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Clinical Characteristics of Spinal Levobupivacaine: Hyperbaric Compared With Isobaric Solution

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ClinicalTrials.gov Identifier: NCT01349751
Recruitment Status : Completed
First Posted : May 9, 2011
Last Update Posted : November 7, 2013
Sponsor:
Information provided by (Responsible Party):
Vimolluck Sanansilp, Mahidol University

Brief Summary:
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.

Condition or disease Intervention/treatment
Observation of Neuromuscular Block Disease (or Disorder); Gynecological Drug: isobaric levobupivacaine Drug: hyperbaric levobupivacaine

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  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Clinical Characteristics of Spinal Levobupivacaine: Hyperbaric Compared With Isobaric Solution
Study Start Date : January 2007
Primary Completion Date : February 2008
Study Completion Date : February 2008

Arm Intervention/treatment
Active Comparator: isobaric levobupivacaine
spinal isobaric levobupivacaine
Drug: isobaric levobupivacaine
0.42% either isobaric levobupivacaine 3 ml spinal injection once
Other Name: Chirocaine, Abbott Laboratories, Nycomed Pharma AS, Norway
Active Comparator: hyperbaric levobupivacaine
hyperbaric levobupivacaine
Drug: hyperbaric levobupivacaine
0.42% hyperbaric levobupivacaine 3 ml spinal injection once
Other Name: Chirocaine, Abbott Laboratories, Nycomed Pharma AS, Norway



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01349751


Locations
Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Vimolluck - Sanansilp, MD Dept of Anesthesiology, Faculty of Medicine Siriraj Hospital

Responsible Party: Vimolluck Sanansilp, Associate Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01349751     History of Changes
Other Study ID Numbers: SiEC 197/2549
First Posted: May 9, 2011    Key Record Dates
Last Update Posted: November 7, 2013
Last Verified: November 2013

Keywords provided by Vimolluck Sanansilp, Mahidol University:
abdominal incision
hyperbaric
isobaric
levobupivacaine
spinal anaesthesia

Additional relevant MeSH terms:
Disease
Pathologic Processes
Levobupivacaine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents