Spinal Anaesthesia for Knee Arthroscopy: Does Lignocaine... | NCT01245868

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

NCT01245868

Sponsor

Frederikssunds Hospital, Denmark

Status

Completed

Last Update Posted

May 8, 2015Estimated

Enrollment

60Actual

Phase

Phase 4

Conditions

Spinal Anesthesia

Interventions

Lidocaine
bupivacaine

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Jun 14, 2010

First Submission Date that Met QC Criteria

Nov 22, 2010

First Posted Date

Nov 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2015

Last Update Posted Date

May 8, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jon Jacobsen, Chief consultant, Frederikssunds Hospital, DenmarkPrincipal Investigator

Lead Sponsor

Frederikssunds Hospital, DenmarkOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bupivacaine	Experimental	Bupivacaine as used routinely	Drug: bupivacaine
Lidocaine added to bupivacaine	Placebo Comparator	lidocaine is added to bupivacaine	Drug: Lidocaine Drug: bupivacaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lidocaine	Drug		Lidocaine added to bupivacaine
bupivacaine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jon Jacobsen, M.D.	Frederikssunds Hospital, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dep. of anesthesiology, Hospital of Frederikssund		Frederikssund		3600	Denmark
Jon Jacobsen

Intervention Browse Module

MeSH Terms

ID	Term
D008012	Lidocaine
D002045	Bupivacaine

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided