The Addition of Sufentanil Interscalene Block in Shoulder Surgery

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bent Gymoese Jorgensen, Frederiksberg University Hospital

ClinicalTrials.gov Identifier:

NCT01025102

First received: December 2, 2009

Last updated: March 30, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 2, 2009

Last Updated Date

March 30, 2013

Start Date ^ICMJE

January 2010

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time to experience of moderate to severe postoperative pain [ Time Frame: On day of surgery and 1., 2. and 3. postop. day ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01025102 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Side effects [ Time Frame: On day of surgery and 1., 2. and. 3. postop. day ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Addition of Sufentanil Interscalene Block in Shoulder Surgery

Official Title ^ICMJE

Phase III Study of the Addition of Sufentanil to Interscalene Block in Shoulder Surgery

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care

Condition ^ICMJE

Postoperative Pain
Shoulder Surgery

Intervention ^ICMJE

Drug: Naropin 0.1% cum sufentanil

20ml of Naropin 0.1% cum sufentanil 1mikrog per ml

Other Names:

Local analgetic
Ropivacain

Study Arm (s)

Experimental: Naropin 0.1%

Intervention: Drug: Naropin 0.1% cum sufentanil

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2012

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01025102

Other Study ID Numbers ^ICMJE

gymoese007

Has Data Monitoring Committee

Yes

Responsible Party

Bent Gymoese Jorgensen, Frederiksberg University Hospital

Study Sponsor ^ICMJE

Bent Gymoese Jorgensen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Bent G Jørgensen, MD

Anesthetic Clinic, Frederiksberg University Hospital

Information Provided By

Frederiksberg University Hospital

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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