, the thigh muscle itself will still be able to function.

For patients undergoing two total knee replacements at one time or bilateral total knee replacement, they will be randomly assigned to receive a femoral nerve block on one leg and a saphenous block on the other. Pain levels will be measured and thigh muscle strength will be tested using a dynamometer before surgery, 6-8 hours following anesthesia administration, and on postoperative days 1 and 2.

Conditions: Difference Between Femoral Nerve Block and Saphenous Block
Being tested: Study Technique, Control Technique
Keywords: Bilateral total knee replacement, Femoral Nerve Block, Saphenous Nerve Block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study TechniqueProcedure or surgery
One leg will receive the saphenous nerve block, at the level of the adductor canal (study technique). 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 TechniqueProcedure or surgery
The other leg will receive the femoral nerve block (control technique). 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.

Study groups in NCT01505374
Study group	Role	What they receive
Study Technique Left Leg, Control Technique Right Leg	Experimental	Not described Receives: Procedure: Study Technique; Procedure: Control Technique
Study Technique Right Leg, Control Technique Left Leg	Experimental	Not described Receives: Procedure: Study Technique; Procedure: Control Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Analogue Scale Pain Score
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.
Measured: Up to postoperative day 1

Secondary outcomes (6)

Tracking Total Opioid Usage
Measured: Up to postoperative day 2
Preoperative and Postoperative Thigh Muscle Strength in Both Legs
This was measured with a dynamometer to gauge strength.
Measured: Up to postoperative day 2
Patient Satisfaction With Nerve Blocks
Rated on a 0-10 scale, with a higher score representing greater satisfaction.
Measured: Up to postoperative day 1
Duration of Motor and Sensory Blockade
Measured: Up to postoperative day 2
Rating the Success of the Nerve Blocks
Measured: Up to postoperative day 2
Postoperative Complications
Measured: Up to postoperative day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Sep 2013

First posted6 Jan 2012 (estimated)
Study startMar 2012
Primary completionSep 2013
Study completionSep 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Difference Between Femoral Nerve Block and Saphenous BlockStudies of the same condition, open and under way.
More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01505374
Sponsor's protocol ID: 2012-033
Status last verified: Apr 2022
First submitted: 4 Jan 2012
Last updated: 14 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.
PubMed 10422923
Singelyn FJ, Ferrant T, Malisse MF, Joris D. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous femoral nerve sheath block on rehabilitation after unilateral total-hip arthroplasty. Reg Anesth Pain Med. 2005 Sep-Oct;30(5):452-7. doi: 10.1016/j.rapm.2005.05.008.
PubMed 16135349
Kandasami M, Kinninmonth AW, Sarungi M, Baines J, Scott NB. Femoral nerve block for total knee replacement - a word of caution. Knee. 2009 Mar;16(2):98-100. doi: 10.1016/j.knee.2008.10.007. Epub 2008 Nov 28.
PubMed 19046884
Horn JL, Pitsch T, Salinas F, Benninger B. Anatomic basis to the ultrasound-guided approach for saphenous nerve blockade. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):486-9. doi: 10.1097/AAP.0b013e3181ae11af.
PubMed 19920424
Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gumus H, Ates Y. Saphenous nerve block is an effective regional technique for post-menisectomy pain. Knee Surg Sports Traumatol Arthrosc. 2008 Sep;16(9):855-8. doi: 10.1007/s00167-008-0572-4. Epub 2008 Jun 24.
PubMed 18574578
Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.
PubMed 19916251

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Saphenous Nerve Block vs. Femoral Nerve Block for Total Knee Arthroplasty: A Comparative Effectiveness Study in Bilateral Total Knee Arthroplasty Patients
ClinicalTrials.gov ID: NCT01505374
Acronym / sponsor ID: 2012-033
Conditions: Difference Between Femoral Nerve Block and Saphenous Block
Keywords: Bilateral total knee replacement, Femoral Nerve Block, Saphenous Nerve Block
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Hospital for Special Surgery, New YorkUniversity, hospital or other
Study start: Mar 2012
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 6 Jan 2012 (estimated)
Results: Posted 1 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Study Technique Left Leg, Control Technique Right Leg	Experimental	Procedure: Study Technique, Procedure: Control Technique
Study Technique Right Leg, Control Technique Left Leg	Experimental	Procedure: Study Technique, Procedure: Control Technique

