NCT01025102

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_3 postoperative-pain

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_3 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
29 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 2, 2013

Status Verified

March 1, 2013

Enrollment Period

2.8 years

First QC Date

December 2, 2009

Last Update Submit

March 30, 2013

Conditions

Postoperative PainShoulder Surgery

Outcome Measures

Primary Outcomes (1)

  • Time to experience of moderate to severe postoperative pain

    On day of surgery and 1., 2. and 3. postop. day

Secondary Outcomes (1)

  • Side effects

    On day of surgery and 1., 2. and. 3. postop. day

Study Arms (1)

Naropin 0.1%

EXPERIMENTAL
Drug: Naropin 0.1% cum sufentanil

Interventions

Naropin 0.1% cum sufentanilDRUG

20ml of Naropin 0.1% cum sufentanil 1mikrog per ml

Also known as: Local analgetic, Ropivacain
Naropin 0.1%

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III
  • Age 18-80
  • Shoulder surgery performed under interscalene block and general anesthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthetic Clinic, Frederiksberg University Hospital

Frederiksberg, Frederiksberg, 2000, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Bent G Jørgensen, MD

    Anesthetic Clinic, Frederiksberg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 3, 2009

Study Start

January 1, 2010

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

April 2, 2013

Record last verified: 2013-03

Locations

DK(1)