- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01333943
Saphenous Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty
Saphenous (Adductor Canal) Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty: A Novel Approach for Postoperative Analgesia
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Hospital for Special Surgery
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
Saphenous (Adductor Canal) Nerve Block
|
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 Names:
|
|
Active Comparator: Control
Femoral Nerve Block
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quadriceps Muscle Strength
Time Frame: 48 hours following administration of anesthesia.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Opioid Usage
Time Frame: Postoperative day 4.
|
Opioid consumption data were collected and converted to oral morphine equivalents.
|
Postoperative day 4.
|
|
NRS Pain Scores at Rest
Time Frame: Postoperative day 4.
|
Patients rated pain on a scale of 0-10, with 0 representing no pain and 10 representing worst pain.
|
Postoperative day 4.
|
|
Patient Satisfaction With the Nerve Block.
Time Frame: 24 hours following administration of anesthesia.
|
Patient satisfaction was measured on a 0-10 scale (0=not satisfied; 10=very satisfied).
|
24 hours following administration of anesthesia.
|
|
Incidence of Postoperative Complications.
Time Frame: Postoperative day 4.
|
Postoperative day 4.
|
|
|
Total Length of Hospital Stay
Time Frame: Total length of hospital stay
|
Total length of hospital stay
|
Collaborators and Investigators
Investigators
- Principal Investigator: David H. Kim, MD, Hospital for Special Surgery, New York
Publications and helpful links
General Publications
- 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.
- 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.
- Bohannon RW. Measuring knee extensor muscle strength. Am J Phys Med Rehabil. 2001 Jan;80(1):13-8. doi: 10.1097/00002060-200101000-00004.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2012-031
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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