Trial Outcomes & Findings for Comparative Effectiveness of Peripheral Nerve Blocks for Outpatient Shoulder Surgery (NCT NCT03309644)
NCT ID: NCT03309644
Last Updated: 2025-01-06
Results Overview
Composite outcome: 1) unplanned admissions on the day of surgery, 2) post-discharge ED visits within 30 days of surgery, 3) readmission within 30 days of surgery, and 4) death from any cause.
Recruitment status
COMPLETED
Target enrollment
1623 participants
Primary outcome timeframe
From day of surgery to 30 days after surgery
Results posted on
2025-01-06
Participant Flow
Participant milestones
| Measure |
Peripheral Nerve Block
Peripheral nerve block
Peripheral nerve blockade: Participants who receive a peripheral nerve block identified through the medical chart.
|
No Peripheral Nerve Block
No peripheral nerve block
No peripheral nerve blockade: Participants who did not receive a peripheral nerve block identified through the medical chart.
|
|---|---|---|
|
Overall Study
STARTED
|
1382
|
241
|
|
Overall Study
COMPLETED
|
1382
|
241
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Six missing values for ASA score, all from the 'No PNB' group
Baseline characteristics by cohort
| Measure |
Peripheral Nerve Block
n=1382 Participants
Peripheral nerve block
Peripheral nerve blockade: Participants who receive a peripheral nerve block identified through the medical chart.
|
No Peripheral Nerve Block
n=241 Participants
No peripheral nerve block
No peripheral nerve blockade: Participants who did not receive a peripheral nerve block identified through the medical chart.
|
Total
n=1623 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.1 years
STANDARD_DEVIATION 15.4 • n=1382 Participants
|
47.1 years
STANDARD_DEVIATION 15.4 • n=241 Participants
|
49.7 years
STANDARD_DEVIATION 15.4 • n=1623 Participants
|
|
Sex: Female, Male
Female
|
455 Participants
n=1382 Participants
|
86 Participants
n=241 Participants
|
541 Participants
n=1623 Participants
|
|
Sex: Female, Male
Male
|
927 Participants
n=1382 Participants
|
155 Participants
n=241 Participants
|
1082 Participants
n=1623 Participants
|
|
Year of Surgery
2011/12
|
517 Participants
n=1382 Participants
|
131 Participants
n=241 Participants
|
648 Participants
n=1623 Participants
|
|
Year of Surgery
2013/14
|
422 Participants
n=1382 Participants
|
74 Participants
n=241 Participants
|
496 Participants
n=1623 Participants
|
|
Year of Surgery
2015/16
|
443 Participants
n=1382 Participants
|
36 Participants
n=241 Participants
|
479 Participants
n=1623 Participants
|
|
Elixhauser comorbidity index
< 0
|
0 Participants
n=1382 Participants
|
0 Participants
n=241 Participants
|
0 Participants
n=1623 Participants
|
|
Elixhauser comorbidity index
0
|
1380 Participants
n=1382 Participants
|
240 Participants
n=241 Participants
|
1620 Participants
n=1623 Participants
|
|
Elixhauser comorbidity index
1-5
|
0 Participants
n=1382 Participants
|
0 Participants
n=241 Participants
|
0 Participants
n=1623 Participants
|
|
Elixhauser comorbidity index
> 5
|
0 Participants
n=1382 Participants
|
0 Participants
n=241 Participants
|
0 Participants
n=1623 Participants
|
|
Elixhauser comorbidity index
Unable to report due to small cell size
|
2 Participants
n=1382 Participants
|
1 Participants
n=241 Participants
|
3 Participants
n=1623 Participants
|
|
Surgery Location
Shoulder joint
|
852 Participants
n=1382 Participants
|
188 Participants
n=241 Participants
|
1040 Participants
n=1623 Participants
|
|
Surgery Location
Rotator cuff
|
528 Participants
n=1382 Participants
|
45 Participants
n=241 Participants
|
573 Participants
n=1623 Participants
|
|
Surgery Location
Shoulder muscle
|
2 Participants
n=1382 Participants
|
8 Participants
n=241 Participants
|
10 Participants
n=1623 Participants
|
|
American Society of Anesthesiology (ASA) Score
< 2
|
1054 Participants
n=1382 Participants • Six missing values for ASA score, all from the 'No PNB' group
|
183 Participants
n=235 Participants • Six missing values for ASA score, all from the 'No PNB' group
|
1237 Participants
n=1617 Participants • Six missing values for ASA score, all from the 'No PNB' group
|
|
American Society of Anesthesiology (ASA) Score
> 2
|
328 Participants
n=1382 Participants • Six missing values for ASA score, all from the 'No PNB' group
|
52 Participants
n=235 Participants • Six missing values for ASA score, all from the 'No PNB' group
|
380 Participants
n=1617 Participants • Six missing values for ASA score, all from the 'No PNB' group
|
|
Surgery type
Arthroscopic
|
1297 Participants
n=1382 Participants
|
212 Participants
n=241 Participants
|
1509 Participants
n=1623 Participants
|
|
Surgery type
Open
|
85 Participants
n=1382 Participants
|
29 Participants
n=241 Participants
|
114 Participants
n=1623 Participants
|
|
Campus
Civic
|
143 Participants
n=1382 Participants
|
24 Participants
n=241 Participants
|
167 Participants
n=1623 Participants
|
|
Campus
General
|
487 Participants
n=1382 Participants
|
129 Participants
n=241 Participants
|
616 Participants
n=1623 Participants
|
|
Campus
Riverside
|
752 Participants
n=1382 Participants
|
88 Participants
n=241 Participants
|
840 Participants
n=1623 Participants
|
PRIMARY outcome
Timeframe: From day of surgery to 30 days after surgeryComposite outcome: 1) unplanned admissions on the day of surgery, 2) post-discharge ED visits within 30 days of surgery, 3) readmission within 30 days of surgery, and 4) death from any cause.
Outcome measures
| Measure |
Peripheral Nerve Block
n=1382 Participants
Peripheral nerve block
Peripheral nerve blockade: Participants who receive a peripheral nerve block identified through the medical chart.
|
No Peripheral Nerve Block
n=241 Participants
No peripheral nerve block
No peripheral nerve blockade: Participants who did not receive a peripheral nerve block identified through the medical chart.
|
|---|---|---|
|
Postoperative Complication
Composite outcome
|
130 Participants
|
23 Participants
|
|
Postoperative Complication
Unplanned admission
|
20 Participants
|
12 Participants
|
|
Postoperative Complication
Readmission within 30 days
|
11 Participants
|
3 Participants
|
|
Postoperative Complication
ED visits within 30 days
|
111 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: From day of surgery to 30 days after surgeryCalculated using validated algorithms
Outcome measures
| Measure |
Peripheral Nerve Block
n=1357 Participants
Peripheral nerve block
Peripheral nerve blockade: Participants who receive a peripheral nerve block identified through the medical chart.
|
No Peripheral Nerve Block
n=231 Participants
No peripheral nerve block
No peripheral nerve blockade: Participants who did not receive a peripheral nerve block identified through the medical chart.
|
|---|---|---|
|
Health System Costs in the 30 Days After Surgery
|
0 dollars
Interval 0.0 to 0.0
|
0 dollars
Interval 0.0 to 0.0
|
Adverse Events
Peripheral Nerve Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Peripheral Nerve Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place