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

April 5, 2016 updated by: Anne Holmberg, Oslo University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

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

  • Norway
      • Oslo, Norway, 0540
        • Oslo Universitetssykehus, Ullevaal, dept of anaesthesiology, legevakten

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Plexus before surgery
Plexus brachialis before surgery
Procedure: Plexus brachialis block
Other Names:
  • LSIB. Ropivacain 7,5 mg/ml, 0,5 ml/kg
Other: Plexus after surgery
Plexus brachialis performed after surgery
Procedure: Plexus brachialis block
Other Names:
  • LSIB. Ropivacain 7,5 mg/ml, 0,5 ml/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: postoperative to 6 months
NAS
postoperative to 6 months

Collaborators and Investigators

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

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Anne Holmberg, MD, MD Ullevaal sykehus

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

November 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

November 22, 2012

First Submitted That Met QC Criteria

November 29, 2012

First Posted (Estimate)

December 4, 2012

Study Record Updates

Last Update Posted (Estimate)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2011/476a

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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