Study of Different Concentrations of Epidural Bupivacaine for the Effects on Vasodilatation and Sensory Block

NCT00197353 | Completed Phase 3

• 1 other identifier: PPG1-ginosar-HMO-CTIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare human subjects receiving epidural bupivacaine local anesthetic at different doses and concentrations and to assess the effect on vasodilatation (sympathectomy), sensory and motor block. The hypothesis is that the drug concentration is more important than drug dose in the determination of the extent and intensity of differential sympathetic, sensory and motor block following epidural local anesthetic.

Conditions

Intraoperative Complications

Keywords

Anesthesia, Epidural; Pharmacology; Dose-Response Relationship, Drug; Sympathectomy; Photoplethysmography

Outcome Measures

Primary Outcomes (1)

• Index of sympathectomy: photoplethysmography derived amplitude-baseline ratio from foot and hand; data measured at time 0, 5, 10 and 20 min following epidural; data expressed as % change from baseline and as area under time effect curve.

Secondary Outcomes (8)

• 1. Other indices of sympathectomy:

• a. Photoplethysmography derived baseline change (ln (Blepi/Blo));

• b. Photoplethysmography derived time lag between pulse reaching hand and foot;

• c. Blood pressure (mean, systolic, diastolic);

• d. Skin temperature changes (finger and toe temperature change from baseline, toe-thigh and finger-arm temperature gradients).

Interventions

Epidural bupivacaine (dose/concentration/volume ranging) DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for extracorporeal shock wave lithotripsy (ESWL) under epidural anesthesia between March to September 1999

You may not qualify if:

• graded as ASA 3 or higher, below 18 or above 70 years of age, if they had peripheral vascular disease, baseline neurological deficit, or had any other contraindication for regional anesthesia.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Hebrew University Medical Center

Jerusalem, 91120, Israel

Location

Related Publications (3)

• Babchenko A, Davidson E, Ginosar Y, Kurz V, Faib I, Adler D, Nitzan M. Photoplethysmographic measurement of changes in total and pulsatile tissue blood volume, following sympathetic blockade. Physiol Meas. 2001 May;22(2):389-96. doi: 10.1088/0967-3334/22/2/310.

  PMID: 11411248 RESULT

• Ginosar Y, Weiniger CF, Meroz Y, Kurz V, Bdolah-Abram T, Babchenko A, Nitzan M, Davidson EM. Pulse oximeter perfusion index as an early indicator of sympathectomy after epidural anesthesia. Acta Anaesthesiol Scand. 2009 Sep;53(8):1018-26. doi: 10.1111/j.1399-6576.2009.01968.x. Epub 2009 Apr 24.

  PMID: 19397502 DERIVED

• Ginosar Y, Weiniger CF, Kurz V, Babchenko A, Nitzan M, Davidson E. Sympathectomy-mediated vasodilatation: a randomized concentration ranging study of epidural bupivacaine. Can J Anaesth. 2009 Mar;56(3):213-21. doi: 10.1007/s12630-008-9036-z. Epub 2009 Jan 28.

  PMID: 19247742 DERIVED

MeSH Terms

Conditions

Intraoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yehuda Ginosar, BSc MBBS

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: March 1, 1999
• Study Completion: September 1, 1999
• Last Updated: March 6, 2009

Record last verified: 2005-05

Locations

IL (1)