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The Addition of Sufentanil Interscalene Block in Shoulder Surgery

Primary Purpose

Postoperative Pain, Shoulder Surgery

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Naropin 0.1% cum sufentanil
Sponsored by
Bent Gymoese Jorgensen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Anesthetic Clinic, Frederiksberg University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Naropin 0.1%

Arm Description

Outcomes

Primary Outcome Measures

Time to experience of moderate to severe postoperative pain

Secondary Outcome Measures

Side effects

Full Information

First Posted
December 2, 2009
Last Updated
March 30, 2013
Sponsor
Bent Gymoese Jorgensen
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1. Study Identification

Unique Protocol Identification Number
NCT01025102
Brief Title
The Addition of Sufentanil Interscalene Block in Shoulder Surgery
Official Title
Phase III Study of the Addition of Sufentanil to Interscalene Block in Shoulder Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bent Gymoese Jorgensen

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Shoulder Surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naropin 0.1%
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Naropin 0.1% cum sufentanil
Other Intervention Name(s)
Local analgetic, Ropivacain
Intervention Description
20ml of Naropin 0.1% cum sufentanil 1mikrog per ml
Primary Outcome Measure Information:
Title
Time to experience of moderate to severe postoperative pain
Time Frame
On day of surgery and 1., 2. and 3. postop. day
Secondary Outcome Measure Information:
Title
Side effects
Time Frame
On day of surgery and 1., 2. and. 3. postop. day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bent G Jørgensen, MD
Organizational Affiliation
Anesthetic Clinic, Frederiksberg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anesthetic Clinic, Frederiksberg University Hospital
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark

12. IPD Sharing Statement

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The Addition of Sufentanil Interscalene Block in Shoulder Surgery

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