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NCT Number: NCT00197353

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

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.

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Key information

Conditions

Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hadassah Hebrew University Medical Center

Jerusalem, 91120, Israel

About this study

There is controversy regarding the factors that determine the extent and intensity of epidural drug action. Most studies have focused on the inter-related triad of dose, concentration and volume.

We compare three groups: group A: 10ml of 0.5% bupivacaine; group B: 10ml of 0.25% bupivacaine and group C: 40ml of 0.0625% bupivacaine. When comparing these groups, groups A & B have the same volume of epidural drug, and groups B & C have the same total dose.

In particular this study compares different methods of assessing the sympathetic block (causing vasodilatation). These methods include skin temperature changes, hemodynamic changes and photoplethysmography.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Epidural bupivacaine (dose/concentration/volume ranging)

Drug

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

  1. 1. Other indices of sympathectomy:

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

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

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

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

  6. 2. Sensory level (pinprick, touch, cold)

  7. 3. Motor block (Bromage scale)

  8. All assessments made at 0, 5, 10 and 20 minutes after epidural drug administration.

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

Sympathectomy-Mediated Vasodilatation and Differential Sensory Block After Epidural Bupivacaine: a Randomized Concentration Ranging Study

Important dates

Study start
1999
Study completion
1999
First posted
Sep 20, 2005
Registry last updated
Mar 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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