Trial Outcomes & Findings for Post- Surgery Recovery: Nerve Blocks w/ Sedation vs. Nerve Block w/ Either Sedation/Gen. Anesthesia (NCT NCT02602080)
NCT ID: NCT02602080
Last Updated: 2019-10-02
Results Overview
Yes/no response to whether patient had nausea in the PACU 1 hour after admission. If yes, investigators will seek out intensity
Recruitment status
COMPLETED
Target enrollment
55 participants
Primary outcome timeframe
1 hour after surgery
Results posted on
2019-10-02
Participant Flow
55 patients were enrolled in the study based on the anesthesia they will be receiving and their surgical type. Patients weren't excluded prior to group assignment. Patients were excluded if protocol deviations occurred, pending the severity of the deviation.
Participant milestones
| Measure |
FA Patients Under Popliteal Block + Spinal + Sedation
Foot and ankle patients under popliteal block+ spinal+ sedation
|
TSA Patients Under Brachial Plexus Block + General (LMA)
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
|
TSA Patients Under Brachial Plexus Block + Sedation
Total shoulder arthroplasty patients under brachial plexus block + sedation
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
16
|
18
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
3
|
Reasons for withdrawal
| Measure |
FA Patients Under Popliteal Block + Spinal + Sedation
Foot and ankle patients under popliteal block+ spinal+ sedation
|
TSA Patients Under Brachial Plexus Block + General (LMA)
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
|
TSA Patients Under Brachial Plexus Block + Sedation
Total shoulder arthroplasty patients under brachial plexus block + sedation
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
6
|
1
|
3
|
Baseline Characteristics
Post- Surgery Recovery: Nerve Blocks w/ Sedation vs. Nerve Block w/ Either Sedation/Gen. Anesthesia
Baseline characteristics by cohort
| Measure |
FA Patients Under Popliteal Block + Spinal + Sedation
n=15 Participants
Foot and ankle patients under popliteal block+ spinal+ sedation
|
TSA Patients Under Brachial Plexus Block + General (LMA)
n=15 Participants
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
|
TSA Patients Under Brachial Plexus Block + Sedation
n=15 Participants
Total shoulder arthroplasty patients under brachial plexus block + sedation
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 15 • n=5 Participants
|
71 years
STANDARD_DEVIATION 8 • n=7 Participants
|
68 years
STANDARD_DEVIATION 9 • n=5 Participants
|
65 years
STANDARD_DEVIATION 11 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
45 participants
n=4 Participants
|
|
BMI
|
25 kg/m^2
STANDARD_DEVIATION 4 • n=5 Participants
|
26 kg/m^2
STANDARD_DEVIATION 4 • n=7 Participants
|
29 kg/m^2
STANDARD_DEVIATION 3 • n=5 Participants
|
27 kg/m^2
STANDARD_DEVIATION 4 • n=4 Participants
|
|
American Society of Anesthesiologists (ASA) physical status (PS)
ASA PS I (normal healthy patient)
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
American Society of Anesthesiologists (ASA) physical status (PS)
ASA PS II (patient with mild systemic disease)
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
American Society of Anesthesiologists (ASA) physical status (PS)
ASA PS III (patient with severe systemic disease)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Current smoking status
Yes (smoker)
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Current smoking status
No (non-smoker)
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
History of post-operative nausea and vomiting (PONV)
Yes
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
History of post-operative nausea and vomiting (PONV)
No
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
History of post-operative nausea and vomiting (PONV)
No prior surgery
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Anesthesia Time
|
169 min
STANDARD_DEVIATION 51 • n=5 Participants
|
132 min
STANDARD_DEVIATION 11 • n=7 Participants
|
133 min
STANDARD_DEVIATION 18 • n=5 Participants
|
145 min
STANDARD_DEVIATION 27 • n=4 Participants
|
PRIMARY outcome
Timeframe: 1 hour after surgeryPopulation: Patients receiving either block+spinal+sedation for foot and ankle surgery or block+general or block+sedation for total shoulder arthroscopy
Yes/no response to whether patient had nausea in the PACU 1 hour after admission. If yes, investigators will seek out intensity
Outcome measures
| Measure |
FA Patients Under Popliteal Block + Spinal + Sedation
n=15 Participants
Foot and ankle patients under popliteal block+ spinal+ sedation
|
TSA Patients Under Brachial Plexus Block + General (LMA)
n=15 Participants
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
|
TSA Patients Under Brachial Plexus Block + Sedation
n=15 Participants
Total shoulder arthroplasty patients under brachial plexus block + sedation
|
|---|---|---|---|
|
Number of Participants With Nausea 1 Hour After Post-anesthesia Care Unit (PACU) Admission
Yes
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Nausea 1 Hour After Post-anesthesia Care Unit (PACU) Admission
No
|
14 Participants
|
15 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Average 2 hours after surgery (at discharge from the recovery room after surgery)Population: Patients receiving either block+spinal+sedation for foot and ankle surgery or block+general or block+sedation for total shoulder arthroscopy
Yes/no question. If yes, the investigators will then seek intensity of nausea.
