The Addition of Sufentanil Interscalene Block in Shoulder Surgery

March 30, 2013 updated by: Bent Gymoese Jorgensen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

26

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg, Denmark, 2000
        • Anesthetic Clinic, Frederiksberg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to experience of moderate to severe postoperative pain
Time Frame: On day of surgery and 1., 2. and 3. postop. day
On day of surgery and 1., 2. and 3. postop. day

Secondary Outcome Measures

Outcome Measure
Time Frame
Side effects
Time Frame: On day of surgery and 1., 2. and. 3. postop. day
On day of surgery and 1., 2. and. 3. postop. day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bent Gymoese Jorgensen

Investigators

  • Principal Investigator: Bent G Jørgensen, MD, Anesthetic Clinic, Frederiksberg University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

December 2, 2009

First Submitted That Met QC Criteria

December 2, 2009

First Posted (ESTIMATE)

December 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 2, 2013

Last Update Submitted That Met QC Criteria

March 30, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • gymoese007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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