Ischemic Pain Control With Analgesic Methods Clinical Trial

NCT ID: NCT02841488

Last Updated: 2016-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-10-31

Brief 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.

Detailed 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.

Conditions

Arterial Occlusive Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Continuous nerve block

Continuous peripheral sciatic nerve block through popliteal perineural catheter with ropivacaine

Group Type: ACTIVE_COMPARATOR

Continuous peripheral sciatic nerve block

Intervention Type: PROCEDURE

Continuous infusion of local anesthetics through perineural sciatic nerve catheter

Ropivacaine

Intervention Type: DRUG

Perineural catheter

Intervention Type: DEVICE

Systemic analgesia

Intravenous fentanyl patient controlled analgesia device

Group Type: ACTIVE_COMPARATOR

Fentanyl

Intervention Type: DRUG

Use of patient controlled analgesia device with intravenous fentanyl

Interventions

Continuous peripheral sciatic nerve block

Continuous infusion of local anesthetics through perineural sciatic nerve catheter

Intervention Type: PROCEDURE

Fentanyl

Use of patient controlled analgesia device with intravenous fentanyl

Intervention Type: DRUG

Ropivacaine

Intervention Type: DRUG

Perineural catheter

Intervention Type: DEVICE

Other Intervention Names

Perineural sciatic catheter; Intravenous fentanyl

Eligibility Criteria

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 .

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hermann dos Santos Fernandes

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joaquim E Vieira, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Central Contacts

Hermann S Fernandes, MD

Role: CONTACT

hermann.fernandes@hc.fm.usp.br

+55 84 988966348

Hazem A Ashmawi, PhD

Role: CONTACT

hazem.ashmawi@hc.fm.usp.br

+55 11 985733798

References

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.

Reference Type: BACKGROUND

PMID: 15262830 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15184277 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12719196 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2673321 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9844701 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11068220 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21821511 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18784489 (View on PubMed)

Study Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

CAAE: 55187516.4.0000.0068

Identifier Type: -

Identifier Source: org_study_id