Outcome measures
| Measure |
FA Patients Under Popliteal Block + Spinal + Sedation
n=15 Participants
Foot and ankle patients under popliteal block+ spinal+ sedation
|
TSA Patients Under Brachial Plexus Block + General (LMA)
n=15 Participants
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
|
TSA Patients Under Brachial Plexus Block + Sedation
n=15 Participants
Total shoulder arthroplasty patients under brachial plexus block + sedation
|
|---|---|---|---|
|
Number of Participants With Nausea
Yes
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Nausea
No
|
13 Participants
|
15 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: 1 hour after surgeryOn an 11 grade Likert scale (0=no nausea, 10=worst possible nausea)
Outcome measures
| Measure |
FA Patients Under Popliteal Block + Spinal + Sedation
n=15 Participants
Foot and ankle patients under popliteal block+ spinal+ sedation
|
TSA Patients Under Brachial Plexus Block + General (LMA)
n=15 Participants
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
|
TSA Patients Under Brachial Plexus Block + Sedation
n=15 Participants
Total shoulder arthroplasty patients under brachial plexus block + sedation
|
|---|---|---|---|
|
Intensity of Nausea
0
|
14 Participants
|
15 Participants
|
14 Participants
|
|
Intensity of Nausea
1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Intensity of Nausea
2
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Intensity of Nausea
3-7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Intensity of Nausea
8
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Intensity of Nausea
9-10
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 2 hours after surgeryPopulation: Patients receiving either block+spinal+sedation for foot and ankle surgery or block+general or block+sedation for total shoulder arthroscopy
On a 11 grade Likert scale (0=no nausea, 10=worst possible nausea)
Outcome measures
| Measure |
FA Patients Under Popliteal Block + Spinal + Sedation
n=15 Participants
Foot and ankle patients under popliteal block+ spinal+ sedation
|
TSA Patients Under Brachial Plexus Block + General (LMA)
n=15 Participants
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
|
TSA Patients Under Brachial Plexus Block + Sedation
n=15 Participants
Total shoulder arthroplasty patients under brachial plexus block + sedation
|
|---|---|---|---|
|
Intensity of Nausea
0
|
13 Participants
|
15 Participants
|
13 Participants
|
|
Intensity of Nausea
1
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Intensity of Nausea
2-4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Intensity of Nausea
5
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Intensity of Nausea
6-8
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Intensity of Nausea
9
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Intensity of Nausea
10
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Duration of stay in recovery room after surgery (average 2 hours)Yes/no question if antiemetic consumption occured.
