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NCT02182752 Clinical Trial

The Effect of Tramadol on Interscalene Brachial Plexus Block

Shoulder Dislocation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02182752
Other study ID # 3694/27-3-13
Secondary ID
Status Completed
Phase Phase 2
First received June 30, 2014
Last updated January 2, 2016
Start date April 2013

Study information
Verified date January 2016
Source Asklepieion Voulas General Hospital
Contact n/a
Is FDA regulated No
Health authority Greece: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 79 Years
Eligibility Inclusion Criteria:

- Shoulder surgery

Exclusion Criteria:

- patients on opioids

- diabetes mellitus

- interscalene block contraindicated

- patient refusing regional anesthesia techniques

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ropivacaine - Tramadol
Interscalene block using ropivacaine plus tramadol
• Ropivacaine
Interscalene block using ropivacaine

Locations
Country Name City State
Greece Asklepieion Hospital of Voula Athens Attica

Sponsors (2)
Lead Sponsor Collaborator
Asklepieion Voulas General Hospital Aretaieion University Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative analgesia 24 hours postoperatively No
Secondary Persistent postoperative pain 1 month postoperatively, 3 months postoperatively No
Secondary Evidence of motor blockade resolution, confirmed by elbow - wrist - fingers active movement 24 hours postoperatively No
Secondary Evidence of sensory blockade resolution, confirmed by pin-prick test 24 hours postoperatively No
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