NCT02182752

Brief Summary

The purpose of our study is to evaluate the effect of tramadol as an adjunct to ropivacaine local anesthetic solution in interscalene brachial plexus block for shoulder surgery.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

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

April 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

2.8 years

First QC Date

June 30, 2014

Last Update Submit

January 2, 2016

Conditions

Shoulder FractureShoulder DislocationRotator Cuff InjuryShoulder Arthritis

Outcome Measures

Primary Outcomes (1)

  • Postoperative analgesia

    24 hours postoperatively

Secondary Outcomes (3)

  • Persistent postoperative pain

    1 month postoperatively, 3 months postoperatively

  • Evidence of motor blockade resolution, confirmed by elbow - wrist - fingers active movement

    24 hours postoperatively

  • Evidence of sensory blockade resolution, confirmed by pin-prick test

    24 hours postoperatively

Study Arms (2)

Ropivacaine - Tramadol

ACTIVE COMPARATOR
Drug: Ropivacaine - Tramadol

Ropivacaine

ACTIVE COMPARATOR
Drug: Ropivacaine

Interventions

Ropivacaine - TramadolDRUG

Interscalene block using ropivacaine plus tramadol

Ropivacaine - Tramadol
RopivacaineDRUG

Interscalene block using ropivacaine

Ropivacaine

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Shoulder surgery

You may not qualify if:

  • patients on opioids
  • diabetes mellitus
  • interscalene block contraindicated
  • patient refusing regional anesthesia techniques

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asklepieion Hospital of Voula

Athens, Attica, 16673, Greece

Location

Related Publications (2)

  • Lin E, Choi J, Hadzic A. Peripheral nerve blocks for outpatient surgery: evidence-based indications. Curr Opin Anaesthesiol. 2013 Aug;26(4):467-74. doi: 10.1097/ACO.0b013e328362baa4.

    PMID: 23820103BACKGROUND

  • Bishop JY, Sprague M, Gelber J, Krol M, Rosenblatt MA, Gladstone JN, Flatow EL. Interscalene regional anesthesia for arthroscopic shoulder surgery: a safe and effective technique. J Shoulder Elbow Surg. 2006 Sep-Oct;15(5):567-70. doi: 10.1016/j.jse.2006.01.009.

    PMID: 16979050BACKGROUND

MeSH Terms

Conditions

Shoulder FracturesShoulder DislocationRotator Cuff Injuries

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder InjuriesJoint DislocationsJoint DiseasesMusculoskeletal DiseasesRuptureTendon Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 30, 2014

First Posted

July 8, 2014

Study Start

April 1, 2013

Primary Completion

January 1, 2016

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations

GR(1)