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Clinical Characteristics of Spinal Levobupivacaine: Hyperbaric Compared With Isobaric Solution

NCT ID: NCT01349751

Last Updated: 2013-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Observation of Neuromuscular Block Disease (or Disorder); Gynecological

Keywords

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abdominal incision hyperbaric isobaric levobupivacaine spinal anaesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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isobaric levobupivacaine

spinal isobaric levobupivacaine

Group Type ACTIVE_COMPARATOR

isobaric levobupivacaine

Intervention Type DRUG

0.42% either isobaric levobupivacaine 3 ml spinal injection once

hyperbaric levobupivacaine

hyperbaric levobupivacaine

Group Type ACTIVE_COMPARATOR

hyperbaric levobupivacaine

Intervention Type DRUG

0.42% hyperbaric levobupivacaine 3 ml spinal injection once

Interventions

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isobaric levobupivacaine

0.42% either isobaric levobupivacaine 3 ml spinal injection once

Intervention Type DRUG

hyperbaric levobupivacaine

0.42% hyperbaric levobupivacaine 3 ml spinal injection once

Intervention Type DRUG

Other Intervention Names

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Chirocaine, Abbott Laboratories, Nycomed Pharma AS, Norway Chirocaine, Abbott Laboratories, Nycomed Pharma AS, Norway

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Vimolluck Sanansilp

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vimolluck - Sanansilp, MD

Role: PRINCIPAL_INVESTIGATOR

Dept of Anesthesiology, Faculty of Medicine Siriraj Hospital

Locations

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Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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SiEC 197/2549

Identifier Type: -

Identifier Source: org_study_id