Clinical Trials Directory

Trials / Completed

CompletedNCT01429584

The Effect of Interscalene Peripheral Nerve Block With 0.25% Bupivacaine vs 0.125% Bupivacaine on Lung Function

Investigation Into the Effect of 0.25% Bupivacaine for Interscalene Peripheral Nerve Block vs 0.125% Bupivacaine on Pulmonary Function

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
University of Utah · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

Peripheral nerve blocks are used to provide post-operative pain relief. Nerve blocks in the neck, in the interscalene area, provide pain relief after shoulder surgery but can cause temporary weakness or paralysis of the diaphragm. The investigators hypothesized that a lower concentration of bupivacaine would cause less weakness of the diaphragm but still provide good pain relief. Lung function and pain control was studied after interscalene peripheral nerve block with 20 milliliters of 0.25% bupivacaine or 0.125% bupivacaine.

Detailed description

Prior to placement of interscalene brachial plexus peripheral nerve block (ISPNB), diaphragm function was assessed using ultrasound as normal, no movement, or paradoxical. Room air pulse oximetry (SpO2) was recorded. Patients were randomized to receive either 0.25% bupivacaine or 0.125% bupivacaine. ISPNB was performed using a coded syringe of the study drug, so that the anesthesiologists performing the nerve block, the patient, and the nurses assessing the patient were blinded as to the concentration. Patients were given a general endotracheal anesthesia for rotator cuff repair, and opioids were administered at the discretion of the attending anesthesiologist. When patients met criteria for PACU discharge, diaphragm function was again assessed using ultrasound and room air SpO2 was recorded.

Conditions

Interventions

TypeNameDescription
DRUGinterscalene nerve block with 0.25% bupivacaineinterscalene nerve block performed with 20 ml of 0.25% bupivacaine
DRUGinterscalene block with 0.125% bupivacaineinterscalene block with 20 ml of 0.125% bupivacaine

Timeline

Start date
2008-05-01
Primary completion
2010-02-01
Completion
2010-02-01
First posted
2011-09-07
Last updated
2013-12-19
Results posted
2013-12-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01429584. Inclusion in this directory is not an endorsement.