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CompletedNCT02182752Updated Jan 5, 2016

The Effect of Tramadol on Interscalene Brachial Plexus Block

A Phase 2 interventional study of Ropivacaine - Tramadol and Ropivacaine in Shoulder Fracture, Shoulder Dislocation and Rotator Cuff Injury, sponsored by Asklepieion Voulas General Hospital. Completed at 1 site in Greece. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2016-01-05.

Sponsored by Asklepieion Voulas General Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Shoulder Fracture
  • Shoulder Dislocation
  • Rotator Cuff Injury
  • Shoulder Arthritis
03

In context

Shoulder Dislocation

103 studies on the registry are indexed under Shoulder Dislocation; 23 are open to participants now.

This study's enrollment of 80 is above the median of 60 across 70 interventional studies indexed under Shoulder Dislocation.

Browse Shoulder Dislocation studies →

Lead sponsor

Asklepieion Voulas General Hospital is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Shoulder surgery

Exclusion criteria

Exclusion Criteria:

  • patients on opioids
  • diabetes mellitus
  • interscalene block contraindicated
  • patient refusing regional anesthesia techniques
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    Ropivacaine - Tramadol

    Drug: Ropivacaine - Tramadol

  • Active comparator
    Ropivacaine

    Drug: Ropivacaine

Interventions

  • DrugRopivacaine - Tramadol

    Interscalene block using ropivacaine plus tramadol

  • DrugRopivacaine

    Interscalene block using ropivacaine

06

What researchers measure

Primary outcomes

  1. Postoperative analgesia

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. Persistent postoperative pain

    Time frame: 1 month postoperatively, 3 months postoperatively

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

    Time frame: 24 hours postoperatively

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

    Time frame: 24 hours postoperatively

07

Study locations

1 site
  • Asklepieion Hospital of Voula
    Athens, Attica 16673, Greece
08

References and documents

Publications

  • 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. PubMed 23820103 ↗
  • 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. PubMed 16979050 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02182752
Lead sponsor
Asklepieion Voulas General Hospital
Collaborators
Aretaieion University Hospital
Responsible party
Eleftheria Soulioti (MD, Asklepieion Voulas General Hospital) — Principal investigator
First posted
Jul 8, 2014
Start date
Apr 2013
Primary completion
Jan 2016
Last update
Jan 5, 2016
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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