N/A
N=50
Pulmonary Function and Interscalene Block
Shoulder Arthroscopy
Bottom Line
View on ClinicalTrials.gov: NCT02181296 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Number of Patients With Paradoxical Diaphragmatic Movement — 16; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ropivacaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Paradoxical Diaphragmatic Movement |
16; 8 | — |
| SECONDARY Percentage Change of Forced Vital Capacity (FVC) From Pre-block Value to Value Measures in PACU |
-33.4; -22 | — |
| SECONDARY Percentage Change in Forced Expired Volume in First Second (FEV1) After the Block |
-28; -20 | — |
| SECONDARY Opioid Requirements for 72 Hours After Surgery |
55; 102 | — |
Summary
The objective of our study is to compare the degree of phrenic nerve blockade after interscalene block using 0.1% ropivacaine or 0.2% ropivacaine. Our hypothesis is that using a lower concentration of local anesthetic will result in lesser degree of phrenic nerve block. 40 patients will be enrolled. Half will receive the block with 0.1% ropivacaine and half with 0.2% ropivacaine. Phrenic nerve and diaphragm function will be assessed by bedside spirometry and ultrasound visualization.
Eligibility Criteria
Inclusion Criteria
- All patients scheduled for shoulder arthroscopy
- ASA physical status between I-III
- Mentally competent and able to give consent for enrollment in the study -
Exclusion Criteria
- Patients who are coagulopathic or currently on anticoagulation medication (except for ASA (acetylsalicylic acid) or NSAIDS)
- Patients with severe pulmonary disease such as asthma or COPD or substantial smoking history suggestive of COPD
- Patients with allergy to local anesthetics or other study drugs
- Patients with chronic opiate use
- Patients with known dysfunction of diaphragm, intercostal muscles, or other neuromuscular disorders affecting respiration
- Inability to speak or understand English language
Data sourced from ClinicalTrials.gov (NCT02181296). 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.