Trial Outcomes & Findings for A Randomized Control Trial Comparing Analgesic Benefits of Ultrasound-guided Single vs Continuous Quadratus Lumborum Blocks (QLB)vs Intrathecal Morphine(ITM) for Post Cesarean Section Pain (NCT NCT04368364)
NCT ID: NCT04368364
Last Updated: 2022-05-16
Results Overview
Total narcotic consumption in morphine equivalents (in milligrams) for the first 72 hours after surgery was calculated.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
3 participants
Primary outcome timeframe
upto 72 hours post surgery
Results posted on
2022-05-16
Participant Flow
Participant milestones
| Measure |
Group 1 (Control Group)
Intrathecal morphine sulfate (ITM): Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
|
Group 2(Bupivacaine Hydrochloride Group)
Bupivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
|
Group 3 (Ropivacaine Hydrochloride Group)
ropivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1 (Control Group)
n=1 Participants
Intrathecal morphine sulfate (ITM): Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
|
Group 2(Bupivacaine Hydrochloride Group)
n=1 Participants
Bupivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
|
Group 3 (Ropivacaine Hydrochloride Group)
n=1 Participants
ropivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26 years
STANDARD_DEVIATION 0 • n=1 Participants
|
33 years
STANDARD_DEVIATION 0 • n=1 Participants
|
36 years
STANDARD_DEVIATION 0 • n=1 Participants
|
31.66 years
STANDARD_DEVIATION 5.13 • n=3 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
3 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
1 participants
n=1 Participants
|
1 participants
n=1 Participants
|
1 participants
n=1 Participants
|
3 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: upto 72 hours post surgeryTotal narcotic consumption in morphine equivalents (in milligrams) for the first 72 hours after surgery was calculated.
Outcome measures
| Measure |
Group 1 (Control Group)
n=1 Participants
Intrathecal morphine sulfate (ITM): Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
|
Group 2(Bupivacaine Hydrochloride Group)
n=1 Participants
Bupivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
|
Group 3 (Ropivacaine Hydrochloride Group)
n=1 Participants
ropivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
|
|---|---|---|---|
|
Total Narcotic Consumption in Morphine Equivalents (in Milligrams)
|
25 milligrams
Standard Deviation 0
|
12.5 milligrams
Standard Deviation 0
|
0 milligrams
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 12,24,48 hours post surgeryPopulation: Data were not collected at 12 hours post surgery.
Total narcotic consumption in morphine equivalents (in milligrams) for 12, 24 and 48 hours after surgery was calculated.
Outcome measures
| Measure |
Group 1 (Control Group)
n=1 Participants
Intrathecal morphine sulfate (ITM): Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
|
Group 2(Bupivacaine Hydrochloride Group)
n=1 Participants
Bupivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
|
Group 3 (Ropivacaine Hydrochloride Group)
n=1 Participants
ropivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
|
|---|---|---|---|
|
Total Narcotic Consumption in Morphine Equivalents (in Milligrams)
24 hours
|
12.5 milligrams
Standard Deviation 0
|
12.5 milligrams
Standard Deviation 0
|
0 milligrams
Standard Deviation 0
|
|
Total Narcotic Consumption in Morphine Equivalents (in Milligrams)
48 hours
|
25 milligrams
Standard Deviation 0
|
12.5 milligrams
Standard Deviation 0
|
0 milligrams
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 6, 12, 24, 48 and 72 hours post surgeryTo assess static pain scores, NPS will be recorded while the participant is supine in bed. NPS is a 11-point scale with a higher number indicating more severe pain (total score ranges from 0 to 10).
