Trial Outcomes & Findings for Remote Ischemic PreConditioning Effect on Postsurgical Pain (NCT NCT01383317)
NCT ID: NCT01383317
Last Updated: 2018-09-05
Results Overview
Pain intensity and unpleasantness will be measured on postoperative day (POD) 1 and 2 by using a 0-10 verbal scale after asking the subject to cough. Higher scores denotes more intensity and unpleasantness of pain.
COMPLETED
NA
64 participants
Postoperative day 1 and postoperative day 2
2018-09-05
Participant Flow
Participant milestones
| Measure |
RIPC
A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet
|
Sham RIPC
A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Sham RIPC: Disposable sterile thigh tourniquet
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
35
|
|
Overall Study
COMPLETED
|
26
|
33
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
RIPC
A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet
|
Sham RIPC
A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Sham RIPC: Disposable sterile thigh tourniquet
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Remote Ischemic PreConditioning Effect on Postsurgical Pain
Baseline characteristics by cohort
| Measure |
RIPC
n=29 Participants
A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet
|
Sham RIPC
n=35 Participants
A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Sham RIPC: Disposable sterile thigh tourniquet
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.03 years
STANDARD_DEVIATION 11.43 • n=39 Participants
|
59.82 years
STANDARD_DEVIATION 10.62 • n=41 Participants
|
55.52 years
STANDARD_DEVIATION 11.6 • n=35 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
40 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
41 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Postoperative day 1 and postoperative day 2Population: Data was only collected for participants that were alert and conscious.
Pain intensity and unpleasantness will be measured on postoperative day (POD) 1 and 2 by using a 0-10 verbal scale after asking the subject to cough. Higher scores denotes more intensity and unpleasantness of pain.
Outcome measures
| Measure |
RIPC
n=19 Participants
A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet
|
Sham RIPC
n=23 Participants
A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Sham RIPC: Disposable sterile thigh tourniquet
|
|---|---|---|
|
Comparison of Pain Intensity and Unpleasantness Postoperatively
POD 1
|
4.82 units on a scale
Standard Deviation .71
|
4.83 units on a scale
Standard Deviation .62
|
|
Comparison of Pain Intensity and Unpleasantness Postoperatively
POD 2
|
4.05 units on a scale
Standard Deviation 3.08
|
4.81 units on a scale
Standard Deviation 3.14
|
SECONDARY outcome
Timeframe: Postoperative day 1 and postoperative day 2Population: Data was not collected on some participants in both groups because they were unconscious, refused to answer or they were discharged.
All opioids administered during postoperative day (POD) 1 and 2 will be recorded and the number of participants that used opioids will be given.
Outcome measures
| Measure |
RIPC
n=25 Participants
A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet
|
Sham RIPC
n=25 Participants
A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Sham RIPC: Disposable sterile thigh tourniquet
|
|---|---|---|
|
Number of Participants That Consumed Opioids
POD 1
|
20 Participants
|
24 Participants
|
|
Number of Participants That Consumed Opioids
POD 2
|
19 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Postoperative day 1 and postoperative day 2Population: Data was not collected on some participants in both groups because they were unconscious, refused to answer or they were discharged.
All non-opioids analgesics administered during postoperative day 1 and 2 will be recorded and the number of participants that used nonopiods will be given.
Outcome measures
| Measure |
RIPC
n=25 Participants
A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet
|
Sham RIPC
n=25 Participants
A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Sham RIPC: Disposable sterile thigh tourniquet
|
|---|---|---|
|
Consumption of Nonopioid Analgesics
POD 2
|
17 Participants
|
21 Participants
|
|
Consumption of Nonopioid Analgesics
POD 1
|
19 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Postoperative day 1 and postoperative day 2Population: Data was not collected on some participants in both groups because they were unconscious, refused to answer, or they were discharged.
Number of participants that used an antiemetic postoperative day 1 and postoperative day 2 was recorded.
Outcome measures
| Measure |
RIPC
n=25 Participants
A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet
|
Sham RIPC
n=23 Participants
A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Sham RIPC: Disposable sterile thigh tourniquet
|
|---|---|---|
|
Use of Antiemetics
|
25 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Postoperative day 1 and postoperative day 2Population: Data was not collected on some participants in both groups because they were unconscious, refused to answer, or they were discharged.