Outcome measures
| Measure |
FA Patients Under Popliteal Block + Spinal + Sedation
n=15 Participants
Foot and ankle patients under popliteal block+ spinal+ sedation
|
TSA Patients Under Brachial Plexus Block + General (LMA)
n=15 Participants
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
|
TSA Patients Under Brachial Plexus Block + Sedation
n=15 Participants
Total shoulder arthroplasty patients under brachial plexus block + sedation
|
|---|---|---|---|
|
Antiemetic Consumption
Yes
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Antiemetic Consumption
No
|
13 Participants
|
15 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 1 hour after surgeryYes/no question. If yes, the investigators will then seek intensity of emesis
Outcome measures
| Measure |
FA Patients Under Popliteal Block + Spinal + Sedation
n=15 Participants
Foot and ankle patients under popliteal block+ spinal+ sedation
|
TSA Patients Under Brachial Plexus Block + General (LMA)
n=15 Participants
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
|
TSA Patients Under Brachial Plexus Block + Sedation
n=15 Participants
Total shoulder arthroplasty patients under brachial plexus block + sedation
|
|---|---|---|---|
|
Number of Participants With Emesis
Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emesis
No
|
15 Participants
|
15 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Average 2 hours after surgery (at discharge from the recovery room after surgery)Yes/no question. If yes, the investigators will then seek intensity of emesis
Outcome measures
| Measure |
FA Patients Under Popliteal Block + Spinal + Sedation
n=15 Participants
Foot and ankle patients under popliteal block+ spinal+ sedation
|
TSA Patients Under Brachial Plexus Block + General (LMA)
n=15 Participants
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
|
TSA Patients Under Brachial Plexus Block + Sedation
n=15 Participants
Total shoulder arthroplasty patients under brachial plexus block + sedation
|
|---|---|---|---|
|
Number of Participants With Emesis
Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emesis
No
|
15 Participants
|
15 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: PACU before discharge, an average of 2 hoursLowest satisfaction score on a 11 grade Likert scale (0=no satisfaction, 10=maximal satisfaction).
Outcome measures
| Measure |
FA Patients Under Popliteal Block + Spinal + Sedation
n=15 Participants
Foot and ankle patients under popliteal block+ spinal+ sedation
|
TSA Patients Under Brachial Plexus Block + General (LMA)
n=15 Participants
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
|
TSA Patients Under Brachial Plexus Block + Sedation
n=15 Participants
Total shoulder arthroplasty patients under brachial plexus block + sedation
|
|---|---|---|---|
|
Number of Participants Satisfied With Anesthesia
|
10 score on a scale
Interval 10.0 to 10.0
|
10 score on a scale
Interval 10.0 to 10.0
|
10 score on a scale
Interval 9.0 to 10.0
|
SECONDARY outcome
Timeframe: PACU stay before discharge (average 2 hours)Yes/no for patients that were given opioids for pain management in the PACU. If opioids were consumed, the oral morphine equivalents for the patients taking opioids was totaled.
Outcome measures
| Measure |
FA Patients Under Popliteal Block + Spinal + Sedation
n=15 Participants
Foot and ankle patients under popliteal block+ spinal+ sedation
|
TSA Patients Under Brachial Plexus Block + General (LMA)
n=15 Participants
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
|
TSA Patients Under Brachial Plexus Block + Sedation
n=15 Participants
Total shoulder arthroplasty patients under brachial plexus block + sedation
|
|---|---|---|---|
|
Patients Receiving Opioids in the PACU
Yes
|
4 Participants
|
5 Participants
|
8 Participants
|
|
Patients Receiving Opioids in the PACU
No
|
11 Participants
|
10 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Duration of PACU stay (Average 2 hours)Total opioid dose taken by patients who took any opioids in the PACU, measured in oral morphine equivalents (mg OME)
Outcome measures
| Measure |
FA Patients Under Popliteal Block + Spinal + Sedation
n=4 Participants
Foot and ankle patients under popliteal block+ spinal+ sedation
|
TSA Patients Under Brachial Plexus Block + General (LMA)
n=5 Participants
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
|
TSA Patients Under Brachial Plexus Block + Sedation
n=8 Participants
Total shoulder arthroplasty patients under brachial plexus block + sedation
|
|---|---|---|---|
|
Opioid Dose Among Patients Receiving Opioids in the PACU
|
22.5 mg OME
Interval 15.0 to 36.2
|
15 mg OME
Interval 10.0 to 19.5
|
18.9 mg OME
Interval 13.4 to 26.7
|
Adverse Events
FA Patients Under Popliteal Block + Spinal + Sedation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TSA Patients Under Brachial Plexus Block + General (LMA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TSA Patients Under Brachial Plexus Block + Sedation
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