The Effect of Tramadol on Interscalene Brachial Plexus Block

Phase 2

Completed

• Conditions: Shoulder Fracture; Shoulder Dislocation; Rotator Cuff Injury; Shoulder Arthritis
• Interventions: Drug: Ropivacaine - Tramadol; Drug: Ropivacaine

• Registration Number: NCT02182752
• Lead Sponsor: Asklepieion Voulas General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-06-30
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-08
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Last Update Submitted: 2016-01-02
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Shoulder surgery

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine - Tramadol	Ropivacaine - Tramadol	-
Ropivacaine	Ropivacaine	-

Primary Outcome Measures

Name	Time	Method
Postoperative analgesia	24 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Asklepieion Hospital of Voula; 🇬🇷 Athens, Attica, Greece