Ischemic Pain Control With Analgesic Methods Clinical Trial

Arterial Occlusive Diseases Clinical Trial

— ISCHAEMIC  

Official title:

Comparative Study Between Systemic Analgesia and Continuous Sciatic Nerve Block in Patients With Chronic Obstructive Arterial Disease and Ischemic Pain in Lower Limbs

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02841488
• Other study ID #: CAAE: 55187516.4.0000.0068
• Status: Not yet recruiting
• Phase: Phase 3
• First received: July 17, 2016
• Last updated: July 21, 2016
• Start date: September 2016
• Est. completion date: October 2018

Study information

• Verified date: July 2016
• Source: University of Sao Paulo General Hospital
• Contact: Hermann S Fernandes, MD
• Phone: +55 84 988966348
• Email: hermann.fernandes[@]hc.fm.usp.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: October 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 18 years old who have strong or moderate persistent ischemic pain in the lower limbs, due to peripheral artery occlusive disease, classified as Fontaine IV (pain at rest and presence of ulcer or gangrene).

Exclusion Criteria:

• Uncooperative patients, coagulation disorders, patients with liver failure, who have atrioventricular block second or third degree, who refuse to be submitted to peripheral nerve block, with systemic or procedure site local infection infection, peripheral or central neuropathy history, allergies to local anesthetics or to any of the drugs to be used in the study and difficulty in understanding the use of the PCA (patient-controlled analgesia) device and evaluation methods used in the study .

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Diseases

Intervention

Procedure:
• Continuous peripheral sciatic nerve block
Continuous infusion of local anesthetics through perineural sciatic nerve catheter

Drug:
• Fentanyl
Use of patient controlled analgesia device with intravenous fentanyl
• Ropivacaine

Device:
• Perineural catheter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

References & Publications (8)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. French. — View Citation

McDaniel MD, Cronenwett JL. Basic data related to the natural history of intermittent claudication. Ann Vasc Surg. 1989 Jul;3(3):273-7. Review. — View Citation

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. Epub 2004 Jun 7. — View Citation

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. Epub 2004 Jul 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Verbal numerical scale	up to 28th day	No
Secondary	Opioids Adverse effects	Nausea, vomiting, constipation, sedation	up to 28th day	No