Ischemic Pain Control With Analgesic Methods Clinical Trial (ISCHAEMIC)

• ClinicalTrials.gov Identifier: NCT02841488
• Recruitment Status: Unknown
• First Posted: July 22, 2016
• Last Update Posted: July 22, 2016
• Sponsor: University of Sao Paulo General Hospital
• Information provided by (Responsible Party): Hermann dos Santos Fernandes, University of Sao Paulo General Hospital

Tracking Information

• First Submitted Date: July 17, 2016
• First Posted Date: July 22, 2016
• Last Update Posted Date: July 22, 2016
• Study Start Date: September 2016
• Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 21, 2016)

Pain intensity [ Time Frame: up to 28th day ]

Verbal numerical scale

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 21, 2016)

Opioids Adverse effects [ Time Frame: up to 28th day ]

Nausea, vomiting, constipation, sedation

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ischemic Pain Control With Analgesic Methods Clinical Trial
• 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

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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Arterial Occlusive Diseases

Intervention

• Procedure: Continuous peripheral sciatic nerve block
  Continuous infusion of local anesthetics through perineural sciatic nerve catheter
  Other Name: Perineural sciatic catheter
• Drug: Fentanyl
  Use of patient controlled analgesia device with intravenous fentanyl
  Other Name: Intravenous fentanyl
• Drug: Ropivacaine
• Device: Perineural catheter

Study Arms

• Active Comparator: Continuous nerve block
  Continuous peripheral sciatic nerve block through popliteal perineural catheter with ropivacaine
  Interventions:

  • Procedure: Continuous peripheral sciatic nerve block
  • Drug: Ropivacaine
  • Device: Perineural catheter
• Active Comparator: Systemic analgesia
  Intravenous fentanyl patient controlled analgesia device
  Intervention: Drug: Fentanyl

Publications *

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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 21, 2016): 56
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2018
• Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)

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 .

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02841488
• Other Study ID Numbers: CAAE: 55187516.4.0000.0068
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Hermann dos Santos Fernandes, University of Sao Paulo General Hospital
• Study Sponsor: University of Sao Paulo General Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Joaquim E Vieira, PhD; Professor

• PRS Account: University of Sao Paulo General Hospital
• Verification Date: July 2016