Clinical Characteristics of Spinal Levobupivacaine: Hyperbaric Compared With Isobaric Solution

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vimolluck Sanansilp, Mahidol University
ClinicalTrials.gov Identifier:
NCT01349751
First received: May 5, 2011
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Clinical Characteristics of Spinal Levobupivacaine: Hyperbaric Compared With Isobaric Solution

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • time to T4-dermatome sensory blockade [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    to investigate specific blocking characteristics of intrathecal hyperbaric levobupivacaine compared with isobaric levobupivacaine for gynaecologic surgery


Secondary Outcome Measures:
  • side effects [ Time Frame: 1 to 4 hours intraoperation plus within 2 hours in the recovery room ] [ Designated as safety issue: Yes ]
    to investigate side effects of intrathecal hyperbaric levobupivacaine compared with isobaric levobupivacaine for gynaecologic surgery


Enrollment: 20
Study Start Date: January 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Vimolluck Sanansilp, Associate Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01349751     History of Changes
Other Study ID Numbers: SiEC 197/2549
Study First Received: May 5, 2011
Last Updated: November 5, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by 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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014