Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post- Surgery Recovery: Nerve Blocks w/ Sedation vs. Nerve Block w/ Either Sedation/Gen. Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02602080
Recruitment Status : Completed
First Posted : November 11, 2015
Results First Posted : February 4, 2019
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Nausea
Emesis
Enrollment 55
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title FA Patients Under Popliteal Block + Spinal + Sedation TSA Patients Under Brachial Plexus Block + General (LMA) TSA Patients Under Brachial Plexus Block + Sedation
Hide Arm/Group Description Foot and ankle patients under popliteal block+ spinal+ sedation Total shoulder arthroscopy patients under brachial plexus block + general (LMA) Total shoulder arthroplasty patients under brachial plexus block + sedation
Period Title: Overall Study
Started 21 16 18
Completed 15 15 15
Not Completed 6 1 3
Reason Not Completed
Protocol Violation             6             1             3
Arm/Group Title FA Patients Under Popliteal Block + Spinal + Sedation TSA Patients Under Brachial Plexus Block + General (LMA) TSA Patients Under Brachial Plexus Block + Sedation Total
Hide Arm/Group Description Foot and ankle patients under popliteal block+ spinal+ sedation Total shoulder arthroscopy patients under brachial plexus block + general (LMA) Total shoulder arthroplasty patients under brachial plexus block + sedation Total of all reporting groups
Overall Number of Baseline Participants 15 15 15 45
Hide Baseline Analysis Population Description
Patients contributed baseline units by patient report (history of PONV, motion sickness, smoking status) and by granting access to their charts (age, gender, race, ethnicity, ASA status, BMI).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 45 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
  80.0%
3
  20.0%
5
  33.3%
20
  44.4%
>=65 years
3
  20.0%
12
  80.0%
10
  66.7%
25
  55.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 15 participants 45 participants
55  (15) 71  (8) 68  (9) 65  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 45 participants
Female
12
  80.0%
11
  73.3%
8
  53.3%
31
  68.9%
Male
3
  20.0%
4
  26.7%
7
  46.7%
14
  31.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 45 participants
Hispanic or Latino
1
   6.7%
0
   0.0%
1
   6.7%
2
   4.4%
Not Hispanic or Latino
13
  86.7%
14
  93.3%
14
  93.3%
41
  91.1%
Unknown or Not Reported
1
   6.7%
1
   6.7%
0
   0.0%
2
   4.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 45 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  13.3%
0
   0.0%
0
   0.0%
2
   4.4%
Native Hawaiian or Other Pacific Islander
1
   6.7%
0
   0.0%
0
   0.0%
1
   2.2%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
10
  66.7%
14
  93.3%
13
  86.7%
37
  82.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
  13.3%
1
   6.7%
2
  13.3%
5
  11.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 15 participants 45 participants
15 15 15 45
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 15 participants 15 participants 15 participants 45 participants
25  (4) 26  (4) 29  (3) 27  (4)
American Society of Anesthesiologists (ASA) physical status (PS)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 45 participants
ASA PS I (normal healthy patient)
4
  26.7%
1
   6.7%
2
  13.3%
7
  15.6%
ASA PS II (patient with mild systemic disease)
11
  73.3%
13
  86.7%
10
  66.7%
34
  75.6%
ASA PS III (patient with severe systemic disease)
0
   0.0%
1
   6.7%
3
  20.0%
4
   8.9%
Current smoking status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 45 participants
Yes (smoker)
2
  13.3%
1
   6.7%
1
   6.7%
4
   8.9%
No (non-smoker)
13
  86.7%
14
  93.3%
14
  93.3%
41
  91.1%
History of post-operative nausea and vomiting (PONV)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 45 participants
Yes
3
  20.0%
2
  13.3%
4
  26.7%
9
  20.0%
No
12
  80.0%
12
  80.0%
10
  66.7%
34
  75.6%
No prior surgery
0
   0.0%
1
   6.7%
1
   6.7%
2
   4.4%
Anesthesia Time  
Mean (Standard Deviation)
Unit of measure:  Min
Number Analyzed 15 participants 15 participants 15 participants 45 participants
169  (51) 132  (11) 133  (18) 145  (27)
1.Primary Outcome
Title Number of Participants With Nausea 1 Hour After Post-anesthesia Care Unit (PACU) Admission
Hide Description Yes/no response to whether patient had nausea in the PACU 1 hour after admission. If yes, investigators will seek out intensity
Time Frame 1 hour after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Patients receiving either block+spinal+sedation for foot and ankle surgery or block+general or block+sedation for total shoulder arthroscopy
Arm/Group Title FA Patients Under Popliteal Block + Spinal + Sedation TSA Patients Under Brachial Plexus Block + General (LMA) TSA Patients Under Brachial Plexus Block + Sedation
Hide Arm/Group Description:
Foot and ankle patients under popliteal block+ spinal+ sedation
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
Total shoulder arthroplasty patients under brachial plexus block + sedation
Overall Number of Participants Analyzed 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
1
   6.7%
0
   0.0%
1
   6.7%
No
14
  93.3%
15
 100.0%
14
  93.3%
2.Primary Outcome
Title Number of Participants With Nausea
Hide Description Yes/no question. If yes, the investigators will then seek intensity of nausea.
