Trial Outcomes & Findings for Use of On-Q Pump for Pain Post C-Section (NCT NCT02579629)
NCT ID: NCT02579629
Last Updated: 2020-10-14
Results Overview
The intensity of pain during cough will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with "no pain" at the bottom and "worst imaginable pain" at the top. Pain scores range from 0-100, so the change in pain score (post- minus pre-) can theoretically range from -100 to 100. A negative score indicates an improvement in pain. Higher scores indicate higher intensities of pain.
COMPLETED
PHASE4
64 participants
2 hours post baseline, 6, 12, 24, 48, 72 hours post baseline
2020-10-14
Participant Flow
Participants were enrolled between July 2015 and July 2019.
Participant milestones
| Measure |
Ropivacaine 0.1%
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Ropivacaine 0.2%
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Normal Saline
Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
20
|
22
|
|
Overall Study
COMPLETED
|
20
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
Reasons for withdrawal
| Measure |
Ropivacaine 0.1%
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Ropivacaine 0.2%
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Normal Saline
Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Screen Failure
|
2
|
0
|
2
|
Baseline Characteristics
Use of On-Q Pump for Pain Post C-Section
Baseline characteristics by cohort
| Measure |
Ropivacaine 0.1%
n=20 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Ropivacaine 0.2%
n=19 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Normal Saline
n=20 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.3 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
32.1 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
31.9 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
31.2 years
STANDARD_DEVIATION 5.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 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
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
19 participants
n=7 Participants
|
20 participants
n=5 Participants
|
59 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 hours post baseline, 6, 12, 24, 48, 72 hours post baselinePopulation: The drop of participants at 72 hours reflects patients who were discharged early, prior to the 72 hr Visit. Other missing values occurred when patients could not be located at the scheduled time because they were not in their room.
The intensity of pain during cough will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with "no pain" at the bottom and "worst imaginable pain" at the top. Pain scores range from 0-100, so the change in pain score (post- minus pre-) can theoretically range from -100 to 100. A negative score indicates an improvement in pain. Higher scores indicate higher intensities of pain.
Outcome measures
| Measure |
Ropivacaine 0.1%
n=20 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Ropivacaine 0.2%
n=19 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Normal Saline
n=20 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
|---|---|---|---|
|
Change in Pain Scores During Cough From Baseline
Change in score at 72-hours post baseline
|
6.5 score on a scale
Interval -1.5 to 32.25
|
0 score on a scale
Interval 0.0 to 20.0
|
3 score on a scale
Interval -1.5 to 15.0
|
|
Change in Pain Scores During Cough From Baseline
Change in score at 2-hours post baseline
|
4 score on a scale
Interval 0.0 to 15.0
|
1 score on a scale
Interval -4.5 to 18.5
|
20.5 score on a scale
Interval 4.75 to 36.25
|
|
Change in Pain Scores During Cough From Baseline
Change in score at 6-hours post baseline
|
10 score on a scale
Interval 4.0 to 27.0
|
3 score on a scale
Interval -8.0 to 10.0
|
10.5 score on a scale
Interval 3.75 to 30.75
|
|
Change in Pain Scores During Cough From Baseline
Change in score at 12-hours post baseline
|
14.5 score on a scale
Interval 4.0 to 26.0
|
2 score on a scale
Interval -4.0 to 13.0
|
15.5 score on a scale
Interval 9.75 to 41.25
|
|
Change in Pain Scores During Cough From Baseline
Change in score at 24-hours post baseline
|
20 score on a scale
Interval 1.5 to 45.5
|
27 score on a scale
Interval 0.0 to 36.0
|
15.5 score on a scale
Interval 9.75 to 41.25
|
|
Change in Pain Scores During Cough From Baseline
Change in score at 48-hours post baseline
|
13 score on a scale
Interval 6.5 to 39.75
|
2 score on a scale
Interval -2.5 to 26.5
|
15 score on a scale
Interval -0.5 to 35.75
|
PRIMARY outcome
Timeframe: Baseline (At zero time, the time of the first dosing using the On-Q catheter), 2, 6, 12, 24, 48, 72 hours post baselinePopulation: The drop of participants at 72 hours reflects patients who were discharged early, prior to the 72 hr Visit. Other missing values occurred when patients could not be located at the scheduled time because they were not in their room.
