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OpenTrials
Completed

NCT Number: NCT01505374

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Tracking Total Opioid Usage

    Time frame: Up to postoperative day 2

  2. Preoperative and Postoperative Thigh Muscle Strength in Both Legs

    Time frame: Up to postoperative day 2

    This was measured with a dynamometer to gauge strength.

  3. Patient Satisfaction With Nerve Blocks

    Time frame: Up to postoperative day 1

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

  4. Duration of Motor and Sensory Blockade

    Time frame: Up to postoperative day 2

  5. Rating the Success of the Nerve Blocks

    Time frame: Up to postoperative day 2

  6. Postoperative Complications

    Time frame: Up to postoperative day 2

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 6, 2012
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.