Outcome measures
| Measure |
Group 1 (Control Group)
n=1 Participants
Intrathecal morphine sulfate (ITM): Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
|
Group 2(Bupivacaine Hydrochloride Group)
n=1 Participants
Bupivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
|
Group 3 (Ropivacaine Hydrochloride Group)
n=1 Participants
ropivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
|
|---|---|---|---|
|
Static Pain as Measured by the Numerical Pain Score (NPS)
6 hours
|
0 score on a scale
Standard Deviation 0
|
2 score on a scale
Standard Deviation 0
|
1 score on a scale
Standard Deviation 0
|
|
Static Pain as Measured by the Numerical Pain Score (NPS)
12 hours
|
0 score on a scale
Standard Deviation 0
|
4 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Static Pain as Measured by the Numerical Pain Score (NPS)
24 hours
|
3.5 score on a scale
Standard Deviation 0
|
4 score on a scale
Standard Deviation 0
|
2 score on a scale
Standard Deviation 0
|
|
Static Pain as Measured by the Numerical Pain Score (NPS)
48 hours
|
2 score on a scale
Standard Deviation 0
|
2 score on a scale
Standard Deviation 0
|
2 score on a scale
Standard Deviation 0
|
|
Static Pain as Measured by the Numerical Pain Score (NPS)
72 hours
|
4 score on a scale
Standard Deviation 0
|
1 score on a scale
Standard Deviation 0
|
1 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 24, 48 and 72 hours post surgeryThis numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect. Total score ranges from 0 to 10.
Outcome measures
| Measure |
Group 1 (Control Group)
n=1 Participants
Intrathecal morphine sulfate (ITM): Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
|
Group 2(Bupivacaine Hydrochloride Group)
n=1 Participants
Bupivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
|
Group 3 (Ropivacaine Hydrochloride Group)
n=1 Participants
ropivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
|
|---|---|---|---|
|
Severity of Pruritus as Assessed by a Scale
24 hours
|
6 score on a scale
Standard Deviation 0
|
2 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Severity of Pruritus as Assessed by a Scale
48 hours
|
0 score on a scale
Standard Deviation 0
|
1 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Severity of Pruritus as Assessed by a Scale
72 hours
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 24, 48 and 72 hours post surgeryThis numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect. Total score ranges from 0 to 10.
Outcome measures
| Measure |
Group 1 (Control Group)
n=1 Participants
Intrathecal morphine sulfate (ITM): Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
|
Group 2(Bupivacaine Hydrochloride Group)
n=1 Participants
Bupivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
|
Group 3 (Ropivacaine Hydrochloride Group)
n=1 Participants
ropivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
|
|---|---|---|---|
|
Severity of Nausea as Assessed by a Scale
24 hours
|
0 score on a scale
Standard Deviation 0
|
2 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Severity of Nausea as Assessed by a Scale
48 houts
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Severity of Nausea as Assessed by a Scale
72 hours
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 24, 48 and 72 hours post surgeryThis numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect. Total score ranges from 0 to 10.
Outcome measures
| Measure |
Group 1 (Control Group)
n=1 Participants
Intrathecal morphine sulfate (ITM): Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
|
Group 2(Bupivacaine Hydrochloride Group)
n=1 Participants
Bupivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
|
Group 3 (Ropivacaine Hydrochloride Group)
n=1 Participants
ropivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
|
|---|---|---|---|
|
Severity of Vomiting as Assessed by a Scale
48 hours
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Severity of Vomiting as Assessed by a Scale
24 hours
|
0 score on a scale
Standard Deviation 0
|
3 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Severity of Vomiting as Assessed by a Scale
72 hours
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 24, 48 and 72 hours post surgeryThis numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect. Total score ranges from 0 to 10.
Outcome measures
| Measure |
Group 1 (Control Group)
n=1 Participants
Intrathecal morphine sulfate (ITM): Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
|
Group 2(Bupivacaine Hydrochloride Group)
n=1 Participants
Bupivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
|
Group 3 (Ropivacaine Hydrochloride Group)
n=1 Participants
ropivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
|
|---|---|---|---|
|
Severity of Sedation as Assessed by a Scale
24 hours
|
0 score on a scale
Standard Deviation 0
|
3 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Severity of Sedation as Assessed by a Scale
48 hours
|
0 score on a scale
Standard Deviation 0
|
1 score on a scale
Standard Deviation 0
|
1 score on a scale
Standard Deviation 0
|
|
Severity of Sedation as Assessed by a Scale
72 hours
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 24 hours post surgeryPatient reported a score for each of 4 different aspects of satisfaction: their quality of sleep, ability to ambulate, ability to breast or formula feed, and ability to feed and take care of newborn. Each of the 4 aspects of satisfaction were rated on a 5-point Likert scale as follows: Extremely satisfied (5), Very satisfied (4), Moderately satisfied (3), Slightly satisfied (2), Not satisfied (1).