The intensity of pain during 20° straight leg raise will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with "no pain" at the bottom and "worst imaginable pain" at the top. Higher scores indicate higher intensities of pain.
Outcome measures
| Measure |
Ropivacaine 0.1%
n=20 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Ropivacaine 0.2%
n=19 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Normal Saline
n=20 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
|---|---|---|---|
|
Change in Pain Scores During 20°Straight Leg Raise
Change in score at 6-hours post baseline
|
8 score on a scale
Interval 1.0 to 18.0
|
0 score on a scale
Interval -2.0 to 6.5
|
5 score on a scale
Interval 0.75 to 19.5
|
|
Change in Pain Scores During 20°Straight Leg Raise
Change in score at 2-hours post baseline
|
4 score on a scale
Interval 1.5 to 12.5
|
5 score on a scale
Interval 0.0 to 17.5
|
10.5 score on a scale
Interval 1.75 to 31.0
|
|
Change in Pain Scores During 20°Straight Leg Raise
Change in score at 12-hours post baseline
|
-6.5 score on a scale
Interval -22.5 to 0.0
|
0 score on a scale
Interval -2.5 to 1.5
|
-6.5 score on a scale
Interval -28.5 to 0.0
|
|
Change in Pain Scores During 20°Straight Leg Raise
Change in score at 24-hours post baseline
|
9 score on a scale
Interval 0.75 to 23.75
|
0 score on a scale
Interval 0.0 to 21.25
|
16 score on a scale
Interval 0.75 to 29.0
|
|
Change in Pain Scores During 20°Straight Leg Raise
Change in score at 48-hours post baseline
|
9.5 score on a scale
Interval 0.75 to 21.25
|
3 score on a scale
Interval 0.0 to 22.5
|
17 score on a scale
Interval 0.75 to 27.0
|
|
Change in Pain Scores During 20°Straight Leg Raise
Change in score at 72-hours post baseline
|
1 score on a scale
Interval -3.0 to 8.25
|
3 score on a scale
Interval 0.0 to 10.0
|
2.5 score on a scale
Interval 0.0 to 12.0
|
PRIMARY outcome
Timeframe: 6 weeks, 3 monthsPopulation: The difference reflects the number of patients who were lost to follow up at 6 weeks and 3 months.
Post-operative pain will be measured using a numerical pain scale (NPS). Subjects will be asked to indicate the level of pain with 0 being no pain and 10 being the worst imaginable pain. Higher scores indicate higher intensities of pain. Participants will report intensity of pain at the week 6 and 3 month time points through a telephone call.
Outcome measures
| Measure |
Ropivacaine 0.1%
n=17 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Ropivacaine 0.2%
n=19 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Normal Saline
n=17 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
|---|---|---|---|
|
Change in Intensity of Pain: Numerical Pain Scale (NPS) From Baseline
Change at 3 months post intervention
|
0 units on a scale
Interval 0.0 to 3.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.75
|
|
Change in Intensity of Pain: Numerical Pain Scale (NPS) From Baseline
Change at 6 weeks post intervention
|
3 units on a scale
Interval 0.0 to 5.0
|
2 units on a scale
Interval 0.0 to 4.0
|
5 units on a scale
Interval 2.5 to 6.5
|
PRIMARY outcome
Timeframe: 24 hours post-intervention, 48 hrs, and 72hr post-intervention.Population: The differences in the number of participants reflect patients who were discharged earlier than 72 hours and patients whose assessments could not be completed because they were not available (out of the room, etc). All 0 values are real reports of "no pain", which was the median score for Outcome 3. None of them represent missing values or NA.
Incisional pain will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with "no pain" at the bottom and "worst imaginable pain" at the top. Pain scores range from 0-100, so the change in pain score (post- minus pre-) can theoretically range from -100 to 100. A negative score indicates an improvement in pain. Higher scores indicate higher intensities of pain. Participants will report intensity of pain 2hrs post intervention, 6hr, 12hr, 24hr, 48hr, and 72hr post-intervention.
