Sponsor study identifier
interventional
60
1 country
1
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2013
Actual (reported)Study Completion
September 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2013
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 4, 2012
Actual (reported)January 6, 2012
Actual (reported)March 2012
Date type not reportedThis date has not been verified as actual or estimated.
September 2013
Actual (reported)September 2013
Actual (reported)May 1, 2017
Actual (reported)Visual Analogue Scale Pain Score
The primary outcome is the postoperative pain in each leg within the first 24 hours postoperatively. VAS pain scores could range from 0 to 10. Higher values represent a worse outcome.
Up to postoperative day 1
Tracking Total Opioid Usage
Up to postoperative day 2
Preoperative and Postoperative Thigh Muscle Strength in Both Legs
Up to postoperative day 2
Patient Satisfaction With Nerve Blocks
Up to postoperative day 1
Duration of Motor and Sensory Blockade
Up to postoperative day 2
Rating the Success of the Nerve Blocks
Up to postoperative day 2
One leg will receive the saphenous nerve block, at the level of the adductor canal (study technique). 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.
Hospital for Special Surgery
New York, New York, 10021, United States
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.
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.
Stavros G. Memtsoudis, MD, PhD
Hospital for Special Surgery, New York
60 participants (actual enrollment reported by the registry).
First Submitted
January 4, 2012
First Posted
January 6, 2012
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
The other leg will receive the femoral nerve block (control technique). 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
Primary Completion
September 2013
Actual (reported)Study Completion
September 2013
Actual (reported)Last Updated
April 14, 2022
Results First Posted
May 1, 2017
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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