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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Anne Holmberg, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01740141
First received: November 22, 2012
Last updated: April 21, 2015
Last verified: April 2015
  Purpose

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 Intervention
Pain
Procedure: Plexus brachialis block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Plexus Brachialis Block. Better to do by Start Than by End of Surgery?

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Pain [ Time Frame: postoperative to 6 months ] [ Designated as safety issue: No ]
    NAS


Estimated Enrollment: 50
Study Start Date: November 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Anne Holmberg, Principal investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01740141     History of Changes
Other Study ID Numbers: 2011/476a
Study First Received: November 22, 2012
Last Updated: April 21, 2015
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Oslo University Hospital:
Pain

ClinicalTrials.gov processed this record on April 30, 2015