Trial Outcomes & Findings for Efficacy Of Quadratus Lumborum II Block For Laparoscopic Sleeve Gastrectomy (NCT NCT04073056)
NCT ID: NCT04073056
Last Updated: 2023-01-05
Results Overview
The amount of opioid consumption (in mg IV morphine equivalents) during and after procedure (100mcg fentanyl= 10mg morphine) (1.5mg dilaudid=10mg morphine)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2
Results posted on
2023-01-05
Participant Flow
Participant milestones
| Measure |
Quadratus Lumborum II Group
The QL 2 group received 15 mL bupivacaine 0.25% on both sides for a total of 30 mL once the surgery is done but prior to extubation under ultrasound guidance.
Bupivacaine: Bupivacaine Hcl 0.25% Inj
|
Conventional Therapy
Conventional therapy consists of the injection of 30 mL of bupivacaine 0.25% directly into the incision sites by the surgeon at the end of the procedure.
Bupivacaine: Bupivacaine Hcl 0.25% Inj
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
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 |
Conventional Therapy
n=20 Participants
Conventional therapy consists of the injection of 30 mL of bupivacaine 0.25% directly into the incision sites by the surgeon at the end of the procedure.
Bupivacaine: Bupivacaine Hcl 0.25% Inj
|
Quadratus Lumborum II Group
n=20 Participants
The QL 2 group received 15 mL bupivacaine 0.25% on both sides for a total of 30 mL once the surgery is done but prior to extubation under ultrasound guidance.
Bupivacaine: Bupivacaine Hcl 0.25% Inj
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.0 years
STANDARD_DEVIATION 11.3 • n=20 Participants
|
37.4 years
STANDARD_DEVIATION 9.84 • n=20 Participants
|
38.2 years
STANDARD_DEVIATION 10.5 • n=40 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
33 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index (BMI)
|
42.9 kg/m2
STANDARD_DEVIATION 5.50 • n=20 Participants
|
43.3 kg/m2
STANDARD_DEVIATION 7.46 • n=20 Participants
|
43.1 kg/m2
STANDARD_DEVIATION 6.47 • n=40 Participants
|
|
Existence of preexisting pain
|
5 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Pre Non-analgesic Meds
|
12 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
25 Participants
n=40 Participants
|
|
Pre Analgesic Meds
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Recreational drug use
|
4 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Preop Systolic Blood Pressure (BP)
|
125 mmHg
STANDARD_DEVIATION 9.51 • n=20 Participants
|
127 mmHg
STANDARD_DEVIATION 14.2 • n=20 Participants
|
126 mmHg
STANDARD_DEVIATION 12.0 • n=40 Participants
|
|
Preop Diastolic BP
|
80.0 mmHg
STANDARD_DEVIATION 8.19 • n=20 Participants
|
79.5 mmHg
STANDARD_DEVIATION 8.24 • n=20 Participants
|
79.7 mmHg
STANDARD_DEVIATION 8.11 • n=40 Participants
|
|
Preop Mean Arterial Pressure (MAP)
|
90.2 mmHg
STANDARD_DEVIATION 22.4 • n=20 Participants
|
95.2 mmHg
STANDARD_DEVIATION 9.25 • n=20 Participants
|
92.7 mmHg
STANDARD_DEVIATION 17.1 • n=40 Participants
|
|
Preop Heart Rate (HR)
|
87.4 beats per minute
STANDARD_DEVIATION 12.0 • n=20 Participants
|
84.3 beats per minute
STANDARD_DEVIATION 15.7 • n=20 Participants
|
85.8 beats per minute
STANDARD_DEVIATION 13.9 • n=40 Participants
|
|
Preop Respiratory Rate (RR)
|
16.3 breaths per minute
STANDARD_DEVIATION 1.14 • n=20 Participants
|
17.9 breaths per minute
STANDARD_DEVIATION 2.66 • n=20 Participants
|
17.1 breaths per minute
STANDARD_DEVIATION 2.15 • n=40 Participants
|
|
Preop Oxygen Saturation (SpO2)
|
98.5 percent
STANDARD_DEVIATION 0.820 • n=20 Participants
|
98.0 percent
STANDARD_DEVIATION 1.34 • n=20 Participants
|
98.3 percent
STANDARD_DEVIATION 1.12 • n=40 Participants
|
PRIMARY outcome
Timeframe: Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2Population: Post Anesthesia Care Unity (PACU) hr 2 - one participant from each group was ready for discharge from the PACU prior to the 2nd hour. Postop Day (POD) 2 - two participants from each group could not be reached by phone.
The amount of opioid consumption (in mg IV morphine equivalents) during and after procedure (100mcg fentanyl= 10mg morphine) (1.5mg dilaudid=10mg morphine)
Outcome measures
| Measure |
Conventional Therapy
n=20 Participants
Conventional therapy consists of the injection of 30 mL of bupivacaine 0.25% directly into the incision sites by the surgeon at the end of the procedure.
|
Quadratus Lumborum II Group
n=20 Participants
The QL 2 group received 15 mL bupivacaine 0.25% on both sides for a total of 30 mL once the surgery is done but prior to extubation under ultrasound guidance.
|
|---|---|---|
|
The Amount of Opioid Consumption During and After Procedure
Intraop
|
26.3 mg IV morphine equivalents
Standard Deviation 12.4
|
27.1 mg IV morphine equivalents
Standard Deviation 11.9
|
|
The Amount of Opioid Consumption During and After Procedure
POQ1 - PACU hour 1
|
5.49 mg IV morphine equivalents
Standard Deviation 3.49
|
5.52 mg IV morphine equivalents
Standard Deviation 3.64
|
|
The Amount of Opioid Consumption During and After Procedure
POQ2 - PACU hour 2
|
2.80 mg IV morphine equivalents
Standard Deviation 1.66
|
1.68 mg IV morphine equivalents
Standard Deviation 2.10
|
|
The Amount of Opioid Consumption During and After Procedure
POD 0
|
4.14 mg IV morphine equivalents
Standard Deviation 5.12
|
2.53 mg IV morphine equivalents
Standard Deviation 3.16
|
|
The Amount of Opioid Consumption During and After Procedure
POD1
|
3.13 mg IV morphine equivalents
Standard Deviation 4.72
|
2.75 mg IV morphine equivalents
Standard Deviation 3.52
|
|
The Amount of Opioid Consumption During and After Procedure
POD2
|
0.938 mg IV morphine equivalents
Standard Deviation 1.46
|
0.750 mg IV morphine equivalents
Standard Deviation 1.43
|
SECONDARY outcome
Timeframe: Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2Population: PACU hr 2 - one participant from each group was ready for discharge from the PACU prior to the 2nd hour. POD 2 - two participants from each group could not be reached by phone.
Visual analogue scale - total score from 0 to 10, with higher score indicating more pain
Outcome measures
| Measure |
Conventional Therapy
n=20 Participants
Conventional therapy consists of the injection of 30 mL of bupivacaine 0.25% directly into the incision sites by the surgeon at the end of the procedure.
|
Quadratus Lumborum II Group
n=20 Participants
The QL 2 group received 15 mL bupivacaine 0.25% on both sides for a total of 30 mL once the surgery is done but prior to extubation under ultrasound guidance.
|
|---|---|---|
|
VAS Pain Scores
POQ1 - PACU hour 1
|
6.60 score on a scale
Standard Deviation 2.11
|
6.15 score on a scale
Standard Deviation 1.95
|
|
VAS Pain Scores
POQ2 - PACU hour 2
|
4.37 score on a scale
Standard Deviation 2.27
|
3.11 score on a scale
Standard Deviation 1.59
|
|
VAS Pain Scores
POD 0
|
5.85 score on a scale
Standard Deviation 2.89
|
4.80 score on a scale
Standard Deviation 2.33
|
|
VAS Pain Scores
POD1
|
6.20 score on a scale
Standard Deviation 2.71
|
4.05 score on a scale
Standard Deviation 1.96
|
|
VAS Pain Scores
POD2
|
5.00 score on a scale
Standard Deviation 2.57
|
3.28 score on a scale
Standard Deviation 1.87
|
SECONDARY outcome
Timeframe: 1 hour post opRespiratory rate in breaths per minute
Outcome measures
| Measure |
Conventional Therapy
n=20 Participants
Conventional therapy consists of the injection of 30 mL of bupivacaine 0.25% directly into the incision sites by the surgeon at the end of the procedure.
|
Quadratus Lumborum II Group
n=20 Participants
The QL 2 group received 15 mL bupivacaine 0.25% on both sides for a total of 30 mL once the surgery is done but prior to extubation under ultrasound guidance.
|
|---|---|---|
|
Respiratory Rate
|
22.5 breaths per minute
Standard Deviation 2.72
|
17.0 breaths per minute
Standard Deviation 4.80
|
SECONDARY outcome
Timeframe: 1 hour after surgeryHeart rate in beats per minute
Outcome measures
| Measure |
Conventional Therapy
n=20 Participants
Conventional therapy consists of the injection of 30 mL of bupivacaine 0.25% directly into the incision sites by the surgeon at the end of the procedure.
|
Quadratus Lumborum II Group
n=20 Participants
The QL 2 group received 15 mL bupivacaine 0.25% on both sides for a total of 30 mL once the surgery is done but prior to extubation under ultrasound guidance.
|
|---|---|---|
|
Heart Rate
|
85.3 beats per minute
Standard Deviation 14.0
|
7.3 beats per minute
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: 1 hour after surgeryBoth systolic and diastolic pressures
Outcome measures
| Measure |
Conventional Therapy
n=20 Participants
Conventional therapy consists of the injection of 30 mL of bupivacaine 0.25% directly into the incision sites by the surgeon at the end of the procedure.
|
Quadratus Lumborum II Group
n=20 Participants
The QL 2 group received 15 mL bupivacaine 0.25% on both sides for a total of 30 mL once the surgery is done but prior to extubation under ultrasound guidance.
|
|---|---|---|
|
Blood Pressure
Systolic pressure
|
134 mmHg
Standard Deviation 11.9
|
136 mmHg
Standard Deviation 15.9
|
|
Blood Pressure
Diastolic
|
80.1 mmHg
Standard Deviation 11.6
|
83.0 mmHg
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: up to 60 minutesTime until first analgesic request in minutes
Outcome measures
| Measure |
Conventional Therapy
n=20 Participants
Conventional therapy consists of the injection of 30 mL of bupivacaine 0.25% directly into the incision sites by the surgeon at the end of the procedure.
|
Quadratus Lumborum II Group
n=20 Participants
The QL 2 group received 15 mL bupivacaine 0.25% on both sides for a total of 30 mL once the surgery is done but prior to extubation under ultrasound guidance.
|
|---|---|---|
|
Time to First Dose of Analgesic Request
|
34.0 minutes
Standard Deviation 23.9
|
28.1 minutes
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: average 2 hoursPost anesthesia care unit (PACU) length of stay in hours
Outcome measures
| Measure |
Conventional Therapy
n=20 Participants
Conventional therapy consists of the injection of 30 mL of bupivacaine 0.25% directly into the incision sites by the surgeon at the end of the procedure.
|
Quadratus Lumborum II Group
n=20 Participants
The QL 2 group received 15 mL bupivacaine 0.25% on both sides for a total of 30 mL once the surgery is done but prior to extubation under ultrasound guidance.
|
|---|---|---|
|
PACU Length of Stay
|
2.18 hours
Standard Deviation 0.572
|
1.95 hours
Standard Deviation 0.822
|
SECONDARY outcome
Timeframe: Up to 48 hoursNumber of participants with somatic or visceral pain.
Outcome measures
| Measure |
Conventional Therapy
n=20 Participants
Conventional therapy consists of the injection of 30 mL of bupivacaine 0.25% directly into the incision sites by the surgeon at the end of the procedure.
|
Quadratus Lumborum II Group
n=20 Participants
The QL 2 group received 15 mL bupivacaine 0.25% on both sides for a total of 30 mL once the surgery is done but prior to extubation under ultrasound guidance.
|
|---|---|---|
|
Number of Participants With Pain
Somatic pain
|
3 Participants
|
2 Participants
|
|
Number of Participants With Pain
Visceral pain
|
18 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: the first 48 hours after the procedureNumber of participants with nausea
Outcome measures
| Measure |
Conventional Therapy
n=20 Participants
Conventional therapy consists of the injection of 30 mL of bupivacaine 0.25% directly into the incision sites by the surgeon at the end of the procedure.
|
Quadratus Lumborum II Group
n=20 Participants
The QL 2 group received 15 mL bupivacaine 0.25% on both sides for a total of 30 mL once the surgery is done but prior to extubation under ultrasound guidance.
|
|---|---|---|
|
Number of Participants With Nausea
POD1
|
8 Participants
|
6 Participants
|
|
Number of Participants With Nausea
POD2
|
4 Participants
|
2 Participants
|
|
Number of Participants With Nausea
POQ2
|
12 Participants
|
7 Participants
|
Adverse Events
Quadratus Lumborum II Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Therapy
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
Dr. Ali Shariat
Icahn School of Medicine at Mount Sinai
Phone: 212-523-2500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place