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Total Knee ArthroplastyNCT01333943

Saphenous Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty

A study testing Study Group: Experimental in people with Total Knee Arthroplasty, 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

Currently, the regional anesthetic standard of care for total knee replacement surgery is combined spinal/epidural, with or without a femoral nerve block, or FNB. Lasting approximately 18 hours, the FNB works by numbing the femoral nerve (and its branches), which is the major nerve controlling the knee joint. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Total Knee Arthroplasty
What is being tested?
Study Group: Experimental
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteUnited States
Study dates
Mar 2011to Nov 2011
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 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients ages 18-90 undergoing primary unilateral total knee arthroplasty
  • Planned use of neuraxial anesthesia
  • Ability to follow study protocol
  • American Society of Anesthesiology (ASA) Class 1-3

Who cannot join

  • Contraindication to a spinal or epidural anesthetic
  • 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 a pre-existing neuropathy on the operative limb
  • Contraindication to a femoral nerve block or saphenous nerve block
  • Allergy to any of the study medications
  • 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 (Adductor Canal) Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty: A Novel Approach for Postoperative Analgesia

Currently, the regional anesthetic standard of care for total knee replacement surgery is combined spinal/epidural, with or without a femoral nerve block, or FNB. Lasting approximately 18 hours, the FNB works by numbing the femoral nerve (and its branches), which is the major nerve controlling the knee joint. The femoral nerve also provides movement and sensation. While this regional anesthetic technique offers significant postoperative pain relief, it is possible that it may cause muscle weakness and increase patients' recovery time. Hence there is a need for an alternative technique, one that may help minimize postoperative pain as effectively as the FNB, while not causing weakness of the quadriceps muscle.

The saphenous nerve, a branch of the femoral nerve, provides sensation to the knee. Thus it is hypothesized that 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 with the FNB, the quadriceps muscle itself will still be able to function.

Patients will be randomized to receive FNB or saphenous nerve block. Quadriceps strength will be tested using a dynamometer before surgery (baseline), 6-8 hours following anesthesia administration, and on postoperative days 1 and 2. It is hypothesized that patients who receive FNB will experience a 50% decrease in quadriceps strength compared to baseline.

Being tested
Study Group: Experimental, Control Group
Keywords
Total Knee Replacement, Regional Anesthesia, Quadriceps, Muscle Strength, Muscle Strength Dynamometer, Quadriceps muscle strength after regional anesthesia for TKA

What participants receive

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

  • Study Group: ExperimentalProcedure or surgery

    Also called Saphenous (Adductor Canal) Nerve Block

    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 GroupProcedure or surgery

    Also called Femoral Nerve Block

    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).

Study groups in NCT01333943
Study groupRoleWhat they receive
ExperimentalExperimentalSaphenous (Adductor Canal) Nerve Block
Receives: Procedure: Study Group: Experimental
ControlActive comparatorFemoral Nerve Block
Receives: Procedure: Control Group

What is being measured

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

  1. Quadriceps Muscle Strength

    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.

    Measured: 48 hours following administration of anesthesia.

Secondary outcomes (5)

  1. Total Opioid Usage

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

    Measured: Postoperative day 4.

  2. NRS Pain Scores at Rest

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

    Measured: Postoperative day 4.

  3. Patient Satisfaction With the Nerve Block.

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

    Measured: 24 hours following administration of anesthesia.

  4. Incidence of Postoperative Complications.

    Measured: Postoperative day 4.

  5. Total Length of Hospital Stay

    Measured: Total length of hospital stay

Timeline

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

  1. First posted12 Apr 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionNov 2011
  4. Study completionNov 2011

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01333943
Sponsor's protocol ID
2012-031
Status last verified
Apr 2022
First submitted
8 Apr 2011
Last updated
11 May 2022
Data monitoring committee
Yes

Publications

  • Maffiuletti NA. Assessment of hip and knee muscle function in orthopaedic practice and research. J Bone Joint Surg Am. 2010 Jan;92(1):220-9. doi: 10.2106/JBJS.I.00305.

    PubMed 20048117

  • Bohannon RW. Measuring knee extensor muscle strength. Am J Phys Med Rehabil. 2001 Jan;80(1):13-8. doi: 10.1097/00002060-200101000-00004.

    PubMed 11138949

  • 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, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.

    PubMed 9661552

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Study Group: Experimental in people with Total Knee Arthroplasty, 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 4 inclusion and 8 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 11 May 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 18 Dec 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?

Quadriceps Muscle Strength (time frame: 48 hours following administration of anesthesia.). 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 NCT01333943, which also lists 7 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 11 May 2022.

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