Time Frame Average 2 hours after surgery (at discharge from the recovery room after surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients receiving either block+spinal+sedation for foot and ankle surgery or block+general or block+sedation for total shoulder arthroscopy
Arm/Group Title FA Patients Under Popliteal Block + Spinal + Sedation TSA Patients Under Brachial Plexus Block + General (LMA) TSA Patients Under Brachial Plexus Block + Sedation
Hide Arm/Group Description:
Foot and ankle patients under popliteal block+ spinal+ sedation
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
Total shoulder arthroplasty patients under brachial plexus block + sedation
Overall Number of Participants Analyzed 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
2
  13.3%
0
   0.0%
2
  13.3%
No
13
  86.7%
15
 100.0%
13
  86.7%
3.Primary Outcome
Title Intensity of Nausea
Hide Description On an 11 grade Likert scale (0=no nausea, 10=worst possible nausea)
Time Frame 1 hour after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FA Patients Under Popliteal Block + Spinal + Sedation TSA Patients Under Brachial Plexus Block + General (LMA) TSA Patients Under Brachial Plexus Block + Sedation
Hide Arm/Group Description:
Foot and ankle patients under popliteal block+ spinal+ sedation
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
Total shoulder arthroplasty patients under brachial plexus block + sedation
Overall Number of Participants Analyzed 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
0
14
  93.3%
15
 100.0%
14
  93.3%
1
0
   0.0%
0
   0.0%
0
   0.0%
2
0
   0.0%
0
   0.0%
1
   6.7%
3-7
0
   0.0%
0
   0.0%
0
   0.0%
8
1
   6.7%
0
   0.0%
0
   0.0%
9-10
0
   0.0%
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Intensity of Nausea
Hide Description On a 11 grade Likert scale (0=no nausea, 10=worst possible nausea)
Time Frame 2 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Patients receiving either block+spinal+sedation for foot and ankle surgery or block+general or block+sedation for total shoulder arthroscopy
Arm/Group Title FA Patients Under Popliteal Block + Spinal + Sedation TSA Patients Under Brachial Plexus Block + General (LMA) TSA Patients Under Brachial Plexus Block + Sedation
Hide Arm/Group Description:
Foot and ankle patients under popliteal block+ spinal+ sedation
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
Total shoulder arthroplasty patients under brachial plexus block + sedation
Overall Number of Participants Analyzed 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
0
13
  86.7%
15
 100.0%
13
  86.7%
1
0
   0.0%
0
   0.0%
1
   6.7%
2-4
0
   0.0%
0
   0.0%
0
   0.0%
5
1
   6.7%
0
   0.0%
1
   6.7%
6-8
0
   0.0%
0
   0.0%
0
   0.0%
9
1
   6.7%
0
   0.0%
0
   0.0%
10
0
   0.0%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Antiemetic Consumption
Hide Description Yes/no question if antiemetic consumption occured.
Time Frame Duration of stay in recovery room after surgery (average 2 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FA Patients Under Popliteal Block + Spinal + Sedation TSA Patients Under Brachial Plexus Block + General (LMA) TSA Patients Under Brachial Plexus Block + Sedation
Hide Arm/Group Description:
Foot and ankle patients under popliteal block+ spinal+ sedation
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
Total shoulder arthroplasty patients under brachial plexus block + sedation
Overall Number of Participants Analyzed 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
2
  13.3%
0
   0.0%
0
   0.0%
No
13
  86.7%
15
 100.0%
15
 100.0%
6.Secondary Outcome
Title Number of Participants With Emesis
Hide Description Yes/no question. If yes, the investigators will then seek intensity of emesis
Time Frame 1 hour after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FA Patients Under Popliteal Block + Spinal + Sedation TSA Patients Under Brachial Plexus Block + General (LMA) TSA Patients Under Brachial Plexus Block + Sedation
Hide Arm/Group Description:
Foot and ankle patients under popliteal block+ spinal+ sedation
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
Total shoulder arthroplasty patients under brachial plexus block + sedation
Overall Number of Participants Analyzed 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
0
   0.0%
0
   0.0%
0
   0.0%
No
15
 100.0%
15
 100.0%
15
 100.0%
7.Secondary Outcome
Title Number of Participants With Emesis
Hide Description Yes/no question. If yes, the investigators will then seek intensity of emesis
Time Frame Average 2 hours after surgery (at discharge from the recovery room after surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FA Patients Under Popliteal Block + Spinal + Sedation TSA Patients Under Brachial Plexus Block + General (LMA) TSA Patients Under Brachial Plexus Block + Sedation
Hide Arm/Group Description:
Foot and ankle patients under popliteal block+ spinal+ sedation
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
Total shoulder arthroplasty patients under brachial plexus block + sedation
Overall Number of Participants Analyzed 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
0
   0.0%
0
   0.0%
0
   0.0%
No
15
 100.0%
15
 100.0%
15
 100.0%
8.Secondary Outcome
Title Number of Participants Satisfied With Anesthesia
Hide Description Lowest satisfaction score on a 11 grade Likert scale (0=no satisfaction, 10=maximal satisfaction).
