Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Frederikssunds Hospital, Denmark
ClinicalTrials.gov Identifier:
NCT01245868
First received: June 14, 2010
Last updated: December 20, 2010
Last verified: September 2009
History of Changes
  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 added to bupivacaine for spinal anaesthesia
 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:

U.S. FDA Resources

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 ]

Estimated 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
No Intervention: Bupivacaine
Bupivacaine as used routinely
 Drug: Lidocaine added to bupivacaine for spinal anaesthesia
Bupivacaine 0.5% 2 ml(Marcain Spinal) is used for spinal anaesthesia. In half of the patients lidocaine 1% 0.6 ml is added to bupivacaine.
No Intervention: Lidocaine added to bupivacaine
lidocaine is added to 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
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, Dept. of Anaesthesiology, Frederikssund 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: December 20, 2010
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
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
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013