NCT02486549

Brief Summary

The purpose of this study is to compare the supraclavicular block to interscalene block in patients undergoing arthroscopic shoulder surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Jun 2015

Typical duration 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

June 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1.7 years

First QC Date

June 24, 2015

Last Update Submit

February 20, 2017

Conditions

Pain

Keywords

PainAnesthesia Recovery PeriodBrachial Plexus

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain

    The visual analog scale will be used for assessment

    up to postoperative 24 hours

Secondary Outcomes (7)

  • Quality of recovery

    in the postoperative 24 hours

  • Motor block

    up to postoperative 24 hours

  • Sensory block

    up to postoperative 24 hours

  • Adverse events

    up to postoperative 24 hours

  • Analgesics requirement time

    up to postoperative 24 hours

  • +2 more secondary outcomes

Study Arms (2)

Supraclavicular Block

EXPERIMENTAL

Ultrasound guided supraclavicular block with 20 ml of 0.25% bupivacaine will be performed

Procedure: Supraclavicular BlockDrug: BupivacaineDevice: Ultrasound

Interscalene block

ACTIVE COMPARATOR

Ultrasound guided inter scalene block with 20ml of 0.25% bupivacaine will be performed.

Procedure: Interscalene BlockDrug: BupivacaineDevice: Ultrasound

Interventions

Supraclavicular BlockPROCEDURE

Under ultrasound guidance an insulated needle is advanced with in- plane technique into the brachial plexus sheath and 20ml 0.25% bupivacaine will be administered

Supraclavicular Block
Interscalene BlockPROCEDURE

Under ultrasound guidance an insulated needle will be placed through the middle scalene muscle,into the interscalene groove with in-plane technique and 20ml 0.25%bupivacaine will be administered into the brachial plexus

Interscalene block
BupivacaineDRUG

20ml 0.25% bupivacaine will be injected for brachial plexus block

Also known as: Marcaine
Interscalene blockSupraclavicular Block
UltrasoundDEVICE

The Ultrasound will be used for brachial plexus visualization

Interscalene blockSupraclavicular Block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing shoulder surgery in American Society of Anesthesiologists physical status I-II

You may not qualify if:

  • with a known allergy to study medications,
  • chronic opioid use,
  • ipsilateral upper limb neurological deficits,
  • severe respiratory disease,
  • coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa University Medical School

Tokat Province, 60100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

BupivacaineUltrasonography

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Tugba Karamanaraman, M.D.

    Gaziosmanpasa University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, M.D.

Study Record Dates

First Submitted

June 24, 2015

First Posted

July 1, 2015

Study Start

June 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

TU(1)