Clinical Characteristics of Spinal Levobupivacaine: Hyperbaric Compared With Isobaric Solution

November 5, 2013 updated by: Vimolluck Sanansilp, Mahidol University
The authors would like to investigate the blocking characteristics, surgical quality and side effects of intrathecal levobupivacaine whether there are any differences between the hyperbaric and the isobaric formulation for gynaecologic surgeries which need higher block level than the urological surgeries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators study in the similar patients, give the same intervention except the baricity of levobupivacaine. The investigators record the level of sensory block and modified Bromage score for motor blockade.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ASA I-III, aged 18-70 yr, scheduled for elective gynaecologic surgery, (total abdominal hysterectomy (TAH), TAH with uni-/bilateral salpingo-oophorectomy (SO), uni-/bilateral ovarian cystectomy, or myomectomy

Exclusion Criteria:

  • contraindications for spinal block, body mass index (BMI) more than 35 kg/m2 and height less than 150 cm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: isobaric levobupivacaine
spinal isobaric levobupivacaine
Drug: isobaric levobupivacaine
0.42% either isobaric levobupivacaine 3 ml spinal injection once
Other Names:
  • Chirocaine, Abbott Laboratories, Nycomed Pharma AS, Norway
Active Comparator: hyperbaric levobupivacaine
Drug: hyperbaric levobupivacaine
0.42% hyperbaric levobupivacaine 3 ml spinal injection once
Other Names:
  • Chirocaine, Abbott Laboratories, Nycomed Pharma AS, Norway

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to T4-dermatome sensory blockade
Time Frame: 30 minutes
to investigate specific blocking characteristics of intrathecal hyperbaric levobupivacaine compared with isobaric levobupivacaine for gynaecologic surgery
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
side effects
Time Frame: 1 to 4 hours intraoperation plus within 2 hours in the recovery room
to investigate side effects of intrathecal hyperbaric levobupivacaine compared with isobaric levobupivacaine for gynaecologic surgery
1 to 4 hours intraoperation plus within 2 hours in the recovery room

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Vimolluck - Sanansilp, MD, Dept of Anesthesiology, Faculty of Medicine Siriraj Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

May 5, 2011

First Submitted That Met QC Criteria

May 6, 2011

First Posted (Estimate)

May 9, 2011

Study Record Updates

Last Update Posted (Estimate)

November 7, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SiEC 197/2549

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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