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

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ClinicalTrials.gov Identifier: NCT01740141
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
Anne Holmberg, Oslo University Hospital

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 Phase
Pain Procedure: Plexus brachialis block Not Applicable

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
Actual Primary Completion Date : June 2015
Actual Study Completion Date : April 2016

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




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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

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

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