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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01740141
Other study ID # 2011/476a
Secondary ID
Status Completed
Phase N/A
First received November 22, 2012
Last updated April 5, 2016
Start date November 2012
Est. completion date April 2016

Study information

Verified date April 2016
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: Regional Ethics Commitee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date April 2016
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Plexus brachialis block


Locations

Country Name City State
Norway Oslo Universitetssykehus, Ullevaal, dept of anaesthesiology, legevakten Oslo

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain NAS postoperative to 6 months No
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