Saphenous Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

Saphenous (Adductor Canal) Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty: A Novel Approach for Postoperative Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01333943
• Other study ID #: 2012-031
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: November 2011

Study information

• Verified date: April 2022
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

References & Publications (7)

Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gümüs 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. — View Citation

Bohannon RW. Measuring knee extensor muscle strength. Am J Phys Med Rehabil. 2001 Jan;80(1):13-8. — View 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. — View 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. — View 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. — View Citation

Maffiuletti NA. Assessment of hip and knee muscle function in orthopaedic practice and research. J Bone Joint Surg Am. 2010 Jan;92(1):220-9. doi: 10.2106/JBJS.I.00305. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quadriceps Muscle Strength	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.	48 hours following administration of anesthesia.
Secondary	Total Opioid Usage	Opioid consumption data were collected and converted to oral morphine equivalents.	Postoperative day 4.
Secondary	NRS Pain Scores at Rest	Patients rated pain on a scale of 0-10, with 0 representing no pain and 10 representing worst pain.	Postoperative day 4.
Secondary	Patient Satisfaction With the Nerve Block.	Patient satisfaction was measured on a 0-10 scale (0=not satisfied; 10=very satisfied).	24 hours following administration of anesthesia.
Secondary	Incidence of Postoperative Complications.		Postoperative day 4.
Secondary	Total Length of Hospital Stay		Total length of hospital stay

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