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A Randomised Comparison on the Dose Requirement Between, Levobupivacaine, Ropivacaine and Bupivacaine in Intrathecal Anaesthesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00636974
First received: December 19, 2007
Last updated: July 6, 2010
Last verified: July 2010
History of Changes
  Purpose

To determine and compare the effective intrathecal dose of levobupivacaine, ropivacaine and bupivacaine for 50% of patients in lower limb surgery


Condition Intervention
Anesthesia, Conduction
Surgery
 Procedure: Combined spinal epidural anaesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Minimum Local Anaesthetic Dose for Intrathecal Anaesthesia: a Randomised Comparison Between Levobupivacaine, Ropivacaine and Bupivacaine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:
  • Sensory block at 12th thoracic dermatome or above and successful conduct of the lower limb surgery up to 50 minutes after the intrathecal injection of the study drug [ Time Frame: 50 minutes after the intrathecal injection of the study drug ]

Estimated Enrollment: 75
Study Start Date: January 2006
Estimated Study Completion Date: July 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • body weight=40-90kg,
  • height higher than 145cm

Exclusion Criteria:

  • Known hypersensitivity to amide local anaesthetics,
  • patients who do not understand English and Chinese,
  • Body mass index higher than 35 kg per sq metre
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636974

Contacts
Contact: Ying Yin Lee, Dr (852) 3517 5056 yylee@ha.org.hk

Locations
China
Kwong Wah Hospital Recruiting
Hong Kong, China
Sub-Investigator: Warwick Ngan Kee, Prof            
Sub-Investigator: John Liu, Dr            
Sub-Investigator: Yan Fong Siu, Dr            
Sub-Investigator: Tony Gin, Prof            
Sponsors and Collaborators
Hospital Authority, Hong Kong
Investigators
Principal Investigator: Ying Yin Lee, Dr Department of Anaesthesiology, Kwong Wah Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00636974     History of Changes
Other Study ID Numbers: KW/FR/05-025, HARECCTR0500056
Study First Received: December 19, 2007
Last Updated: July 6, 2010
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:
Patients who are going to have regional anaesthesia for lower limbs surgery.
Leg Surgery.

Additional relevant MeSH terms:
Anesthetics
Bupivacaine
Ropivacaine
Levobupivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013