NCT01740141

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

2.6 years

First QC Date

November 22, 2012

Last Update Submit

April 5, 2016

Conditions

Pain

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

  • Pain

    NAS

    postoperative to 6 months

Study Arms (2)

Plexus before surgery

OTHER

Plexus brachialis before surgery

Procedure: Plexus brachialis block

Plexus after surgery

OTHER

Plexus brachialis performed after surgery

Procedure: Plexus brachialis block

Interventions

Plexus brachialis blockPROCEDURE
Also known as: LSIB. Ropivacain 7,5 mg/ml, 0,5 ml/kg
Plexus after surgeryPlexus before surgery

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Chronic pain
  • BMI over 35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo Universitetssykehus, Ullevaal, dept of anaesthesiology, legevakten

Oslo, Oslo County, 0540, Norway

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anne Holmberg, MD

    MD Ullevaal sykehus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 22, 2012

First Posted

December 4, 2012

Study Start

November 1, 2012

Primary Completion

June 1, 2015

Study Completion

April 1, 2016

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations

NO(1)