Local Infiltration Analgesia in Major Spine Surgery With... | NCT00771459

Studies
Local Infiltration Analgesia in Major Spine Surgery With Ropivacaine Versus Placebo

NCT00771459

Sponsor

Hvidovre University Hospital

Status

Completed

Last Update Posted

Jun 23, 2011Estimated

Enrollment

48Estimated

Phase

Phase 4

Conditions

Pain, Postoperative

Interventions

Ropivacaine 0.5 %
Isotonic NaCl

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

Oct 2008

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

Oct 2008

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Oct 10, 2008

First Submission Date that Met QC Criteria

Oct 10, 2008

First Posted Date

Oct 13, 2008Estimated

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

Jun 22, 2011

Last Update Posted Date

Jun 23, 2011Estimated

Description Module

Brief Summary

The purpose of this study is to examine whether local infiltration analgesia (LIA) with Ropivacaine and adrenaline is effective in the treatment of postoperative pain after major spine surgery.

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

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ropivacaine	Active Comparator		Drug: Ropivacaine 0.5 %
Placebo	Placebo Comparator		Drug: Isotonic NaCl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ropivacaine 0.5 %	Drug	Local infiltration analgesia	Ropivacaine
Isotonic NaCl

Measure	Description	Time Frame
Postoperative Pain		0-48 h postoperatively

Measure	Description	Time Frame
Analgesia consumption		0-48 h postoperatively

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients eligible for major spine surgery
must speak and understand Danish
must be able to give oral and written consent

Exclusion Criteria:

alcohol or medicine abuse
treatment with opioids > 100 mg daily
allergy to local anesthetics
severe obesity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre University Hospital		Copenhagen	Hvidovre	2650	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided