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

NCT01505374 | Completed Results DMC

• 1 other identifier: 2012-033
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Bilateral total knee replacement; Femoral Nerve Block; Saphenous Nerve Block

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to postoperative day 1

Secondary Outcomes (6)

• Tracking Total Opioid Usage

  Up to postoperative day 2

• Preoperative and Postoperative Thigh Muscle Strength in Both Legs

  Up to postoperative day 2

• Patient Satisfaction With Nerve Blocks

  Up to postoperative day 1

• Duration of Motor and Sensory Blockade

  Up to postoperative day 2

• Rating the Success of the Nerve Blocks

  Up to postoperative day 2

Study Arms (2)

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

Interventions

Study Technique PROCEDURE

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.

Study Technique Left Leg, Control Technique Right Leg; Study Technique Right Leg, Control Technique Left Leg

Control Technique PROCEDURE

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 Technique Left Leg, Control Technique Right Leg; Study Technique Right Leg, Control Technique Left Leg

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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

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 (6)

• 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, 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.

  PMID: 16135349 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

• 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.

  PMID: 19916251 BACKGROUND

Results Point of Contact

• Title: Stavros G. Memtsoudis, MD, PhD
• Organization: Hospital for Special Surgery

memtsoudiss@hss.edu

212-606-1206

Study Officials

• Stavros G. Memtsoudis, MD, PhD

  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: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2012
• First Posted: January 6, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 14, 2022
• Results First Posted: May 1, 2017

Record last verified: 2022-04

Locations

US (1)