Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00197353
Other study ID # PPG1-ginosar-HMO-CTIL
Secondary ID
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated March 5, 2009
Start date March 1999
Est. completion date September 1999

Study information

Verified date May 2005
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 1999
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Epidural bupivacaine (dose/concentration/volume ranging)


Locations

Country Name City State
Israel Hadassah Hebrew University Medical Center Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1. Other indices of sympathectomy:
Secondary a. Photoplethysmography derived baseline change (ln (Blepi/Blo));
Secondary b. Photoplethysmography derived time lag between pulse reaching hand and foot;
Secondary c. Blood pressure (mean, systolic, diastolic);
Secondary d. Skin temperature changes (finger and toe temperature change from baseline, toe-thigh and finger-arm temperature gradients).
Secondary 2. Sensory level (pinprick, touch, cold)
Secondary 3. Motor block (Bromage scale)
Secondary All assessments made at 0, 5, 10 and 20 minutes after epidural drug administration.
See also
  Status Clinical Trial Phase
Completed NCT04519203 - The Use of Surgical Pleth Index in Guiding Anesthesia in Gastroenterological Surgery N/A
Completed NCT02296619 - The Effects of Transversus Abdominis Plane Block in Patients Undergoing Total Abdominal Hysterectomy Phase 4
Completed NCT02043132 - Tranexamic Acid in Reverse Total Shoulder Arthroplasty Phase 2/Phase 3
Withdrawn NCT00861367 - Prospective Double-blind Study for the Use of Aspirin During Transurethral Surgery of the Bladder or the Prostate N/A
Completed NCT04517461 - Coagulation and Vitamin K in Head and Neck Microvascular Free Flap Surgery
Completed NCT02419053 - Evaluating the Effect of Surgical Safety Checklists on Perioperative Complications in Children N/A
Terminated NCT00308100 - Hydroxyethyl Starch (130/0.4) for Intravascular Volume Therapy in Liver Transplantation Phase 4
Active, not recruiting NCT04443465 - Patient Experiences of IONM and Outcomes
Recruiting NCT06426381 - The Effect of Therapeutic Touch Applied During Knee Replacement Surgery on Anxiety, Vital Signs and Comfort Level N/A
Completed NCT05550181 - Intraoperative Hypocapnia in PROVHILO and PROBESE
Completed NCT01664806 - Laparoscopic Cholecystectomy And Capacitive Coupling - Coag Versus Blend Mode Causing Thermal Injury at Port Site Skin Phase 3
Completed NCT00683293 - Clinical Trial Comparing Conventional and Robot-assisted(Da Vinci®)Laparoscopic Interventions for Hysterectomy N/A
Terminated NCT00364494 - Hemodilution and Outcome in Cardiac Surgery N/A
Completed NCT05136157 - Intravenous Bolus-infusion Versus Sliding Scale of Insulin for Intra-operative Glycemic Control Early Phase 1
Terminated NCT03665259 - Lower Inspiratory Oxygen Fraction for Preoxygenation N/A
Completed NCT02773199 - Effects of Preoperative Fasting on ECG and Vital Parameters N/A
Completed NCT03974321 - Intraoperative Hypotension and Perioperative Myocardial Injury
Enrolling by invitation NCT05270603 - The Intraoperative Complication Assessment and Reporting With Universal Standards - Calculator (ICARUS-C)
Completed NCT03467230 - Performance Assessment of the PMD-200 Under General Anesthesia
Recruiting NCT05276167 - Hyperthermic Intravesical Perfusion for Muscle-invasive Bladder Urothelial Carcinoma N/A