Intraoperative ComplicationsPhase 3NCT00197353
Study of Different Concentrations of Epidural Bupivacaine for the Effects on Vasodilatation and Sensory Block
A Phase 3 study testing Epidural bupivacaine (dose/concentration/volume ranging) in people with Intraoperative Complications, run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intraoperative Complications
- What is being tested?
- Epidural bupivacaine (dose/concentration/volume ranging)
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 1999to Sep 1999
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for extracorporeal shock wave lithotripsy (ESWL) under epidural anesthesia between March to September 1999
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sympathectomy-Mediated Vasodilatation and Differential Sensory Block After Epidural Bupivacaine: a Randomized Concentration Ranging Study
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.
Read the detailed 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.
- Conditions
- Intraoperative Complications
- Being tested
- Epidural bupivacaine (dose/concentration/volume ranging)
- Keywords
- Anesthesia, Epidural, Pharmacology, Dose-Response Relationship, Drug, Sympathectomy, Photoplethysmography
- Medical subject headings
- Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural bupivacaine (dose/concentration/volume ranging)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
2. Sensory level (pinprick, touch, cold)
3. Motor block (Bromage scale)
All assessments made at 0, 5, 10 and 20 minutes after epidural drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 1999
- Study completionSep 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intraoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Yehuda Ginosar, BSc MBBS, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197353
- Sponsor's protocol ID
- PPG1-ginosar-HMO-CTIL
- Status last verified
- May 2005
- First submitted
- 13 Sep 2005
- Last updated
- 6 Mar 2009
- Results posted
- No
Publications
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.
PubMed 11411248Ginosar 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.
PubMed 19397502Ginosar 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.
PubMed 19247742
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sympathectomy-Mediated Vasodilatation and Differential Sensory Block After Epidural Bupivacaine: a Randomized Concentration Ranging Study
- ClinicalTrials.gov ID
- NCT00197353
- Acronym / sponsor ID
- PPG1-ginosar-HMO-CTIL
- Conditions
- Intraoperative Complications
- Keywords
- Anesthesia, Epidural, Pharmacology, Dose-Response Relationship, Drug, Sympathectomy, Photoplethysmography
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Mar 1999
- Study completion
- Sep 1999
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for extracorporeal shock wave lithotripsy (ESWL) under epidural anesthesia between March to September 1999
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural bupivacaine (dose/concentration/volume ranging) | Drug | – |
Primary outcome
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.
8 secondary outcomes
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).
2. Sensory level (pinprick, touch, cold)
3. Motor block (Bromage scale)
All assessments made at 0, 5, 10 and 20 minutes after epidural drug administration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2009.
- Results publication: PubMed 11411248Babchenko 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.
- Derived from this study: PubMed 19397502Ginosar 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.
- Derived from this study: PubMed 19247742Ginosar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yehuda Ginosar, BSc MBBS principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epidural bupivacaine (dose/concentration/volume ranging) in people with Intraoperative Complications, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00197353, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2009.