The Ramsey Sedation Scale (RSS) was used to determine the level of sedation. Th RSS defines the conscious state from a level 1: the patient is anxious, agitated or restless, through the continuum of sedation to a level 6: the patient is completely unresponsive. The score range is from 1-6, with higher scores denoting worse outcomes.
Outcome measures
| Measure |
RIPC
n=23 Participants
A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet
|
Sham RIPC
n=20 Participants
A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Sham RIPC: Disposable sterile thigh tourniquet
|
|---|---|---|
|
Level of Sedation
POD 2
|
2.11 units on a scale
Standard Deviation .65
|
1.95 units on a scale
Standard Deviation .39
|
|
Level of Sedation
POD 1
|
2.29 units on a scale
Standard Deviation .85
|
2.15 units on a scale
Standard Deviation .75
|
SECONDARY outcome
Timeframe: Postoperative day 1 and postoperative day 2Population: Population differs from participant flow, because some participants in each group did not complete the assessment.
The McGill Pain Questionnaire (MPQ) is a three-part pain assessment tool that measures several dimensions of the patient's pain experience. The scale range is 0-78, with higher scores denoting worse outcomes.
Outcome measures
| Measure |
RIPC
n=7 Participants
A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet
|
Sham RIPC
n=11 Participants
A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Sham RIPC: Disposable sterile thigh tourniquet
|
|---|---|---|
|
McGill Pain Sensory
POD 1
|
11.71 units on a scale
Standard Deviation 9.36
|
12.73 units on a scale
Standard Deviation 7.17
|
|
McGill Pain Sensory
POD 2
|
7.14 units on a scale
Standard Deviation 3.18
|
12.82 units on a scale
Standard Deviation 12.21
|
SECONDARY outcome
Timeframe: postoperative day 2Population: Data was not collected on some participants in both groups because they were unconscious, refused to answer, or they were discharged.
Number of participants that had leg pain at 48 hours.
Outcome measures
| Measure |
RIPC
n=27 Participants
A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet
|
Sham RIPC
n=24 Participants
A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Sham RIPC: Disposable sterile thigh tourniquet
|
|---|---|---|
|
Leg Pain at 48 Hours
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Postoperative day 1 and postoperative day 2Population: Data was not collected on some participants in both groups because they were unconscious, refused to answer, or they were discharged.
Participants were questioned to see if they knew what interventional group they belonged to.
Outcome measures
| Measure |
RIPC
n=23 Participants
A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet
|
Sham RIPC
n=20 Participants
A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Sham RIPC: Disposable sterile thigh tourniquet
|
|---|---|---|
|
Patient Verbal Assessment as to Whether They Received Active Treatment or Placebo
Unsure/Unknown
|
20 Participants
|
20 Participants
|
|
Patient Verbal Assessment as to Whether They Received Active Treatment or Placebo
RIPC
|
1 Participants
|
0 Participants
|
|
Patient Verbal Assessment as to Whether They Received Active Treatment or Placebo
Sham
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Postoperative day 1 and postoperative day 2Population: Data was not collected on some participants in both groups because they refused to answer or they were discharged.
Pain unpleasantness will be measured on postoperative day (POD) 1 and 2 by using a 0-10 verbal scale after asking the subject to cough. Higher scores denotes more intensity and unpleasantness of pain.
Outcome measures
| Measure |
RIPC
n=19 Participants
A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet
|
Sham RIPC
n=25 Participants
A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times
Sham RIPC: Disposable sterile thigh tourniquet
|
|---|---|---|
|
Pain Unpleasantness
POD 1
|
4.43 units on a scale
Standard Deviation 3.27
|
5.18 units on a scale
Standard Deviation 3.7
|
|
Pain Unpleasantness
POD 2
|
3.52 units on a scale
Standard Deviation 3.46
|
4.54 units on a scale
Standard Deviation 3.47
|
Adverse Events
RIPC
Sham RIPC
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