Clinical Trials Directory

Trials / Completed

CompletedNCT03411343

Interscalene Block Versus Costoclavicular Block for Shoulder Surgery

A Randomized Comparison Between Interscalene and Costoclavicular Infraclavicular Brachial Plexus Blocks For Arthroscopic Shoulder Surgery

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
44 (actual)
Sponsor
University of Chile · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

Interscalene brachial plexus block constitutes the analgesic criterion standard for shoulder surgery. However, it is associated with a high incidence of hemidiaphragmatic paralysis (HDP) that may not be tolerated by patients with chronic pulmonary disease. This randomized controlled trial (RCT) will compare ultrasound-guided interscalene block (ISB) and costoclavicular infraclavicular block (CCICB) in patients undergoing arthroscopic shoulder surgery. The main outcome is static pain at 30 minutes after arrival in the post anesthesia care unit (PACU) as measured by a numerical rate scale (NRS) from 0 to 10. Our research hypothesis is that interscalene and costoclavicular infraclavicular blocks will result in equivalent postoperative analgesia at 30 minutes in the PACU. The equivalence margin is set at 2 points.

Conditions

Interventions

TypeNameDescription
PROCEDUREInterscalene BlockInjection with ultrasound guidance of 20mL of levobupivacaine 0.5% with 5 micrograms of epinephrine per mL in the interscalene groove of the brachial plexus.
PROCEDURECostoclavicular Infraclavicular BlockUltrasound guided brachial plexus block injecting 20mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL in between the cords of the brachial plexus at the costoclavicular infraclavicular space.

Timeline

Start date
2018-04-09
Primary completion
2018-07-06
Completion
2018-07-06
First posted
2018-01-26
Last updated
2018-07-10

Locations

1 site across 1 country: Chile

Source: ClinicalTrials.gov record NCT03411343. Inclusion in this directory is not an endorsement.