Clinical trial NCT01333943: Saphenous Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty
Official title: Saphenous (Adductor Canal) Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty: A Novel Approach for Postoperative Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: Total Knee Replacement
Regional Anesthesia
Quadriceps
Muscle Strength
Muscle Strength Dynamometer
Quadriceps muscle strength after regional anesthesia for TKA
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2011-04-12
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Quadriceps Muscle Strength
timeFrame: 48 hours following administration of anesthesia.
Secondary outcomes:
measure: Total Opioid Usage
timeFrame: Postoperative day 4.
measure: NRS Pain Scores at Rest
timeFrame: Postoperative day 4.
measure: Patient Satisfaction With the Nerve Block.
timeFrame: 24 hours following administration of anesthesia.
measure: Incidence of Postoperative Complications.
timeFrame: Postoperative day 4.
measure: Total Length of Hospital Stay
timeFrame: Total length of hospital stay
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: David H. Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.
citation: Kandasami M, Kinninmonth AW, Sarungi M, Baines J, Scott NB. Femoral nerve block for total knee replacement - a word of caution. Knee. 2009 Mar;16(2):98-100. doi: 10.1016/j.knee.2008.10.007. Epub 2008 Nov 28.
citation: Horn JL, Pitsch T, Salinas F, Benninger B. Anatomic basis to the ultrasound-guided approach for saphenous nerve blockade. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):486-9. doi: 10.1097/AAP.0b013e3181ae11af.
citation: Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gumus H, Ates Y. Saphenous nerve block is an effective regional technique for post-menisectomy pain. Knee Surg Sports Traumatol Arthrosc. 2008 Sep;16(9):855-8. doi: 10.1007/s00167-008-0572-4. Epub 2008 Jun 24.