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Plexus Brachialis Block. Better to do by Start Than by End of Surgery?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01740141
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The aim of the study is to find out if the timing of brachial plexus block, before or after surgery, has an impact of the extent of acute postoperative surgical pain or the incidence and severity of long-lasting (chronic) pain after surgery.

This is a prospective, randomized, double blind study in patients with radial fractures undergoing surgery with volar plate. The patients will be followed up for 6 months after surgery.


Condition or disease Intervention/treatment
Pain Procedure: Plexus brachialis block

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Plexus Brachialis Block. Better to do by Start Than by End of Surgery?
Study Start Date : November 2012
Primary Completion Date : June 2015
Study Completion Date : April 2016
Arms and Interventions

Arm Intervention/treatment
Plexus before surgery
Plexus brachialis before surgery
Procedure: Plexus brachialis block
Other Name: LSIB. Ropivacain 7,5 mg/ml, 0,5 ml/kg
Plexus after surgery
Plexus brachialis performed after surgery
Procedure: Plexus brachialis block
Other Name: LSIB. Ropivacain 7,5 mg/ml, 0,5 ml/kg


Outcome Measures

Primary Outcome Measures :
  1. Pain [ Time Frame: postoperative to 6 months ]
    NAS


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Radial fracture
  • ASA 1 and 2
  • Able to communicate in norwegian
  • Suitable for surgery in general anaesthesia and brachial plexus block

Exclusion Criteria:

  • Pregnancy
  • Chronic pain
  • BMI over 35
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740141


Locations
Norway
Oslo Universitetssykehus, Ullevaal, dept of anaesthesiology, legevakten
Oslo, Norway, 0540
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Anne Holmberg, MD MD Ullevaal sykehus
More Information

Responsible Party: Anne Holmberg, Principal investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01740141     History of Changes
Other Study ID Numbers: 2011/476a
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016

Keywords provided by Anne Holmberg, Oslo University Hospital:
Pain