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

May 7, 2015 updated by: Jon Jacobsen, Frederikssunds Hospital, Denmark

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederikssund, Denmark, 3600
        • Dep. of anesthesiology, Hospital of Frederikssund
      • Frederikssund, Denmark, DK 3600
        • Jon Jacobsen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bupivacaine
Bupivacaine as used routinely
Drug: bupivacaine
Placebo Comparator: Lidocaine added to bupivacaine
lidocaine is added to bupivacaine
Drug: Lidocaine
Drug: bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of spinal blockade
Time Frame: Repeating monitoring every 15 minutes after applying the blockade, up to 360 minutes.
Repeating monitoring every 15 minutes after applying the blockade, up to 360 minutes.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Evaluated every 15 minutes after the operation up to 360 minutes. On average 200 to 300 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Frederikssunds Hospital, Denmark

Investigators

  • Principal Investigator: Jon Jacobsen, M.D., Frederikssunds Hospital, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

June 14, 2010

First Submitted That Met QC Criteria

November 22, 2010

First Posted (Estimate)

November 23, 2010

Study Record Updates

Last Update Posted (Estimate)

May 8, 2015

Last Update Submitted That Met QC Criteria

May 7, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRS-AN2009-03-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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