The Effect of Tramadol on Interscalene Brachial Plexus Block

• Register: ClinicalTrials.gov
• Last refreshed on: 18 January 2016
• Main ID: NCT02182752
• Date of registration: 30/06/2014
• Prospective Registration: No
• Primary sponsor: Asklepieion Voulas General Hospital
• Public title: The Effect of Tramadol on Interscalene Brachial Plexus Block
• Scientific title: The Effect of Tramadol on Interscalene Brachial Plexus Block With Ropivacaine in Shoulder Surgery.
• Date of first enrolment: April 2013
• Target sample size: 80
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02182752
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Greece

Key inclusion & exclusion criteria

Inclusion Criteria:

- Shoulder surgery

Exclusion Criteria:

- patients on opioids

- diabetes mellitus

- interscalene block contraindicated

- patient refusing regional anesthesia techniques



Age minimum: 18 Years
Age maximum: 79 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Shoulder Arthritis

Shoulder Fracture

Shoulder Dislocation

Rotator Cuff Injury

Intervention(s)

Drug: Ropivacaine

Drug: Ropivacaine - Tramadol

Primary Outcome(s)

Postoperative analgesia [Time Frame: 24 hours postoperatively]

Secondary Outcome(s)

Evidence of sensory blockade resolution, confirmed by pin-prick test [Time Frame: 24 hours postoperatively]

Evidence of motor blockade resolution, confirmed by elbow - wrist - fingers active movement [Time Frame: 24 hours postoperatively]

Persistent postoperative pain [Time Frame: 1 month postoperatively, 3 months postoperatively]

Secondary ID(s)

3694/27-3-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Aretaieion University Hospital