Outcome measures
| Measure |
Group 1 (Control Group)
n=1 Participants
Intrathecal morphine sulfate (ITM): Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
|
Group 2(Bupivacaine Hydrochloride Group)
n=1 Participants
Bupivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
|
Group 3 (Ropivacaine Hydrochloride Group)
n=1 Participants
ropivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
|
|---|---|---|---|
|
Patient Satisfaction as Assessed by Likert Scale
quality of sleep
|
4 score on a scale
Standard Deviation 0
|
3 score on a scale
Standard Deviation 0
|
4 score on a scale
Standard Deviation 0
|
|
Patient Satisfaction as Assessed by Likert Scale
ability to ambulate
|
2 score on a scale
Standard Deviation 0
|
3 score on a scale
Standard Deviation 0
|
5 score on a scale
Standard Deviation 0
|
|
Patient Satisfaction as Assessed by Likert Scale
ability to breast or formula feed
|
4 score on a scale
Standard Deviation 0
|
3 score on a scale
Standard Deviation 0
|
5 score on a scale
Standard Deviation 0
|
|
Patient Satisfaction as Assessed by Likert Scale
ability to feed and take care of newborn at 24 hours
|
3 score on a scale
Standard Deviation 0
|
3 score on a scale
Standard Deviation 0
|
5 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 6, 12, 24, 48 and 72 hours post surgeryTo assess dynamic pain scores, the participant be asked to sit up in bed from supine to sitting, and the NPS will then be recorded. If the participant is ambulating, the dynamic pain score during ambulation (rather during sitting) will be assessed. NPS is a 11-point scale with a higher number indicating more severe pain (total score ranges from 0 to 10).
Outcome measures
| Measure |
Group 1 (Control Group)
n=1 Participants
Intrathecal morphine sulfate (ITM): Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
|
Group 2(Bupivacaine Hydrochloride Group)
n=1 Participants
Bupivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
|
Group 3 (Ropivacaine Hydrochloride Group)
n=1 Participants
ropivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
|
|---|---|---|---|
|
Dynamic Pain as Measured by the Numerical Pain Score (NPS)
24 hours
|
8 score on a scale
Standard Deviation 0
|
6 score on a scale
Standard Deviation 0
|
2 score on a scale
Standard Deviation 0
|
|
Dynamic Pain as Measured by the Numerical Pain Score (NPS)
48 hours
|
4 score on a scale
Standard Deviation 0
|
2 score on a scale
Standard Deviation 0
|
2 score on a scale
Standard Deviation 0
|
|
Dynamic Pain as Measured by the Numerical Pain Score (NPS)
72 hours
|
7 score on a scale
Standard Deviation 0
|
1 score on a scale
Standard Deviation 0
|
1 score on a scale
Standard Deviation 0
|
|
Dynamic Pain as Measured by the Numerical Pain Score (NPS)
6 hours
|
0 score on a scale
Standard Deviation 0
|
3 score on a scale
Standard Deviation 0
|
1 score on a scale
Standard Deviation 0
|
|
Dynamic Pain as Measured by the Numerical Pain Score (NPS)
12 hours
|
6 score on a scale
Standard Deviation 0
|
6 score on a scale
Standard Deviation 0
|
1 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 48 hours post surgeryPatient reported a score for each of 4 different aspects of satisfaction: their quality of sleep, ability to ambulate, ability to breast or formula feed, and ability to feed and take care of newborn. Each of the 4 aspects of satisfaction were rated on a 5-point Likert scale as follows: Extremely satisfied (5), Very satisfied (4), Moderately satisfied (3), Slightly satisfied (2), Not satisfied (1).