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

All patients ages 40-80 undergoing Bilateral Total Knee Replacement
Planned use of neuraxial anesthesia
Ability to follow study protocol

Key exclusion criteria (10 listed)

Contraindication to a spinal or epidural anesthestic
Not a candidate for bilateral total knee replacement
Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)
Hypersensitivity and/or allergy to local anesthetics
Intraoperative use of any volatile anesthetic

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Study TechniqueOne leg will receive the saphenous nerve block, at the level of the adductor canal (study technique). 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.	Procedure or surgery	Study Technique Left Leg, Control Technique Right Leg, Study Technique Right Leg, Control Technique Left Leg
Control TechniqueThe other leg will receive the femoral nerve block (control technique). 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.	Procedure or surgery	Study Technique Left Leg, Control Technique Right Leg, Study Technique Right Leg, Control Technique Left Leg

Primary outcome

Visual Analogue Scale Pain Score
Time frame: Up to postoperative day 1
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.

6 secondary outcomes

Tracking Total Opioid Usage
Time frame: Up to postoperative day 2
Preoperative and Postoperative Thigh Muscle Strength in Both Legs
Time frame: Up to postoperative day 2
Patient Satisfaction With Nerve Blocks
Time frame: Up to postoperative day 1
Duration of Motor and Sensory Blockade
Time frame: Up to postoperative day 2
Rating the Success of the Nerve Blocks
Time frame: Up to postoperative day 2
Postoperative Complications
Time frame: Up to postoperative day 2

Results and safety

Results posted to the registry on 1 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Technique Right Leg, Control Technique Left Leg	30	29
Study Technique Left Leg, Control Technique Right Leg	30	30

Primary outcome: Visual Analogue Scale Pain Score

Time frame: Up to postoperative day 1. Mean (Standard Deviation). Unit: units on a scale

Measure	Study Technique: Saphenous Nerve Block n = 59	Control Technique: Femoral Nerve Block n = 59
Value	2.81 (2.42)	2.47 (2.38)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: The study was monitored for adverse events over the course of 1 year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Technique: Saphenous Nerve Block	0 of 60 (0%)	1 of 60 (1.7%)	Not reported
Control Technique: Femoral Nerve Block	0 of 60 (0%)	0 of 60 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 10422923Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.
Background: PubMed 16135349Singelyn FJ, Ferrant T, Malisse MF, Joris D. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous femoral nerve sheath block on rehabilitation after unilateral total-hip arthroplasty. Reg Anesth Pain Med. 2005 Sep-Oct;30(5):452-7. doi: 10.1016/j.rapm.2005.05.008.
Background: PubMed 19046884Kandasami M, Kinninmonth AW, Sarungi M, Baines J, Scott NB. Femoral nerve block for total knee replacement - a word of caution. Knee. 2009 Mar;16(2):98-100. doi: 10.1016/j.knee.2008.10.007. Epub 2008 Nov 28.
Background: PubMed 19920424Horn JL, Pitsch T, Salinas F, Benninger B. Anatomic basis to the ultrasound-guided approach for saphenous nerve blockade. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):486-9. doi: 10.1097/AAP.0b013e3181ae11af.
Background: PubMed 18574578Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gumus H, Ates Y. Saphenous nerve block is an effective regional technique for post-menisectomy pain. Knee Surg Sports Traumatol Arthrosc. 2008 Sep;16(9):855-8. doi: 10.1007/s00167-008-0572-4. Epub 2008 Jun 24.
Background: PubMed 19916251Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stavros G. Memtsoudis, MD, PhD principal investigator

Hospital for Special Surgery, New York

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Study Technique in people with Difference Between Femoral Nerve Block and Saphenous Block, run by Hospital for Special Surgery, New York at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale Pain Score (time frame: Up to postoperative day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01505374, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.