Outcome measures
| Measure |
Ropivacaine 0.1%
n=20 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Ropivacaine 0.2%
n=19 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Normal Saline
n=20 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
|---|---|---|---|
|
Change in Intensity of Pain: VAPS From Baseline
Change in score at 24 hours post intervention
|
0 units on a scale
Interval 0.0 to 5.75
|
0 units on a scale
Interval 0.0 to 13.0
|
0 units on a scale
Interval 0.0 to 44.5
|
|
Change in Intensity of Pain: VAPS From Baseline
Change in score at 48 hours post intervention
|
0 units on a scale
Interval 0.0 to 11.25
|
0 units on a scale
Interval 0.0 to 13.5
|
0 units on a scale
Interval 0.0 to 12.28
|
|
Change in Intensity of Pain: VAPS From Baseline
Change in score at 72 hours post intervention
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: 2 hours post-intervention, 6 hours, 12 hours, 24 hours, 72 hours, 6 weeks, 3 months post-interventionPopulation: The differences in number of participants reflect patients who were discharged earlier than 72 hours and patients whose assessments could not be completed because they were not available (out of the room, etc. )
Pain with movement will be assessed using the self-report mini-McGill pain questionnaire, consisting of the first 15 questions of the McGill questionnaire, scores 0-3 points for each. It can theoretically range from 0 to 45, with 45 correlating with worse pain.
Outcome measures
| Measure |
Ropivacaine 0.1%
n=20 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Ropivacaine 0.2%
n=19 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Normal Saline
n=20 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
|---|---|---|---|
|
Change in McGill Pain Questionnaire Score From Baseline
2 hrs post Baseline
|
1.5 score on a scale
Interval 0.0 to 4.0
|
2 score on a scale
Interval 0.0 to 3.5
|
2 score on a scale
Interval 1.0 to 3.5
|
|
Change in McGill Pain Questionnaire Score From Baseline
6 hrs post Baseline
|
2 score on a scale
Interval 1.0 to 4.5
|
2 score on a scale
Interval 1.0 to 2.5
|
2 score on a scale
Interval 0.0 to 4.25
|
|
Change in McGill Pain Questionnaire Score From Baseline
12 hrs post Baseline
|
1 score on a scale
Interval 0.0 to 3.0
|
1 score on a scale
Interval 0.0 to 2.0
|
2 score on a scale
Interval 1.0 to 3.5
|
|
Change in McGill Pain Questionnaire Score From Baseline
24 hrs post Baseline
|
1.5 score on a scale
Interval 1.0 to 5.25
|
3 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
|
Change in McGill Pain Questionnaire Score From Baseline
48 hrs post Baseline
|
2.5 score on a scale
Interval 1.0 to 4.25
|
3 score on a scale
Interval 0.0 to 6.0
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Change in McGill Pain Questionnaire Score From Baseline
72 hrs post Baseline
|
2 score on a scale
Interval 1.0 to 3.0
|
3 score on a scale
Interval 0.0 to 4.5
|
1 score on a scale
Interval 0.0 to 2.5
|
|
Change in McGill Pain Questionnaire Score From Baseline
6 weeks post Baseline
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.5
|
0 score on a scale
Interval 0.0 to 1.0
|
|
Change in McGill Pain Questionnaire Score From Baseline
3 months post Baseline
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 1.0
|
PRIMARY outcome
Timeframe: 2 hours post-intervention, 6 hours, 12 hours, 24 hours, 48 hous, 72 hours post baselinePopulation: The differences in number of participants reflect patients who were discharged earlier than 72 hours and patients whose assessments could not be completed because they were not available (out of the room, etc. )
The intensity of pain at rest will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with "no pain" at the bottom and "worst imaginable pain" at the top. Higher scores indicate higher intensities of pain.
