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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Saphenous (Adductor Canal) Nerve Block |
|
| Control | Active Comparator | Femoral Nerve Block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study Group: Experimental | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Usage | Opioid consumption data were collected and converted to oral morphine equivalents. | Postoperative day 4. |
| NRS Pain Scores at Rest | Patients rated pain on a scale of 0-10, with 0 representing no pain and 10 representing worst pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David H. Kim, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20048117 | Background | 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. | |
| 11138949 | Background | Bohannon RW. Measuring knee extensor muscle strength. Am J Phys Med Rehabil. 2001 Jan;80(1):13-8. doi: 10.1097/00002060-200101000-00004. |
| Label | URL |
|---|---|
| This is the link to the Hospital for Special Surgery home website. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | Saphenous (Adductor Canal) Nerve Block 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). |
| FG001 | Control | Femoral Nerve Block 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Saphenous (Adductor Canal) Nerve Block 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | kilogram-force | 48 hours following administration of anesthesia. |
|
4 days after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental | Saphenous (Adductor Canal) Nerve Block 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). |
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The duration of analgesia from the ACB block is unclear and was not measured. Also, a large follow-up study is needed to investigate whether ACB improves rehabilitation, incidence of falls, and/or length of hospital stay.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David H. Kim, MD | Hospital for Special Surgery | (212) 606-1206 | KimD@HSS.EDU |
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| ID | Term |
|---|---|
| D009407 | Nerve Block |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003714 | Denervation |
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|
|
| Control Group | Procedure | 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). |
|
|
| Postoperative day 4. |
| 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. |
| Incidence of Postoperative Complications. | Postoperative day 4. |
| Total Length of Hospital Stay | Total length of hospital stay |
| 10422923 | Background | 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. |
| 9661552 | Background | 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. |
| 19046884 | Background | 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. |
| 19920424 | Background | 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. |
| 18574578 | Background | 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. |
| BG001 | Control | Femoral Nerve Block 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Femoral Nerve Block 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). |
|
|
| Secondary | Total Opioid Usage | Opioid consumption data were collected and converted to oral morphine equivalents. | One patient was excluded from analysis due to a condition. Data from the remaining 93 patients were analyzed. | Posted | Mean | Standard Deviation | mg | 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. | One patient was excluded at the time of analysis, and the remaining 93 patients were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 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). | One patient was excluded from analysis, and the remaining 93 patients were included. | Posted | Mean | Standard Deviation | units on a scale | 24 hours following administration of anesthesia. |
|
|
|
| Secondary | Incidence of Postoperative Complications. | Posted | Count of Participants | Participants | Postoperative day 4. |
|
|
|
| Secondary | Total Length of Hospital Stay | Posted | Mean | Standard Deviation | days | Total length of hospital stay |
|
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | Control | Femoral Nerve Block 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). | 0 | 47 | 0 | 47 | 0 | 47 |
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| D019635 |
| Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |