NCT02495688

Brief Summary

The purpose of this study is to compare general and regional anesthesia with regard to postoperative pain in patients who undergo surgery in a day surgery setting due to a displaced distal radius fracture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

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

March 23, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 13, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2017

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

1.6 years

First QC Date

July 8, 2015

Last Update Submit

January 21, 2018

Conditions

Distal Radius FracturePostoperative Pain

Keywords

General AnesthesiaRegional Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative opioid consumption

    The total amount of administered and consumed opioids is calculated for the first 72 hours postoperatively.

    72 hours after day care surgery

Secondary Outcomes (6)

  • Pain

    14 days

  • Postoperative Nausea and Vomiting (PONV)

    24 hours

  • PRWE

    6 months

  • EQ5D

    6 months

  • ROM

    6 months

  • +1 more secondary outcomes

Other Outcomes (1)

  • Resource utilisation

    24 hours

Study Arms (2)

Regional anesthesia

EXPERIMENTAL

Patients are anesthezised with local aneshtetics administered with ultrasound guidance in the nerval plexus of the arm.

Procedure: Regional anesthesia

General anesthesia

ACTIVE COMPARATOR

Patients are anesthezised with general anesthesia and orotrachial airway. Local anesthetics (Chirocaine 5 mg/ml, 10 ml) is administered in the surgical wound during surgery.

Procedure: General anesthesia

Interventions

Regional anesthesiaPROCEDURE

Standard supraclavicular brachial plexus nerve block. Ultrasound-assisted. By an anesthesiologist. A mix of short- and medium lasting local anesthetics will be used.

Regional anesthesia
General anesthesiaPROCEDURE

Standard procedure.

General anesthesia

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-74 years planned for surgery with a volar plate due to displaced distal radius fracture.

You may not qualify if:

  • Dementia,
  • alcohol abuse,
  • medical condition that interferes with either allocation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Södersjukhuset, Stockholm Soder Hospital

Stockholm, 11883, Sweden

Location

Related Publications (1)

  • Egol KA, Soojian MG, Walsh M, Katz J, Rosenberg AD, Paksima N. Regional anesthesia improves outcome after distal radius fracture fixation over general anesthesia. J Orthop Trauma. 2012 Sep;26(9):545-9. doi: 10.1097/BOT.0b013e318238becb.

    PMID: 22377510BACKGROUND

MeSH Terms

Conditions

Wrist FracturesPain, Postoperative

Interventions

Anesthesia, ConductionAnesthesia, General

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, BonePostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Anders Enocson, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, PhD

Study Record Dates

First Submitted

July 8, 2015

First Posted

July 13, 2015

Study Start

March 23, 2015

Primary Completion

November 12, 2016

Study Completion

May 16, 2017

Last Updated

January 23, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)