Saphenous Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty

NCT01333943 | Completed Results DMC

• 1 other identifier: 2012-031
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Total Knee Arthroplasty

Keywords

Total Knee Replacement; Regional Anesthesia; Quadriceps; Muscle Strength; Muscle Strength Dynamometer; Quadriceps muscle strength after regional anesthesia for TKA

Outcome Measures

Primary Outcomes (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.

  48 hours following administration of anesthesia.

Secondary Outcomes (5)

• Total Opioid Usage

  Postoperative day 4.

• NRS Pain Scores at Rest

  Postoperative day 4.

• Patient Satisfaction With the Nerve Block.

  24 hours following administration of anesthesia.

• Incidence of Postoperative Complications.

  Postoperative day 4.

• Total Length of Hospital Stay

  Total length of hospital stay

Study Arms (2)

Experimental

EXPERIMENTAL

Saphenous (Adductor Canal) Nerve Block

Procedure: Study Group: Experimental

Control

ACTIVE COMPARATOR

Femoral Nerve Block

Procedure: Control Group

Interventions

Study Group: Experimental PROCEDURE

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).

Also known as: Saphenous (Adductor Canal) Nerve Block

Experimental

Control Group PROCEDURE

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).

Also known as: Femoral Nerve Block

Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (7)

• 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.

  PMID: 20048117 BACKGROUND

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

  PMID: 11138949 BACKGROUND

• 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.

  PMID: 10422923 BACKGROUND

• 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.

  PMID: 9661552 BACKGROUND

• 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.

  PMID: 19046884 BACKGROUND

• 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.

  PMID: 19920424 BACKGROUND

• 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.

  PMID: 18574578 BACKGROUND

Related Links

• This is the link to the Hospital for Special Surgery home website.

MeSH Terms

Interventions

Nerve Block; Control Groups

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Limitations and Caveats

The duration of analgesia from the ACB block is unclear and was not measured. Also, a large follow-up study is needed to investigate whether ACB improves rehabilitation, incidence of falls, and/or length of hospital stay.

Results Point of Contact

• Title: David H. Kim, MD
• Organization: Hospital for Special Surgery

KimD@HSS.EDU

(212) 606-1206

Study Officials

• David H. Kim, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2011
• First Posted: April 12, 2011
• Study Start: March 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: May 11, 2022
• Results First Posted: December 18, 2017

Record last verified: 2022-04

Locations

US (1)