Outcome measures
| Measure |
Ropivacaine 0.1%
n=20 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Ropivacaine 0.2%
n=19 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Normal Saline
n=20 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
|---|---|---|---|
|
Change in Pain Scores at Rest From Baseline
Change in score at 2-hours post baseline
|
5 score on a scale
Interval 0.0 to 23.5
|
0 score on a scale
Interval -4.5 to 9.0
|
7 score on a scale
Interval 0.0 to 27.75
|
|
Change in Pain Scores at Rest From Baseline
Change in score at 6-hours post baseline
|
3 score on a scale
Interval 0.0 to 17.0
|
0 score on a scale
Interval -7.0 to 4.0
|
5.5 score on a scale
Interval 0.0 to 15.5
|
|
Change in Pain Scores at Rest From Baseline
Change in score at 12-hours post baseline
|
5 score on a scale
Interval 0.0 to 19.25
|
0 score on a scale
Interval -7.5 to 3.5
|
1.5 score on a scale
Interval 0.0 to 12.5
|
|
Change in Pain Scores at Rest From Baseline
Change in score at 24-hours post baseline
|
8 score on a scale
Interval 0.0 to 32.75
|
5.5 score on a scale
Interval -0.75 to 16.75
|
4.5 score on a scale
Interval -3.25 to 17.75
|
|
Change in Pain Scores at Rest From Baseline
Change in score at 48-hours post baseline
|
4.5 score on a scale
Interval 0.0 to 15.75
|
3 score on a scale
Interval -4.0 to 13.5
|
2.5 score on a scale
Interval -5.5 to 22.5
|
|
Change in Pain Scores at Rest From Baseline
Change in score at 72-hours post baseline
|
0 score on a scale
Interval 0.0 to 4.0
|
0 score on a scale
Interval 0.0 to 7.0
|
2 score on a scale
Interval -6.25 to 13.5
|
SECONDARY outcome
Timeframe: Baseline (At zero time, the time of the first dosing using the On-Q catheter), 72 hours post-operativelyThe time to dosing with the first rescue medications like, non-steroidal anti-inflammatory drugs and morphine, for breakthrough pain will be noted. A shorter time to dosing indicates an increased intensity of pain. It will be recorded in hours post intervention.
Outcome measures
| Measure |
Ropivacaine 0.1%
n=20 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Ropivacaine 0.2%
n=19 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Normal Saline
n=19 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
|---|---|---|---|
|
Change in Time From Baseline to First Dose of Rescue Medications
|
9.05 Hours
Interval 1.38 to 12.94
|
3.50 Hours
Interval 1.05 to 9.75
|
2 Hours
Interval 1.38 to 10.6
|
SECONDARY outcome
Timeframe: In the post-anesthesia care unit (up to 2 hours post-operatively), 72 hours post-operativelyPopulation: Data was not obtained/recorded by nurses during shift and some patients were not available (out of the room, etc).
Breastfeeding success will be measured using LATCH scores. The LATCH system assigns a numerical score, 0, 1, or 2, to five key components of breastfeeding: "L" is for how well the infant latches onto the breast, "A" is for the amount of audible swallowing noted, "T" is for the mother's nipple type, "C" is for the mother's level of comfort and "H" is for the amount of help the mother needs to hold her infant to the breast. The theoretical range of the Latch score is 0 to 10. Higher scores indicate higher success with breastfeeding.
Outcome measures
| Measure |
Ropivacaine 0.1%
n=7 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Ropivacaine 0.2%
n=6 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Normal Saline
n=7 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
|---|---|---|---|
|
Breastfeeding Success
2 hours post intervention
|
10 score on a scale
Interval 8.75 to 10.0
|
6.5 score on a scale
Interval 5.0 to 7.25
|
6.5 score on a scale
Interval 6.25 to 6.75
|
|
Breastfeeding Success
72 hours post intervention
|
10 score on a scale
Interval 8.75 to 10.0
|
10 score on a scale
Interval 9.25 to 10.0
|
10 score on a scale
Interval 9.25 to 10.0
|
SECONDARY outcome
Timeframe: 24 hours, 48 hours, 72 hours post interventionThe cesarean section incision and the catheter insertion site will be evaluated. Any catheter or infiltrate-related issues like wound infection and seroma formation will be noted. It will be reported as number of issues. Wounds will be assessed for infection or dehiscence. Clean wound lines with no evidence of infection indicate better healing.
Outcome measures
| Measure |
Ropivacaine 0.1%
n=20 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Ropivacaine 0.2%
n=19 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Normal Saline
n=20 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
|---|---|---|---|
|
Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention
24 hours post intervention
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention
48 hours post intervention
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention
72 hours post intervention
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 weeks postintervention, 3 months postinterventionAt the 6 week and 3-month follow-up phone calls the participant will be asked about the presence of wound dysesthesia (numbness, tingling, burning, pricking, allodynia, or hyperesthesia), occurrence of infection, dehiscence, and keloid formation.
