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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jon Jacobsen, Frederikssunds Hospital, Denmark
ClinicalTrials.gov Identifier:
NCT01245868
First received: June 14, 2010
Last updated: May 7, 2015
Last verified: May 2015
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Jon Jacobsen, Chief consultant, Frederikssunds Hospital, Denmark
ClinicalTrials.gov Identifier: NCT01245868     History of Changes
Other Study ID Numbers: FRS-AN2009-03-09
Study First Received: June 14, 2010
Last Updated: May 7, 2015
Health Authority: Denmark: Danish Medicines Agency

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

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

ClinicalTrials.gov processed this record on July 01, 2015