Ischemic Pain Control With Analgesic Methods Clinical Trial (ISCHAEMIC)
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|ClinicalTrials.gov Identifier: NCT02841488|
Recruitment Status : Unknown
Verified July 2016 by Hermann dos Santos Fernandes, University of Sao Paulo General Hospital.
Recruitment status was: Not yet recruiting
First Posted : July 22, 2016
Last Update Posted : July 22, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Arterial Occlusive Diseases||Procedure: Continuous peripheral sciatic nerve block Drug: Fentanyl Drug: Ropivacaine Device: Perineural catheter||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||October 2018|
Active Comparator: Continuous nerve block
Continuous peripheral sciatic nerve block through popliteal perineural catheter with ropivacaine
Procedure: Continuous peripheral sciatic nerve block
Continuous infusion of local anesthetics through perineural sciatic nerve catheter
Other Name: Perineural sciatic catheter
Device: Perineural catheter
Active Comparator: Systemic analgesia
Intravenous fentanyl patient controlled analgesia device
Use of patient controlled analgesia device with intravenous fentanyl
Other Name: Intravenous fentanyl
- Pain intensity [ Time Frame: up to 28th day ]Verbal numerical scale
- Opioids Adverse effects [ Time Frame: up to 28th day ]Nausea, vomiting, constipation, sedation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841488
|Contact: Hermann S Fernandes, MD||+55 84 firstname.lastname@example.org|
|Contact: Hazem A Ashmawi, PhD||+55 11 email@example.com|
|Principal Investigator:||Joaquim E Vieira, PhD||Professor|