Outcome measures
| Measure |
Group 1 (Control Group)
n=1 Participants
Intrathecal morphine sulfate (ITM): Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
|
Group 2(Bupivacaine Hydrochloride Group)
n=1 Participants
Bupivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
|
Group 3 (Ropivacaine Hydrochloride Group)
n=1 Participants
ropivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
|
|---|---|---|---|
|
Patient Satisfaction as Assessed by Likert Scale
ability to ambulate
|
4 score on a scale
Standard Deviation 0
|
4 score on a scale
Standard Deviation 0
|
5 score on a scale
Standard Deviation 0
|
|
Patient Satisfaction as Assessed by Likert Scale
ability to breast or formula feed
|
4 score on a scale
Standard Deviation 0
|
3 score on a scale
Standard Deviation 0
|
5 score on a scale
Standard Deviation 0
|
|
Patient Satisfaction as Assessed by Likert Scale
quality of sleep
|
4 score on a scale
Standard Deviation 0
|
4 score on a scale
Standard Deviation 0
|
5 score on a scale
Standard Deviation 0
|
|
Patient Satisfaction as Assessed by Likert Scale
ability to feed and take care of newborn at 24 hours
|
4 score on a scale
Standard Deviation 0
|
4 score on a scale
Standard Deviation 0
|
4 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 72 hours post surgeryPatient reported a score for each of 4 different aspects of satisfaction: their quality of sleep, ability to ambulate, ability to breast or formula feed, and ability to feed and take care of newborn. Each of the 4 aspects of satisfaction were rated on a 5-point Likert scale as follows: Extremely satisfied (5), Very satisfied (4), Moderately satisfied (3), Slightly satisfied (2), Not satisfied (1).
Outcome measures
| Measure |
Group 1 (Control Group)
n=1 Participants
Intrathecal morphine sulfate (ITM): Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
|
Group 2(Bupivacaine Hydrochloride Group)
n=1 Participants
Bupivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
|
Group 3 (Ropivacaine Hydrochloride Group)
n=1 Participants
ropivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
|
|---|---|---|---|
|
Patient Satisfaction as Assessed by Likert Scale
ability to breast or formula feed
|
3 score on a scale
Standard Deviation 0
|
4 score on a scale
Standard Deviation 0
|
5 score on a scale
Standard Deviation 0
|
|
Patient Satisfaction as Assessed by Likert Scale
ability to feed and take care of newborn
|
3 score on a scale
Standard Deviation 0
|
4 score on a scale
Standard Deviation 0
|
5 score on a scale
Standard Deviation 0
|
|
Patient Satisfaction as Assessed by Likert Scale
quality of sleep
|
3 score on a scale
Standard Deviation 0
|
5 score on a scale
Standard Deviation 0
|
5 score on a scale
Standard Deviation 0
|
|
Patient Satisfaction as Assessed by Likert Scale
ability to ambulate
|
2 score on a scale
Standard Deviation 0
|
4 score on a scale
Standard Deviation 0
|
5 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 72 hours post surgeryOutcome measures
| Measure |
Group 1 (Control Group)
n=1 Participants
Intrathecal morphine sulfate (ITM): Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
|
Group 2(Bupivacaine Hydrochloride Group)
n=1 Participants
Bupivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
|
Group 3 (Ropivacaine Hydrochloride Group)
n=1 Participants
ropivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
|
|---|---|---|---|
|
Time to First Analgesic Request
|
414 minutes
Standard Deviation 0
|
1043 minutes
Standard Deviation 0
|
0 minutes
Standard Deviation 0
|
Adverse Events
Group 1 (Control Group)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 2(Bupivacaine Hydrochloride Group)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 3 (Ropivacaine Hydrochloride Group)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1 (Control Group)
n=1 participants at risk
Intrathecal morphine sulfate (ITM): Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
|
Group 2(Bupivacaine Hydrochloride Group)
n=1 participants at risk
Bupivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
|
Group 3 (Ropivacaine Hydrochloride Group)
n=1 participants at risk
ropivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
100.0%
1/1 • 72 hours
|
100.0%
1/1 • 72 hours
|
0.00%
0/1 • 72 hours
|
|
General disorders
Nausea
|
0.00%
0/1 • 72 hours
|
100.0%
1/1 • 72 hours
|
0.00%
0/1 • 72 hours
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • 72 hours
|
100.0%
1/1 • 72 hours
|
0.00%
0/1 • 72 hours
|
|
General disorders
Sedation
|
0.00%
0/1 • 72 hours
|
100.0%
1/1 • 72 hours
|
100.0%
1/1 • 72 hours
|
Additional Information
Sudipta Sen, MD, Assistant Professor
The University of Texas Health Science Center at Houston
Phone: 713-500-6200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place