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No further enrolled patients, Primary researcher left the institution
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This study aims to determine if there is any difference in the success rate of ultra-sound guided femoral nerve block performed with an echogenic needle versus a standard needle.
To date, the published information regarding ultrasound guided femoral nerve blocks (FNB) using echo friendly needle is very limited. More so, there is even less information regarding ultrasound guided nerve blocks using echogenic versus standard of care needles.
This study hopes to add to the general knowledge of pain management in the emergency department (ED) setting and provide a unique perspective on ultrasound-guided techniques using echogenic needles to enhance accuracy and success rate of nerve blocks in ED patients.
The study design will have two comparative arms; in both arms we use the same local anesthetic which is Bupivacaine 0.25% with epinephrine; in all cases a total of 15 mL will be injected around the femoral nerve. Once identified with ultrasound, 5 ml will be injected at lateral, medial, and posterior aspect of the nerve. The experimental arm will receive an FNB using an echogenic needle; and the control group will receive an FNB using standard of care needles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Echogenic needle | Experimental | The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible. |
|
| Standard of care needle | Active Comparator | The control group will receive ultrasound-guided femoral nerve block using standard of care needles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femoral Nerve Block | Drug | Femoral Nerve Block for isolated femur fractures |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Pain Level | Pain level will be measured on a numeric visual analogue scale of 0-10 with 0 being no pain and 10 being the worst pain ever. | baseline |
| Patient Pain Level | Pain level will be measured on a numeric visual analogue scale of 0-10 with 0 being no pain and 10 being the worst pain ever. | 60 minutes after initial femoral block |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos J Roldan, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyndon Baines Johnson General Hospital | Houston | Texas | 77026 | United States | ||
| Memorial Hermann Hospital Texas Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20006206 | Background | Beaudoin FL, Nagdev A, Merchant RC, Becker BM. Ultrasound-guided femoral nerve blocks in elderly patients with hip fractures. Am J Emerg Med. 2010 Jan;28(1):76-81. doi: 10.1016/j.ajem.2008.09.015. | |
| 18358935 | Background | Bijur P, Berard A, Nestor J, Calderon Y, Davitt M, Gallagher EJ. No racial or ethnic disparity in treatment of long-bone fractures. Am J Emerg Med. 2008 Mar;26(3):270-4. doi: 10.1016/j.ajem.2007.05.010. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Echogenic Needle | The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible. Femoral Nerve Block: Femoral Nerve Block for isolated femur fractures Echogenic needle: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible. Ultrasound: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible. The control group will receive ultrasound-guided femoral nerve block using standard of care needles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Echogenic needle | Device | The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible. |
|
| Standard of care needle | Device | The control group will receive ultrasound-guided femoral nerve block using standard of care needles. |
|
| Ultrasound | Device | The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible. The control group will receive ultrasound-guided femoral nerve block using standard of care needles. |
|
| Houston |
| Texas |
| 77030 |
| United States |
| 17214918 | Background | Brull R, Perlas A, Chan VW. Ultrasound-guided peripheral nerve blockade. Curr Pain Headache Rep. 2007 Feb;11(1):25-32. doi: 10.1007/s11916-007-0018-6. |
| 18020079 | Background | Deam RK, Kluger R, Barrington MJ, McCutcheon CA. Investigation of a new echogenic needle for use with ultrasound peripheral nerve blocks. Anaesth Intensive Care. 2007 Aug;35(4):582-6. doi: 10.1177/0310057X0703500419. |
| 12548273 | Background | Fletcher AK, Rigby AS, Heyes FL. Three-in-one femoral nerve block as analgesia for fractured neck of femur in the emergency department: a randomized, controlled trial. Ann Emerg Med. 2003 Feb;41(2):227-33. doi: 10.1067/mem.2003.51. |
| 7593107 | Background | Haddad FS, Williams RL. Femoral nerve block in extracapsular femoral neck fractures. J Bone Joint Surg Br. 1995 Nov;77(6):922-3. |
| 22915864 | Background | Iamaroon A, Raksakietisak M, Halilamien P, Hongsawad J, Boonsararuxsapong K. Femoral nerve block versus fentanyl: Analgesia for positioning patients with fractured femur. Local Reg Anesth. 2010;3:21-6. doi: 10.2147/lra.s8600. Epub 2010 Mar 25. |
| 14525749 | Background | Lee JS, Hobden E, Stiell IG, Wells GA. Clinically important change in the visual analog scale after adequate pain control. Acad Emerg Med. 2003 Oct;10(10):1128-30. doi: 10.1111/j.1553-2712.2003.tb00586.x. |
