Local Anaesthesia Used During Fast-track Colonic Surgery:... | NCT01105442

Studies
Local Anaesthesia Used During Fast-track Colonic Surgery: Evaluation of Bupivacaine and Levobupivacaine in Practice

NCT01105442

Sponsor

Martini Hospital Groningen

Status

Completed

Last Update Posted

Jul 21, 2011Estimated

Enrollment

14Actual

Phase

Not provided

Conditions

Colonic Diseases
Post-operative Pain
Local Anesthesia

Interventions

Not provided

Countries

Netherlands

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

Mar 2010

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

Apr 2010

Primary Completion Date

Jun 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Apr 15, 2010

First Submission Date that Met QC Criteria

Apr 15, 2010

First Posted Date

Apr 16, 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

Jul 20, 2011

Last Update Posted Date

Jul 21, 2011Estimated

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 standard treatment for post operative pain is now bupivacaine + sufentanil. The use of this combination during fast-track colonic surgery leads frequently to post-operative nausea and vomiting and limited mobilisation possibilities. Therefore the department anaesthesiology wants to evaluate the use of a different local anaesthetic: levobupivacaine combined with morphine on demand. The expectation is that the use of levobupivacaine leads to less side effects.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bupivacaine		Patients who received bupivacaine + sufentanil
Levobupivacaine		Patients who received levobupivacaine and morphine on demand

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who undergo fast-track colonic surgery and with post operative epidural pain treatment

Exclusion Criteria:

Patients who are admitted to an other ward
Patients with a spinal catheter

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Martini Hospital Groningen

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marinus van Hulst, Dr.	Martini Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Martini Hospital ward 4b		Groningen	Provincie Groningen	9700 RM	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D003108	Colonic Diseases
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided