Clinical trial NCT01505374: Saphenous Nerve Block vs. Femoral Nerve Block for Total Knee Arthroplasty
Official title: Saphenous Nerve Block vs. Femoral Nerve Block for Total Knee Arthroplasty: A Comparative Effectiveness Study in Bilateral Total Knee Arthroplasty Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difference Between Femoral Nerve Block and Saphenous Block
Keywords: Bilateral total knee replacement
Femoral Nerve Block
Saphenous Nerve Block
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2012-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Visual Analogue Scale Pain Score
timeFrame: Up to postoperative day 1
Secondary outcomes:
measure: Tracking Total Opioid Usage
timeFrame: Up to postoperative day 2
measure: Preoperative and Postoperative Thigh Muscle Strength in Both Legs
timeFrame: Up to postoperative day 2
measure: Patient Satisfaction With Nerve Blocks
timeFrame: Up to postoperative day 1
measure: Duration of Motor and Sensory Blockade
timeFrame: Up to postoperative day 2
measure: Rating the Success of the Nerve Blocks
timeFrame: Up to postoperative day 2
measure: Postoperative Complications
timeFrame: Up to postoperative day 2
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: Stavros G. Memtsoudis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.
citation: Singelyn FJ, Ferrant T, Malisse MF, Joris D. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous femoral nerve sheath block on rehabilitation after unilateral total-hip arthroplasty. Reg Anesth Pain Med. 2005 Sep-Oct;30(5):452-7. doi: 10.1016/j.rapm.2005.05.008.
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.
citation: Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.