Time Frame PACU before discharge, an average of 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FA Patients Under Popliteal Block + Spinal + Sedation TSA Patients Under Brachial Plexus Block + General (LMA) TSA Patients Under Brachial Plexus Block + Sedation
Hide Arm/Group Description:
Foot and ankle patients under popliteal block+ spinal+ sedation
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
Total shoulder arthroplasty patients under brachial plexus block + sedation
Overall Number of Participants Analyzed 15 15 15
Mean (Inter-Quartile Range)
Unit of Measure: score on a scale
10
(10 to 10)
10
(10 to 10)
10
(9 to 10)
9.Secondary Outcome
Title Patients Receiving Opioids in the PACU
Hide Description 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.
Time Frame PACU stay before discharge (average 2 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FA Patients Under Popliteal Block + Spinal + Sedation TSA Patients Under Brachial Plexus Block + General (LMA) TSA Patients Under Brachial Plexus Block + Sedation
Hide Arm/Group Description:
Foot and ankle patients under popliteal block+ spinal+ sedation
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
Total shoulder arthroplasty patients under brachial plexus block + sedation
Overall Number of Participants Analyzed 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
4
  26.7%
5
  33.3%
8
  53.3%
No
11
  73.3%
10
  66.7%
7
  46.7%
10.Secondary Outcome
Title Opioid Dose Among Patients Receiving Opioids in the PACU
Hide Description Total opioid dose taken by patients who took any opioids in the PACU, measured in oral morphine equivalents (mg OME)
Time Frame Duration of PACU stay (Average 2 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FA Patients Under Popliteal Block + Spinal + Sedation TSA Patients Under Brachial Plexus Block + General (LMA) TSA Patients Under Brachial Plexus Block + Sedation
Hide Arm/Group Description:
Foot and ankle patients under popliteal block+ spinal+ sedation
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
Total shoulder arthroplasty patients under brachial plexus block + sedation
Overall Number of Participants Analyzed 4 5 8
Mean (Inter-Quartile Range)
Unit of Measure: mg OME
22.5
(15 to 36.2)
15
(10 to 19.5)
18.9
(13.4 to 26.7)
Time Frame Adverse event data was collected during the period of enrollment and patient participation (Post-Operative Day 0 to Post-Operative Day 1).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FA Patients Under Popliteal Block + Spinal + Sedation TSA Patients Under Brachial Plexus Block + General (LMA) TSA Patients Under Brachial Plexus Block + Sedation
Hide Arm/Group Description Foot and ankle patients under popliteal block+ spinal+ sedation Total shoulder arthroscopy patients under brachial plexus block + general (LMA) Total shoulder arthroplasty patients under brachial plexus block + sedation
All-Cause Mortality
FA Patients Under Popliteal Block + Spinal + Sedation TSA Patients Under Brachial Plexus Block + General (LMA) TSA Patients Under Brachial Plexus Block + Sedation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
FA Patients Under Popliteal Block + Spinal + Sedation TSA Patients Under Brachial Plexus Block + General (LMA) TSA Patients Under Brachial Plexus Block + Sedation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
FA Patients Under Popliteal Block + Spinal + Sedation TSA Patients Under Brachial Plexus Block + General (LMA) TSA Patients Under Brachial Plexus Block + Sedation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Limitations included generalizability, as the study was limited by anesthetic regimen, type of surgery, and patient population. We felt it was inappropriate to randomize general or spinal anesthesia for the purpose of this study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: George Birch
Organization: Hospital for Special Surgery
Phone: 212-774-7377
EMail: birchg@hss.edu
Layout table for additonal information
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02602080    
Other Study ID Numbers: 2015-397
First Submitted: November 4, 2015
First Posted: November 11, 2015
Results First Submitted: June 28, 2018
Results First Posted: February 4, 2019
Last Update Posted: October 2, 2019