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Saphenous Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by:
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01333943
First received: April 8, 2011
Last updated: November 14, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Total Knee Arthroplasty
 Procedure: Study Group: Experimental
Procedure: Control Group
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

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

Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • The primary outcome is the difference between preoperative and postoperative quadriceps muscle strength of both the operative and nonoperative legs, as measured by a handheld dynamometer while patients perform isometric exercises. [ Time Frame: Up to 48 hours following administration of anesthesia. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The first secondary outcome is tracking total opioid usage. [ Time Frame: Up to postoperative day 4. ] [ Designated as safety issue: No ]
  • The second secondary outcome is recording NRS pain scores. [ Time Frame: Up to postoperative day 4. ] [ Designated as safety issue: No ]
  • The third secondary outcome is recording patient satisfaction with the nerve block. [ Time Frame: Up to 24 hours following administration of anesthesia. ] [ Designated as safety issue: No ]
  • The fourth secondary outcome is rating the success of the nerve block. [ Time Frame: Up to 48 hours following administration of anesthesia. ] [ Designated as safety issue: No ]
  • Another secondary outcome is tracking the duration of motor and sensory blockade. [ Time Frame: On average, up to 48 hours after administration of anesthesia. ] [ Designated as safety issue: No ]
  • Another secondary outcome is tracking the incidence of postoperative complications (if any). [ Time Frame: Up to postoperative day 4. ] [ Designated as safety issue: No ]
  • Another secondary outcome is tracking patients' ability to reach physical therapy milestones. [ Time Frame: Up to postoperative day 4. ] [ Designated as safety issue: No ]
  • The final secondary outcome is total length of hospital stay (in hours). [ Time Frame: Up to postoperative day 4. ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: March 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
This is the link to the Hospital for Special Surgery home website.  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: David H. Kim, Hospital for Special Surgery
ClinicalTrials.gov Identifier: NCT01333943     History of Changes
Other Study ID Numbers: 10146
Study First Received: April 8, 2011
Last Updated: November 14, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013