Peripheral Vascular Disease Clinical Trial
Official title:
Preoperative Continuous Sciatic Perineural Analgesia, as a Bridge Therapy for Ischemic Pain, in Patients Undergoing Lower Limb Revascularization: a Retrospective Descriptive Study
Verified date | May 2020 |
Source | Hospital Municipal Miguel Couto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study evaluates the pain score numerical rating, after sciatic analgesic continuous block, in patients with ischemic pain before surgery of limb revascularization. All patients received those blocks to control ischemic severe pain.
Status | Completed |
Enrollment | 15 |
Est. completion date | April 30, 2020 |
Est. primary completion date | April 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - preoperative continuous sciatic-popliteal nerve block - lower limb angioplasty - peripheral arterial disease; - between 2017 and 2018 years; - correct filling of numerical rating pain evaluation in the medical record Exclusion Criteria: - peripheral block to treat another pathology or condition in te same patient; - peripheral block at another concomitant site (other than the popliteal); - No adequate record of the care received in the medical record - if medical record is not available during the data collection period |
Country | Name | City | State |
---|---|---|---|
Brazil | Rafael M Linhares | Rio de Janeiro |
Lead Sponsor | Collaborator |
---|---|
Hospital Municipal Miguel Couto |
Brazil,
Aubuchon A, Arnold WD, Bracewell A, Hoyle JC. Sciatic neuropathy due to popliteal fossa nerve block. Muscle Nerve. 2017 Oct;56(4):822-824. doi: 10.1002/mus.25622. Epub 2017 Jun 6. — View Citation
Compère V, Cornet C, Fourdrinier V, Maitre AM, Duparc F, Biga N, Dureuil B. [Evaluation of continuous nerve block for postoperative pain management in orthopaedic surgery]. Ann Fr Anesth Reanim. 2005 Jul;24(7):795-801. French. — View Citation
Dao T, Amaro-Driedger D, Mehta J. Successful treatment of Raynaud's syndrome in a lupus patient with continuous bilateral popliteal sciatic nerve blocks: a case report. Local Reg Anesth. 2016 Jun 15;9:35-7. doi: 10.2147/LRA.S97111. eCollection 2016. — View Citation
Dingemans SA, de Ruiter KJ, Birnie MFN, Goslings JC, van Samkar G, Schepers T. Comparable Postoperative Pain Levels Using 2 Different Nerve Blocks in the Operative Treatment of Displaced Intra-articular Calcaneal Fractures. Foot Ankle Int. 2017 Dec;38(12):1352-1356. doi: 10.1177/1071100717730337. Epub 2017 Sep 16. — View Citation
Gelfand HJ, Ouanes JP, Lesley MR, Ko PS, Murphy JD, Sumida SM, Isaac GR, Kumar K, Wu CL. Analgesic efficacy of ultrasound-guided regional anesthesia: a meta-analysis. J Clin Anesth. 2011 Mar;23(2):90-6. doi: 10.1016/j.jclinane.2010.12.005. — View Citation
Joshi G, Gandhi K, Shah N, Gadsden J, Corman SL. Peripheral nerve blocks in the management of postoperative pain: challenges and opportunities. J Clin Anesth. 2016 Dec;35:524-529. doi: 10.1016/j.jclinane.2016.08.041. Epub 2016 Oct 20. Review. — View Citation
Kim NY, Lee KY, Bai SJ, Hong JH, Lee J, Park JM, Kim SH. Comparison of the effects of remifentanil-based general anesthesia and popliteal nerve block on postoperative pain and hemodynamic stability in diabetic patients undergoing distal foot amputation: A retrospective observational study. Medicine (Baltimore). 2016 Jul;95(29):e4302. doi: 10.1097/MD.0000000000004302. — View Citation
Luiten WE, Schepers T, Luitse JS, Goslings JC, Hermanides J, Stevens MF, Hollmann MW, van Samkar G. Comparison of continuous nerve block versus patient-controlled analgesia for postoperative pain and outcome after talar and calcaneal fractures. Foot Ankle Int. 2014 Nov;35(11):1116-21. doi: 10.1177/1071100714546640. Epub 2014 Aug 12. — View Citation