Outcome measures
| Measure |
Ropivacaine 0.1%
n=20 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Ropivacaine 0.2%
n=19 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Normal Saline
n=20 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
|---|---|---|---|
|
Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention
3 Months - Infection
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention
3 Months- Dehiscence
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention
3 Months- Keloid Formation
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention
6 Weeks- Wound Dysesthesia
|
2 Participants
|
2 Participants
|
6 Participants
|
|
Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention
6 Weeks- Infection
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention
6 Weeks- Dehiscence
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention
6 Weeks- Keloid Formation
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention
3 Months- Wound Dysesthesia
|
1 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: At the time of hospital discharge (average of 3 days)A cost analysis will occur for the inpatient stay. Costs to be assessed include cost for preparation of the drugs and devices, monitoring/supervision costs based on nursing and physician interventions and cost of days spent in the hospital.
Outcome measures
| Measure |
Ropivacaine 0.1%
n=20 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Ropivacaine 0.2%
n=19 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Normal Saline
n=20 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
|---|---|---|---|
|
Cost Analysis
|
27.9 Dollars
Standard Deviation 16.6
|
26.8 Dollars
Standard Deviation 18.8
|
31.6 Dollars
Standard Deviation 19.8
|
SECONDARY outcome
Timeframe: 72 hours post-operativelyPatient satisfaction will be assessed by using the visual analog scale (VAS). The visual analog scale (VAS) for satisfaction is a horizontal line 100mm long. At the beginning and the end, there are two descriptors representing extremes of satisfaction. The subjects will be asked to rate their satisfaction by making a vertical mark on the 100mm line, where, 0= least satisfied and 100=most satisfied. Higher scores indicate higher levels of satisfaction.
Outcome measures
| Measure |
Ropivacaine 0.1%
n=19 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Ropivacaine 0.2%
n=17 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Normal Saline
n=20 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
|---|---|---|---|
|
Patient Satisfaction at 72 Hours Post Intervention
|
60 units on a scale
Standard Deviation 40.15
|
61.53 units on a scale
Standard Deviation 39.00
|
48.3 units on a scale
Standard Deviation 35.43
|
SECONDARY outcome
Timeframe: 24 post-operatively, 72 hours post-operativelyThe total dose of non-steroidal anti-inflammatory drugs (NSAIDs) in mg will be recorded for each of the first three post-operative days and after discharge as indicated, along with a cumulative total. Higher doses of NSAIDs usage indicate higher intensities of pain.
Outcome measures
| Measure |
Ropivacaine 0.1%
n=20 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Ropivacaine 0.2%
n=19 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Normal Saline
n=19 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
|---|---|---|---|
|
Dosing Amount of Non-steroidal Anti-inflammatory Drugs
24 hours post intervention
|
80 mg
Standard Deviation 246
|
211 mg
Standard Deviation 645
|
379 mg
Standard Deviation 899
|
|
Dosing Amount of Non-steroidal Anti-inflammatory Drugs
72 hours post intervention
|
2040 mg
Standard Deviation 799
|
1726 mg
Standard Deviation 1075
|
1095 mg
Standard Deviation 1228
|
SECONDARY outcome
Timeframe: 24 post-operatively, 72 hours post-operativelyThe amount of opioid use will be quantified in terms of morphine equivalents given in mg both by post -operative day and with a cumulative total. Higher amounts of opioid use indicates higher degrees of pain.
Outcome measures
| Measure |
Ropivacaine 0.1%
n=20 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Ropivacaine 0.2%
n=19 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
Normal Saline
n=20 Participants
Subjects undergoing cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.
|
|---|---|---|---|
|
Amount of Opioid Use
24 hours post intervention
|
0.35 mg
Standard Deviation 1.77
|
6.45 mg
Standard Deviation 27.50
|
1.65 mg
Standard Deviation 5.28
|
|
Amount of Opioid Use
72 hours post intervention
|
24.98 mg
Standard Deviation 37.81
|
54.28 mg
Standard Deviation 164.3
|
31.25 mg
Standard Deviation 41.33
|
Adverse Events
Ropivacaine 0.1%
Ropivacaine 0.2%
Normal Saline
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