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

Spinal Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01245868
• Other study ID #: FRS-AN2009-03-09
• Status: Completed
• Phase: Phase 4
• First received: June 14, 2010
• Last updated: May 7, 2015
• Start date: November 2009
• Est. completion date: December 2010

Study information

• Verified date: May 2015
• Source: Frederikssunds Hospital, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Anesthesia

Intervention

Drug:
• Lidocaine

• bupivacaine

Locations

Country	Name	City	State
Denmark	Dep. of anesthesiology, Hospital of Frederikssund	Frederikssund
Denmark	Jon Jacobsen	Frederikssund

Sponsors (1)

Lead Sponsor	Collaborator
Frederikssunds Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of spinal blockade		Repeating monitoring every 15 minutes after applying the blockade, up to 360 minutes.	No
Secondary	Time to fulfillment of discharge criteria from the hospital.		Evaluated every 15 minutes after the operation up to 360 minutes. On average 200 to 300 minutes.	No