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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01505374
First received: January 4, 2012
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Difference Between Femoral Nerve Block and Saphenous Block
Procedure: Study Technique
Procedure: Control Technique

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Saphenous Nerve Block vs. Femoral Nerve Block for Total Knee Arthroplasty: A Comparative Effectiveness Study in Bilateral Total Knee Arthroplasty Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The primary outcome is the postoperative pain in each leg within the first 24 hours postoperatively [ Time Frame: Up to postoperative day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tracking total opioid usage [ Time Frame: Up to postoperative day 2 ] [ Designated as safety issue: No ]
  • Difference between preoperative and postoperative thigh muscle strength in both legs [ Time Frame: Up to postoperative day 2 ] [ Designated as safety issue: No ]
  • Patient satisfaction with nerve blocks [ Time Frame: Up to postoperative day 1 ] [ Designated as safety issue: No ]
  • Duration of motor and sensory blockade [ Time Frame: Up to postoperative day 2 ] [ Designated as safety issue: No ]
  • Rating the success of the nerve blocks [ Time Frame: Up to postoperative day 2 ] [ Designated as safety issue: No ]
  • Postoperative complications [ Time Frame: Up to postoperative day 2 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: March 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Technique: Saphenous Nerve Block Procedure: Study Technique
One leg 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% 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.
Active Comparator: Control technique: Femoral Nerve Block Procedure: Control Technique
The other leg will receive the femoral nerve block. 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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505374

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: Stavros G. Memtsoudis, MD, PhD Hospital for Special Surgery, New York
  More Information

Publications:
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01505374     History of Changes
Other Study ID Numbers: 11155
Study First Received: January 4, 2012
Last Updated: December 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Hospital for Special Surgery, New York:
Bilateral total knee replacement
Femoral Nerve Block
Saphenous Nerve Block

ClinicalTrials.gov processed this record on April 17, 2014