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The Addition of Sufentanil Interscalene Block in Shoulder Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01025102
First Posted: December 3, 2009
Last Update Posted: April 2, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bent Gymoese Jorgensen, Frederiksberg University Hospital
  Purpose
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.

Condition Intervention Phase
Postoperative Pain Shoulder Surgery Drug: Naropin 0.1% cum sufentanil Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Phase III Study of the Addition of Sufentanil to Interscalene Block in Shoulder Surgery

Resource links provided by NLM:


Further study details as provided by Bent Gymoese Jorgensen, Frederiksberg University Hospital:

Primary Outcome Measures:
  • Time to experience of moderate to severe postoperative pain [ Time Frame: On day of surgery and 1., 2. and 3. postop. day ]

Secondary Outcome Measures:
  • Side effects [ Time Frame: On day of surgery and 1., 2. and. 3. postop. day ]

Enrollment: 26
Study Start Date: January 2010
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Naropin 0.1% Drug: Naropin 0.1% cum sufentanil
20ml of Naropin 0.1% cum sufentanil 1mikrog per ml
Other Names:
  • Local analgetic
  • Ropivacain

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01025102


Locations
Denmark
Anesthetic Clinic, Frederiksberg University Hospital
Frederiksberg, Denmark, 2000
Sponsors and Collaborators
Bent Gymoese Jorgensen
Investigators
Principal Investigator: Bent G Jørgensen, MD Anesthetic Clinic, Frederiksberg University Hospital
  More Information

Responsible Party: Bent Gymoese Jorgensen, MD, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT01025102     History of Changes
Other Study ID Numbers: gymoese007
First Submitted: December 2, 2009
First Posted: December 3, 2009
Last Update Posted: April 2, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Sufentanil
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Local