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Spinal Anaesthesia for Knee Arthroscopy: Does Lignocaine Shorten the Effect of Bupivacaine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01245868
First Posted: November 23, 2010
Last Update Posted: May 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jon Jacobsen, Frederikssunds Hospital, Denmark
  Purpose
The purpose of the study is to investigate if a small amount of lignocaine added to bupivacaine for spinal anesthesia to patients planned for arthroscopic knee surgery, can shorten the duration of the sensoric and the motoric blockade.

Condition Intervention Phase
Spinal Anesthesia Drug: Lidocaine Drug: bupivacaine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Spinal Anaesthesia for Knee Arthroscopy: Does Lignocaine Shorten the Effect of Bupivacaine?

Resource links provided by NLM:


Further study details as provided by Jon Jacobsen, Frederikssunds Hospital, Denmark:

Primary Outcome Measures:
  • Duration of spinal blockade [ Time Frame: Repeating monitoring every 15 minutes after applying the blockade, up to 360 minutes. ]

Secondary Outcome Measures:
  • Time to fulfillment of discharge criteria from the hospital. [ Time Frame: Evaluated every 15 minutes after the operation up to 360 minutes. On average 200 to 300 minutes. ]

Enrollment: 60
Study Start Date: November 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bupivacaine
Bupivacaine as used routinely
Drug: bupivacaine
Placebo Comparator: Lidocaine added to bupivacaine
lidocaine is added to bupivacaine
Drug: Lidocaine Drug: bupivacaine

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient want spinal anaesthesia
  • No contradictions against spinal anaesthesia
  • Healthy people (ASA-score 1 or 2)
  • Body mass index < 35 and between 155 and 190 cm

Exclusion Criteria:

  • Known allergic reactions to planned drugs
  • Neurologic disturbances
  • Diabetes
  Contacts and Locations
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): NCT01245868


Locations
Denmark
Dep. of anesthesiology, Hospital of Frederikssund
Frederikssund, Denmark, 3600
Jon Jacobsen
Frederikssund, Denmark, DK 3600
Sponsors and Collaborators
Frederikssunds Hospital, Denmark
Investigators
Principal Investigator: Jon Jacobsen, M.D. Frederikssunds Hospital, Denmark
  More Information

Responsible Party: Jon Jacobsen, Chief consultant, Frederikssunds Hospital, Denmark
ClinicalTrials.gov Identifier: NCT01245868     History of Changes
Other Study ID Numbers: FRS-AN2009-03-09
First Submitted: June 14, 2010
First Posted: November 23, 2010
Last Update Posted: May 8, 2015
Last Verified: May 2015

Keywords provided by Jon Jacobsen, Frederikssunds Hospital, Denmark:
Spinal anaesthesia
Bupivacaine
Lidocaine
Duration of blockade

Additional relevant MeSH terms:
Anesthetics
Lidocaine
Bupivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action