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

Not Applicable
Completed
Conditions
Difference Between Femoral Nerve Block and Saphenous Block
Interventions
Procedure: Study Technique
Procedure: Control Technique
Registration Number
NCT01505374
Lead Sponsor
Hospital for Special Surgery, New York
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
Inclusion Criteria
  • All patients ages 40-80 undergoing Bilateral Total Knee Replacement
  • Planned use of neuraxial anesthesia
  • Ability to follow study protocol
Exclusion Criteria
  • 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Study Technique Right Leg, Control Technique Left LegStudy Technique-
Study Technique Right Leg, Control Technique Left LegControl Technique-
Study Technique Left Leg, Control Technique Right LegControl Technique-
Study Technique Left Leg, Control Technique Right LegStudy Technique-
Primary Outcome Measures
NameTimeMethod
Visual Analogue Scale Pain ScoreUp 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.

Secondary Outcome Measures
NameTimeMethod
Preoperative and Postoperative Thigh Muscle Strength in Both LegsUp to postoperative day 2

This was measured with a dynamometer to gauge strength.

Postoperative ComplicationsUp to postoperative day 2
Duration of Motor and Sensory BlockadeUp to postoperative day 2
Tracking Total Opioid UsageUp to postoperative day 2
Rating the Success of the Nerve BlocksUp to postoperative day 2
Patient Satisfaction With Nerve BlocksUp to postoperative day 1

Rated on a 0-10 scale, with a higher score representing greater satisfaction.

Trial Locations

Locations (1)

Hospital for Special Surgery

🇺🇸

New York, New York, United States

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