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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Technique Left Leg, Control Technique Right Leg | Experimental |
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| Study Technique Right Leg, Control Technique Left Leg | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study Technique | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tracking Total Opioid Usage | Up to postoperative day 2 | |
| Preoperative and Postoperative Thigh Muscle Strength in Both Legs | This was measured with a dynamometer to gauge strength. | Up to postoperative day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stavros G. Memtsoudis, MD, PhD | 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 |
|---|---|---|---|
| 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. | |
| 16135349 | Background | 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. |
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Patients were excluded prior to randomization if they had contraindications to spinal or epidural anesthesia, had chronic opioid use, pre-existing neuropathies in the limbs, allergies to pre-operative medications, contraindication to assigned nerve blocks, allergy to local anesthetic, American Society of Anesthesia 4-5, and non-English speaking.
Recruitment was from the period of 4/16/12-9/4/13 at the Hospital for Special Surgery. Patients were identified on the day of surgery and randomized prior to the start of surgery.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Technique Right Leg, Control Technique Left Leg | |
| FG001 | Study Technique Left Leg, Control Technique Right Leg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age |
| 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 | 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. | Posted | Mean | Standard Deviation | units on a scale | Up to postoperative day 1 |
|
The study was monitored for adverse events over the course of 1 year.
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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 | Study Technique: Saphenous Nerve Block |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epidural failure | General disorders | Epidural pump for patient malfunctioned |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stavros G. Memtsoudis, MD, PhD | Hospital for Special Surgery | 212-606-1206 | memtsoudiss@hss.edu |
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|
| Control Technique | Procedure | 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. |
|
| Patient Satisfaction With Nerve Blocks | Rated on a 0-10 scale, with a higher score representing greater satisfaction. | 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 |
| Postoperative Complications | Up to postoperative day 2 |
| 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. |
| 19916251 | Background | 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. |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Control Technique: The other leg will receive the femoral nerve block. 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. |
|
|
| Secondary | Tracking Total Opioid Usage | Posted | Mean | Standard Deviation | milligrams | Up to postoperative day 2 |
|
|
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| Secondary | Preoperative and Postoperative Thigh Muscle Strength in Both Legs | This was measured with a dynamometer to gauge strength. | Posted | Mean | Standard Deviation | kilogram-force unit | Up to postoperative day 2 |
|
|
|
| Secondary | Patient Satisfaction With Nerve Blocks | Rated on a 0-10 scale, with a higher score representing greater satisfaction. | Posted | Mean | Standard Deviation | units on a scale | Up to postoperative day 1 |
|
|
|
| Secondary | Duration of Motor and Sensory Blockade | The duration of motor and sensory blockade was not calculated and analyzed, because accurate data regarding block resolution time could not be acquired from patients. | Posted | Up to postoperative day 2 |
|
|
| Secondary | Rating the Success of the Nerve Blocks | The success of nerve blocks was not collected or analyzed. Instead, muscle strength was collected (data are presented in another table). | Posted | Up to postoperative day 2 |
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| Secondary | Postoperative Complications | Analysis of postoperative complications was not performed because sufficient data could not be collected regarding the secondary outcome | Posted | Up to postoperative day 2 |
|
|
| 0 |
| 60 |
| 1 |
| 60 |
| EG001 | Control Technique: Femoral Nerve Block | 0 | 60 | 0 | 60 |
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| 24 h postoperative |
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| 48 postoperative |
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