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

December 2, 2009
March 30, 2013
January 2010
November 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01025102 on ClinicalTrials.gov Archive Site
Side effects [ Time Frame: On day of surgery and 1., 2. and. 3. postop. day ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Addition of Sufentanil Interscalene Block in Shoulder Surgery
Phase III Study of the Addition of Sufentanil to Interscalene Block in Shoulder Surgery

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Postoperative Pain
  • Shoulder Surgery
Drug: Naropin 0.1% cum sufentanil
20ml of Naropin 0.1% cum sufentanil 1mikrog per ml
Other Names:
  • Local analgetic
  • Ropivacain
Experimental: Naropin 0.1%
Intervention: Drug: Naropin 0.1% cum sufentanil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
December 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01025102
gymoese007
Yes
Bent Gymoese Jorgensen, Frederiksberg University Hospital
Bent Gymoese Jorgensen
Not Provided
Principal Investigator: Bent G Jørgensen, MD Anesthetic Clinic, Frederiksberg University Hospital
Frederiksberg University Hospital
March 2013

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