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The Addition of Sufentanil Interscalene Block in Shoulder Surgery

Sponsor
Bent Gymoese Jorgensen (Other)
Overall Status
Completed
CT.gov ID
NCT01025102
Collaborator
(none)
26
Enrollment
1
Location
1
Arm
35
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Naropin 0.1% cum sufentanil
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
26 participants
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
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Nov 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to experience of moderate to severe postoperative pain [On day of surgery and 1., 2. and 3. postop. day]

    Secondary Outcome Measures

    1. Side effects [On day of surgery and 1., 2. and. 3. postop. day]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bent Gymoese Jorgensen, MD, Frederiksberg University Hospital
    ClinicalTrials.gov Identifier:
    NCT01025102
    Other Study ID Numbers:
    • gymoese007
    First Posted:
    Dec 3, 2009
    Last Update Posted:
    Apr 2, 2013
    Last Verified:
    Mar 1, 2013
    Additional relevant MeSH terms:
    Pain, Postoperative
    Sufentanil
    Ropivacaine

    Study Results

    No Results Posted as of Apr 2, 2013