NCT02630498

Brief Summary

This is a non-randomized prospective study. Patients undergoing upper extremity and shoulder surgical procedures after trauma at SJHC and LHSC will be divided in to two groups. The first group will include those who receive a single shot brachial plexus (interscalene, supraclavicular, infraclavicular and axillary) block with or without general anesthesia. The second group will be the control group and include those patients who receive general anesthesia only, without any block whether due to the preference of patient or the surgeon

Trial Health

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Monitor

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 15, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

2.5 years

First QC Date

August 11, 2015

Last Update Submit

September 23, 2022

Conditions

Keywords

painsurgicalbrachial plexus

Outcome Measures

Primary Outcomes (1)

  • Chronic Post Surgical Pain

    Upto six months

Study Arms (2)

study (first group)

EXPERIMENTAL

The first group will include those who receive a single shot brachial plexus block with or without general anesthesia.

Procedure: Brachial plexus block

Controlled (second group)

NO INTERVENTION

The second group will be the control group and include those patients who receive general anesthesia only, without any block whether due to the preference of patient or the surgeon.

Interventions

Patients receiving brachial plexus block for hand/arm surgery

study (first group)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Trauma patient undergoing orthopedic surgery for upper extremity or shoulder
  • Age \>18 and \< 75 years
  • Both males and females
  • Understand English (reading, writing and speaking)
  • Patient gives a written consent for being involved in this study

You may not qualify if:

  • Patient with any sort of chronic pain including fibromyalgia
  • Patient using opioids for \>90 days
  • Patient who had an associated injury related to the trauma apart from that limb
  • Patient who need more than one surgery to fix the problem
  • Patient diagnosed with major depression
  • Failed or partially effective block
  • Bilateral surgical intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Joseph's Hospital

London, Ontario, N6A 4V2, Canada

Location

LHSC, SJHC, Western University

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Chronic PainPain

Interventions

Brachial Plexus Block

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nerve BlockAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Shalini Dhir, FRCPC

    LHSC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
AssociateProfessor

Study Record Dates

First Submitted

August 11, 2015

First Posted

December 15, 2015

Study Start

August 1, 2015

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

September 27, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations