Trial Outcomes & Findings for ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain (NCT NCT03261193)
NCT ID: NCT03261193
Last Updated: 2024-05-06
Results Overview
Post-operative pain accompanied with patient movement will be measured using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
21 participants
Primary outcome timeframe
24 hours after surgical procedure (cesarean delivery)
Results posted on
2024-05-06
Participant Flow
Participant milestones
| Measure |
ITM + Sham QLB
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain
Baseline characteristics by cohort
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
31.80 Years
STANDARD_DEVIATION 4.16 • n=5 Participants
|
33.35 Years
STANDARD_DEVIATION 5.17 • n=7 Participants
|
32.55 Years
STANDARD_DEVIATION 4.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, Caucasian (not Hispanic or Latino)
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American (not Hispanic or Latino)
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian (not Hispanic or Latino)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian / Alaskan Native (not Hispanic or Latino)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Declined to answer
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Gravidity
|
2.93 Number of pregnancies
STANDARD_DEVIATION 1.67 • n=5 Participants
|
2.64 Number of pregnancies
STANDARD_DEVIATION 1.08 • n=7 Participants
|
2.79 Number of pregnancies
STANDARD_DEVIATION 1.40 • n=5 Participants
|
|
Parity
|
1.27 Number of births
STANDARD_DEVIATION 0.80 • n=5 Participants
|
0.93 Number of births
STANDARD_DEVIATION 0.47 • n=7 Participants
|
1.10 Number of births
STANDARD_DEVIATION 0.67 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours after surgical procedure (cesarean delivery)Post-operative pain accompanied with patient movement will be measured using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Visual Analogue Scale (VAS) Pain Score With Movement
|
4.85 Units on a scale
Standard Deviation 2.23
|
3.14 Units on a scale
Standard Deviation 1.83
|
SECONDARY outcome
Timeframe: 24-hours post-operativelyPopulation: This data was not collected during the duration of this study.
Limited breastfeeding resulting from pain or opioid side effects
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 hour after interventionPopulation: Data was not collected at the specified timepoint for this outcome.
VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From post-operative until the patient is either withdrawn from the study or requests analgesic medication up until 72 hoursTime to first opioid dose (measured in hours)
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
First Request for Pain Medication
|
17.30 Hours
Standard Deviation 14.90
|
17.37 Hours
Standard Deviation 14.29
|
SECONDARY outcome
Timeframe: 24-hours post-operativePresence or absence will be noted. Will be measured via Ramsay Sedation Score which ranges on a scale of 1 to 6 as follows: 1-patient is anxious, agitated, or restless. 2-patient is co-operative and oriented. 3-patient responds to commands only. 4-patient exhibits brisk response to light stimuli or loud auditory stimuli. 5-patient exhibits sluggish response to light or auditory stimuli. 6-patient exhibits no response.
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Sedation
Score 1
|
0 Participants
|
0 Participants
|
|
Sedation
Score 2
|
10 Participants
|
11 Participants
|
|
Sedation
Score 3
|
0 Participants
|
0 Participants
|
|
Sedation
Score 4
|
0 Participants
|
0 Participants
|
|
Sedation
Score 5
|
0 Participants
|
0 Participants
|
|
Sedation
Score 6
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4-hours post-operativePresence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Pruritis
Group 0
|
4 Participants
|
3 Participants
|
|
Pruritis
Group 1
|
2 Participants
|
5 Participants
|
|
Pruritis
Group 2
|
3 Participants
|
2 Participants
|
|
Pruritis
Group 3
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 4-hours post-operativePresence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Nausea/Vomiting
Score 0
|
6 Participants
|
10 Participants
|
|
Nausea/Vomiting
Score 1
|
2 Participants
|
0 Participants
|
|
Nausea/Vomiting
Score 2
|
2 Participants
|
1 Participants
|
|
Nausea/Vomiting
Score 3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4-hours post-operativeWill be measured in mmHG per standard of care and documented by study staff.