| 17456684 | Background | Marhofer P, Chan VW. Ultrasound-guided regional anesthesia: current concepts and future trends. Anesth Analg. 2007 May;104(5):1265-9, tables of contents. doi: 10.1213/01.ane.0000260614.32794.7b. |
| 9840855 | Background | Marhofer P, Schrogendorfer K, Wallner T, Koinig H, Mayer N, Kapral S. Ultrasonographic guidance reduces the amount of local anesthetic for 3-in-1 blocks. Reg Anesth Pain Med. 1998 Nov-Dec;23(6):584-8. doi: 10.1016/s1098-7339(98)90086-4. |
| 9322469 | Background | Marhofer P, Schrogendorfer K, Koinig H, Kapral S, Weinstabl C, Mayer N. Ultrasonographic guidance improves sensory block and onset time of three-in-one blocks. Anesth Analg. 1997 Oct;85(4):854-7. doi: 10.1097/00000539-199710000-00026. |
| 8015121 | Background | Moher D, Dulberg CS, Wells GA. Statistical power, sample size, and their reporting in randomized controlled trials. JAMA. 1994 Jul 13;272(2):122-4. |
| 18829935 | Background | Mutty CE, Jensen EJ, Manka MA Jr, Anders MJ, Bone LB. Femoral nerve block for diaphyseal and distal femoral fractures in the emergency department. Surgical technique. J Bone Joint Surg Am. 2008 Oct;90 Suppl 2 Pt 2:218-26. doi: 10.2106/JBJS.H.00314. |
| 20345356 | Background | Saygi B, Ozkan K, Eceviz E, Tetik C, Sen C. Skin traction and placebo effect in the preoperative pain control of patients with collum and intertrochanteric femur fractures. Bull NYU Hosp Jt Dis. 2010;68(1):15-7. |
| 20642733 | Background | Terrell KM, Hui SL, Castelluccio P, Kroenke K, McGrath RB, Miller DK. Analgesic prescribing for patients who are discharged from an emergency department. Pain Med. 2010 Jul;11(7):1072-7. doi: 10.1111/j.1526-4637.2010.00884.x. |
| 7074406 | Background | Tondare AS, Nadkarni AV. Femoral nerve block for fractured shaft of femur. Can Anaesth Soc J. 1982 May;29(3):270-1. doi: 10.1007/BF03007129. |
| FG001 | Standard of Care Needle | The control group will receive ultrasound-guided femoral nerve block using standard of care needles. Femoral Nerve Block: Femoral Nerve Block for isolated femur fractures Standard of care needle: The control group will receive ultrasound-guided femoral nerve block using standard of care needles. Ultrasound: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible. The control group will receive ultrasound-guided femoral nerve block using standard of care needles. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Echogenic Needle | The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible. Femoral Nerve Block: Femoral Nerve Block for isolated femur fractures Echogenic needle: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible. Ultrasound: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible. The control group will receive ultrasound-guided femoral nerve block using standard of care needles. |
| BG001 | Standard of Care Needle | The control group will receive ultrasound-guided femoral nerve block using standard of care needles. Femoral Nerve Block: Femoral Nerve Block for isolated femur fractures Standard of care needle: The control group will receive ultrasound-guided femoral nerve block using standard of care needles. Ultrasound: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible. The control group will receive ultrasound-guided femoral nerve block using standard of care needles. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| 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 | Patient Pain Level | Pain level will be measured on a numeric visual analogue scale of 0-10 with 0 being no pain and 10 being the worst pain ever. | Posted | Mean | Standard Deviation | units on a scale | baseline |
|
|
| |||||||||||||||||||||||||||||
| Primary | Patient Pain Level | Pain level will be measured on a numeric visual analogue scale of 0-10 with 0 being no pain and 10 being the worst pain ever. | Posted | Mean | Standard Deviation | units on a scale | 60 minutes after initial femoral block |
|
Length of stay in Emergency Department (about 5 hours)
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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 | Echogenic Needle | The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible. Femoral Nerve Block: Femoral Nerve Block for isolated femur fractures Echogenic needle: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible. Ultrasound: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible. The control group will receive ultrasound-guided femoral nerve block using standard of care needles. | 0 | 4 | 0 | 4 | ||
| EG001 | Standard of Care Needle | The control group will receive ultrasound-guided femoral nerve block using standard of care needles. Femoral Nerve Block: Femoral Nerve Block for isolated femur fractures Standard of care needle: The control group will receive ultrasound-guided femoral nerve block using standard of care needles. Ultrasound: The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible. The control group will receive ultrasound-guided femoral nerve block using standard of care needles. | 0 | 8 | 0 | 8 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carlos J Roldan, MD | The University of Texas Health Science Center at Houston | 713-745-7246 | Carlos.J.Roldan@uth.tmc.edu |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Male |
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