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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
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Bent Gymoese Jorgensen, MD, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT01025102     History of Changes
Other Study ID Numbers: gymoese007
Study First Received: December 2, 2009
Last Updated: March 30, 2013
Health Authority: Denmark: National Board of Health

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

ClinicalTrials.gov processed this record on May 16, 2013