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Completed

NCT Number: NCT02182752

The Effect of Tramadol on Interscalene Brachial Plexus Block

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.

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Key information

Conditions

Shoulder Fracture Fractures, Bone Joint Diseases Joint Dislocations Musculoskeletal Diseases Rotator Cuff Injuries Rotator Cuff Injury Rupture Shoulder Arthritis Shoulder Dislocation Shoulder Fractures Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asklepieion Hospital of Voula

Athens, Attica, 16673, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Shoulder surgery

Exclusion criteria

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

Treatment and study plan

Ropivacaine - Tramadol

Drug

Interscalene block using ropivacaine plus tramadol

Ropivacaine

Drug

Interscalene block using ropivacaine

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

Sponsors and collaborators

Lead sponsor

Asklepieion Voulas General Hospital

Other Gov

Collaborators

  • Aretaieion University Hospital

Registry information

Official study title

The Effect of Tramadol on Interscalene Brachial Plexus Block With Ropivacaine in Shoulder Surgery.

Important dates

Study start
2013
Primary completion
2016
First posted
Jul 8, 2014
Registry last updated
Jan 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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