Thomas K, Barrett B, Tupper R, Dacenko-Grawe L, Holm K. Pain management after total knee arthroplasty: a case–control study of continuous nerve block therapy. Orthop Nurs. 2014 Sep-Oct;33(5):268-76. doi: 10.1097/NOR.0b013e3182879bd9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in numerical pain scale | Numerical Pain Scale (END) self-assessed by the patient before and after 24 hours of continuous analgesic block of the sciatic nerve, with infusion of levobupivacaine 0,125% or ropivacaine 0,2%. The scale score is 0-10 (0= no pain; 10 = pain as bad as can be) | 24 hours after placement of sciatic catheter | |
Secondary | change in numerical pain scale | Numerical Pain Scale (END) self-assessed by the patient before and after 72 hours of continuous analgesic block of the sciatic nerve, with infusion of levobupivacaine 0,125% or ropivacaine 0,2%. The scale score is 0-10 (0= no pain; 10 = pain as bad as can be) | 72 hours after placement of sciatic catheter | |
Secondary | classification of technique difficulties | To report, qualitatively, the presence of variations or difficulties in the use of the technique, such as: failure of the technique (FT); existence of concomitant venous analgesia (VA); inadequate registration of the technique (IR) | 72 hours after placement of sciatic catheter | |
Secondary | classifications of possible complications | Report, qualitatively, the presence of possible complications, such as: hyperemia of the catheter insertion site (HC); the presence of pus (PUS); catheter displacement (CD) | 72 hours after placement of sciatic catheter |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05335525 -
Post-market Clinical Investigation of the Angio-Seal™ VIP VCD (ANGIO-SEAL CLOSE)
|
||
Active, not recruiting |
NCT01903044 -
Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating
|
Phase 1/Phase 2 | |
Completed |
NCT02228564 -
BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease
|
N/A | |
Completed |
NCT02271529 -
Zilver PTX Delivery System
|
N/A | |
Recruiting |
NCT02054871 -
RCT to Evaluate the Renal Protective Effects of Remote Ischaemic Preconditioning in Peripheral Angioplasty
|
N/A | |
Completed |
NCT00822172 -
Evaluation of Cilostazol in Combination With L-Carnitine
|
Phase 4 | |
Completed |
NCT00574782 -
Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE)
|
N/A | |
Completed |
NCT00029991 -
Extract of Ginkgo Biloba (EGB 761) and Vascular Function
|
Phase 1/Phase 2 | |
Completed |
NCT01355406 -
Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System
|
N/A | |
Recruiting |
NCT05804097 -
Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?
|
Phase 4 | |
Recruiting |
NCT03638115 -
The VaSecure BTK Study
|
N/A | |
Active, not recruiting |
NCT03241459 -
Safety and Efficacy of the SurVeil™ Drug-Coated Balloon
|
N/A | |
Active, not recruiting |
NCT01661231 -
Study to Determine the Performance of the Astron and Pulsar-18 Stents in Europe
|
N/A | |
Completed |
NCT01722877 -
JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions
|
N/A | |
Completed |
NCT01444378 -
Absolute Pro® MOMENTUM™
|
N/A | |
Completed |
NCT00753337 -
The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study
|
N/A | |
Completed |
NCT00538226 -
Evaluation of the Effect of the Flowaid Device in Increasing Local Circulation in the Leg
|
Phase 1 | |
Completed |
NCT00593385 -
Atrium iCAST Iliac Stent Pivotal Study
|
N/A | |
Recruiting |
NCT00385385 -
RESTORE-IT-Study of Rifalazil in Chlamydia Pneumoniae Seropositive Patients With a History of Atherosclerotic Disease
|
Phase 2 | |
Completed |
NCT00392509 -
ALD-301 for Critical Limb Ischemia, Randomized Trial
|
Phase 1/Phase 2 |