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Systolic Blood Pressure
|
113.69 mmHg
Standard Deviation 12.94
|
116.21 mmHg
Standard Deviation 12.05
|
SECONDARY outcome
Timeframe: 4-hours post-operativeWill be measured in rate/min per standard of care and documented by study staff
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Respiratory Rate
|
16.54 Breaths/minute
Standard Deviation 1.76
|
16.07 Breaths/minute
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: 4-hours post-operativeWill be measured in % per standard of care and documented by study staff
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Oxygen Saturation
|
96.6 percentage of SpO2
Standard Deviation 2.07
|
98.4 percentage of SpO2
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: 4 hours after interventionVAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Visual Analogue Scale (VAS) Pain Score at Rest
|
3.5 units on a scale
Standard Deviation 2.77
|
1.36 units on a scale
Standard Deviation 1.65
|
SECONDARY outcome
Timeframe: 24 hours after interventionVAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Visual Analogue Scale (VAS) Pain Score at Rest
|
3.14 units on a scale
Standard Deviation 1.83
|
2.38 units on a scale
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: 48 hours after interventionVAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Visual Analogue Scale (VAS) Pain Score at Rest
|
3.73 units on a scale
Standard Deviation 2.57
|
3.4 units on a scale
Standard Deviation 2.63
|
SECONDARY outcome
Timeframe: 24-hours post-operativePresence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Pruritis
Group 0
|
5 Participants
|
5 Participants
|
|
Pruritis
Group 1
|
2 Participants
|
3 Participants
|
|
Pruritis
Group 2
|
2 Participants
|
2 Participants
|
|
Pruritis
Group 3
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 48-hours post-operativePresence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Pruritis
Group 0
|
8 Participants
|
10 Participants
|
|
Pruritis
Group 1
|
1 Participants
|
0 Participants
|
|
Pruritis
Group 2
|
1 Participants
|
1 Participants
|
|
Pruritis
Group 3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24-hours post-operativePresence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Nausea/Vomiting
Score 0
|
9 Participants
|
10 Participants
|
|
Nausea/Vomiting
Score 1
|
1 Participants
|
0 Participants
|
|
Nausea/Vomiting
Score 2
|
0 Participants
|
1 Participants
|
|
Nausea/Vomiting
Score 3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 48-hours post-operativePresence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Nausea/Vomiting
Score 0
|
8 Participants
|
11 Participants
|
|
Nausea/Vomiting
Score 1
|
2 Participants
|
0 Participants
|
|
Nausea/Vomiting
Score 2
|
0 Participants
|
0 Participants
|
|
Nausea/Vomiting
Score 3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4-hours post-operativeStandard heart rate obtained
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Heart Rate
|
82.62 Heartbeats/minute
Standard Deviation 10.63
|
78.86 Heartbeats/minute
Standard Deviation 15.94
|
SECONDARY outcome
Timeframe: 24-hours post-operativeStandard heart rate obtained
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Heart Rate
|
86.86 Heartbeats/minute
Standard Deviation 10.24
|
91.33 Heartbeats/minute
Standard Deviation 6.15
|
SECONDARY outcome
Timeframe: 48-hours post-operativeStandard heart rate obtained
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Heart Rate
|
87.00 Heartbeats/minute
Standard Deviation 7.55
|
86.50 Heartbeats/minute
Standard Deviation 3.54
|
SECONDARY outcome
Timeframe: 24-hours post-operativeWill be measured in mmHG per standard of care and documented by study staff.
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Systolic Blood Pressure
|
109.29 mmHg
Standard Deviation 9.41
|
111.00 mmHg
Standard Deviation 11.40
|
SECONDARY outcome
Timeframe: 48-hours post-operativeWill be measured in mmHG per standard of care and documented by study staff.
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Systolic Blood Pressure
|
117.6 mmHg
Standard Deviation 13.15
|
124.00 mmHg
Standard Deviation 5.66
|
SECONDARY outcome
Timeframe: 4-hours post-operativeWill be measured in mmHG per standard of care and documented by study staff.
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Diastolic Blood Pressure
|
71.15 mmHg
Standard Deviation 9.21
|
70.36 mmHg
Standard Deviation 2.29
|
SECONDARY outcome
Timeframe: 24-hours post-operativeWill be measured in mmHG per standard of care and documented by study staff.
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Diastolic Blood Pressure
|
68.00 mmHg
Standard Deviation 7.96
|
70.67 mmHg
Standard Deviation 8.96
|
SECONDARY outcome
Timeframe: 48-hours post-operativeWill be measured in mmHG per standard of care and documented by study staff.
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Diastolic Blood Pressure
|
75.80 mmHg
Standard Deviation 9.09
|
76.50 mmHg
Standard Deviation 7.78
|
SECONDARY outcome
Timeframe: 24-hours post-operativeWill be measured in rate/min per standard of care and documented by study staff
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Respiratory Rate
|
16.29 Breaths/minute
Standard Deviation 2.93
|
16.67 Breaths/minute
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: 48-hours post-operativeWill be measured in rate/min per standard of care and documented by study staff
Outcome measures
| Measure |
ITM + Sham QLB
n=10 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline
|
ITM + Bupivacaine QLB
n=11 Participants
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia
|
|---|---|---|
|
Respiratory Rate
|
16.40 Breaths/minute
Standard Deviation 2.19
|
18.00 Breaths/minute
Standard Deviation 0.00
|
Adverse Events
ITM + Sham QLB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ITM + Bupivacaine QLB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place