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This project is one of four components of a thematic project that aims to evaluate the use of ultrasound in regional blocks, called "Use of ultrasound in regional blocks and injections for the treatment of acute and chronic pain."
It will evaluate quantitative and qualitative control of ischemic pain in the lower limbs in patients with peripheral arterial occlusive disease through continuous sciatic nerve block by perineural catheter, popliteal approach, compared to systemic analgesia based on opioids.
BACKGROUND: Peripheral arterial occlusive disease (PAOD) commonly evolves with intense ischemic pain in the lower limbs, which is hard to control with systemic analgesics, and continuous regional anesthesia may be an alternative, with adequate analgesia and lower incidence of side effects.
OBJECTIVES: evaluate qualitative and quantitative pain control, incidence of adverse effects and operative results in patients with PAOD undergoing continuous anesthetic blockade of the sciatic nerve by perineural catheter compared to systemic analgesia based on opioids and adjuvant medications.
METHODS: It is a randomized clinical trial, covered for evaluators. It will include 56 patients with PAOD Fontaine IV, with pain by the presence of ulcerations located on foot. A group will be submitted to continuous regional anesthesia of sciatic nerve through perineural catheter and another group will have its pain control through patient controlled analgesia device with intravenous fentanyl. The primary dependent variable will be pain, through the numerical pain scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous nerve block | Active Comparator | Continuous peripheral sciatic nerve block through popliteal perineural catheter with ropivacaine |
|
| Systemic analgesia | Active Comparator | Intravenous fentanyl patient controlled analgesia device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous peripheral sciatic nerve block | Procedure | Continuous infusion of local anesthetics through perineural sciatic nerve catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Verbal numerical scale | up to 28th day |
| Measure | Description | Time Frame |
|---|---|---|
| Opioids Adverse effects | Nausea, vomiting, constipation, sedation | up to 28th day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hermann S Fernandes, MD | Contact | +55 84 988966348 | hermann.fernandes@hc.fm.usp.br | |
| Hazem A Ashmawi, PhD | Contact | +55 11 985733798 | hazem.ashmawi@hc.fm.usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Joaquim E Vieira, PhD | Professor | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15262830 | Background | Selvin E, Erlinger TP. Prevalence of and risk factors for peripheral arterial disease in the United States: results from the National Health and Nutrition Examination Survey, 1999-2000. Circulation. 2004 Aug 10;110(6):738-43. doi: 10.1161/01.CIR.0000137913.26087.F0. Epub 2004 Jul 19. | |
| 15184277 | Background |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Informed Consent Form | View IPD |
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| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000813 | Anilides |
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| Fentanyl | Drug | Use of patient controlled analgesia device with intravenous fentanyl |
|
|
| Ropivacaine | Drug |
|
| Perineural catheter | Device |
|
| Navas-Acien A, Selvin E, Sharrett AR, Calderon-Aranda E, Silbergeld E, Guallar E. Lead, cadmium, smoking, and increased risk of peripheral arterial disease. Circulation. 2004 Jun 29;109(25):3196-201. doi: 10.1161/01.CIR.0000130848.18636.B2. Epub 2004 Jun 7. |
| 12719196 | Background | Belch JJ, Topol EJ, Agnelli G, Bertrand M, Califf RM, Clement DL, Creager MA, Easton JD, Gavin JR 3rd, Greenland P, Hankey G, Hanrath P, Hirsch AT, Meyer J, Smith SC, Sullivan F, Weber MA; Prevention of Atherothrombotic Disease Network. Critical issues in peripheral arterial disease detection and management: a call to action. Arch Intern Med. 2003 Apr 28;163(8):884-92. doi: 10.1001/archinte.163.8.884. No abstract available. |
| 2673321 | Background | McDaniel MD, Cronenwett JL. Basic data related to the natural history of intermittent claudication. Ann Vasc Surg. 1989 Jul;3(3):273-7. doi: 10.1016/S0890-5096(07)60040-5. No abstract available. |
| 9844701 | Background | Marquis P, Lecasble M, Passa P. [Quality of life of patient with peripheral arterial obliterative disease treated with ifenprodil tartrate. Results of an ARTEMIS study]. Drugs. 1998;56 Suppl 3:37-48. doi: 10.2165/00003495-199856003-00005. French. |
| 11068220 | Background | Campbell WB, Marriott S, Eve R, Mapson E, Sexton S, Thompson JF. Anaesthesia and analgesia for major lower limb amputation. Cardiovasc Surg. 2000 Dec;8(7):572-5. doi: 10.1016/s0967-2109(00)00071-5. |
| 21821511 | Background | Ilfeld BM. Continuous peripheral nerve blocks: a review of the published evidence. Anesth Analg. 2011 Oct;113(4):904-25. doi: 10.1213/ANE.0b013e3182285e01. Epub 2011 Aug 4. |
| 18784489 | Background | Capdevila X, Ponrouch M, Choquet O. Continuous peripheral nerve blocks in clinical practice. Curr Opin Anaesthesiol. 2008 Oct;21(5):619-23. doi: 10.1097/ACO.0b013e32830c66c2. |
| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |