N/A
N=30
The Effect of Interscalene Peripheral Nerve Block With 0.25% Bupivacaine vs 0.125% Bupivacaine on Lung Function
Diaphragm Paralysis
Bottom Line
View on ClinicalTrials.gov: NCT01429584 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Abnormal Lung Function — 11; 3 participants w/ abnormal diaphragm fxn
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- interscalene nerve block with 0.25% bupivacaine (Drug); interscalene block with 0.125% bupivacaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Abnormal Lung Function |
11; 3 | — |
| SECONDARY Pain Relief |
0; 0.7 | — |
| SECONDARY Satisfaction With Pain Control |
6.6; 6.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- patients presenting for outpatient rotator cuff repair
- adults
- English as the primary language
Exclusion Criteria
- evidence of peripheral nerve damage on affected side
- refusal of peripheral nerve block
- pregnant women
- lung disease, including obstructive sleep apnea
- chronic opioid use
- mental handicap
Data sourced from ClinicalTrials.gov (NCT01429584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.