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Saphenous Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT01333943
Recruitment Status : Completed
First Posted : April 12, 2011
Results First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

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.


Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Procedure: Study Group: Experimental Procedure: Control Group Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Saphenous (Adductor Canal) Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty: A Novel Approach for Postoperative Analgesia
Study Start Date : March 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Experimental
Saphenous (Adductor Canal) Nerve Block
Procedure: Study Group: Experimental
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).
Other Name: Saphenous (Adductor Canal) Nerve Block
Active Comparator: Control
Femoral Nerve Block
Procedure: Control Group
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).
Other Name: Femoral Nerve Block



Primary Outcome Measures :
  1. Quadriceps Muscle Strength [ Time Frame: 48 hours following administration of anesthesia. ]
    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.


Secondary Outcome Measures :
  1. Total Opioid Usage [ Time Frame: Postoperative day 4. ]
    Opioid consumption data were collected and converted to oral morphine equivalents.

  2. NRS Pain Scores at Rest [ Time Frame: Postoperative day 4. ]
    Patients rated pain on a scale of 0-10, with 0 representing no pain and 10 representing worst pain.

  3. Patient Satisfaction With the Nerve Block. [ Time Frame: 24 hours following administration of anesthesia. ]
    Patient satisfaction was measured on a 0-10 scale (0=not satisfied; 10=very satisfied).

  4. Incidence of Postoperative Complications. [ Time Frame: Postoperative day 4. ]
  5. Total Length of Hospital Stay [ Time Frame: Total length of hospital stay ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01333943


Locations
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Principal Investigator: David H. Kim, MD Hospital for Special Surgery, New York

Additional Information:
Publications:
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01333943     History of Changes
Other Study ID Numbers: 10146
First Posted: April 12, 2011    Key Record Dates
Results First Posted: December 18, 2017
Last Update Posted: December 18, 2017
Last Verified: May 2017

Keywords provided by Hospital for Special Surgery, New York:
Total Knee Replacement
Regional Anesthesia
Quadriceps
Muscle Strength
Muscle Strength Dynamometer
Quadriceps muscle strength after regional anesthesia for TKA