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

This study has been completed.
Sponsor:
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00636974
First received: December 19, 2007
Last updated: October 22, 2013
Last verified: October 2013
  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:


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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636974

Locations
China
Kwong Wah Hospital
Hong Kong, China
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: October 22, 2013
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 July 22, 2014