The Addition of Sufentanil Interscalene Block in Shoulder... | NCT01025102

Studies
The Addition of Sufentanil Interscalene Block in Shoulder Surgery

NCT01025102

Sponsor

Bent Gymoese Jorgensen

Status

Completed

Last Update Posted

Apr 2, 2013Estimated

Enrollment

26Actual

Phase

Phase 3

Conditions

Postoperative Pain
Shoulder Surgery

Interventions

Naropin 0.1% cum sufentanil

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

Mar 2013

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

Jan 2010

Primary Completion Date

Nov 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Dec 2, 2009

First Submission Date that Met QC Criteria

Dec 2, 2009

First Posted Date

Dec 3, 2009Estimated

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

Mar 30, 2013

Last Update Posted Date

Apr 2, 2013Estimated

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 this study is to compare the effects and side effects of interscale block performed with Naropin 0.1% cum sufentanil or Naropin 0.1% in shoulder surgery.

Detailed Description

The purpose of this study is to compare the duration of postoperative analgesia and supplemental opioid consumption and side effects of interscale block performed with Naropin 0.1% cum sufentanil or Naropin 0.1% in shoulder surgery

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Naropin 0.1%	Experimental		Drug: Naropin 0.1% cum sufentanil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Naropin 0.1% cum sufentanil	Drug	20ml of Naropin 0.1% cum sufentanil 1mikrog per ml	Naropin 0.1%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to experience of moderate to severe postoperative pain		On day of surgery and 1., 2. and 3. postop. day

Secondary Outcomes

Measure	Description	Time Frame
Side effects		On day of surgery and 1., 2. and. 3. postop. day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I-III
Age 18-80
Shoulder surgery performed under interscalene block and general anesthesia

Exclusion Criteria:

Contraindication of interscalene block
Severe chronic obstructive lung disease
Non-cooperative patient
Intolerance to opioids
Pregnancy
Rheumatoid arthritis and diabetes with peripheral polyneuropathy
Chronic pain or daily opioid intake

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

Name	Affiliation	Role
Bent G Jørgensen, MD	Anesthetic Clinic, Frederiksberg University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Anesthetic Clinic, Frederiksberg University Hospital		Frederiksberg	Frederiksberg	2000	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

Intervention Browse Module

MeSH Terms

ID	Term
D000077212	Ropivacaine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided