High BMI, Morbid Obesity
Conditions
Keywords
Sleeve gastrectomy, Quadratus lumborum block, Bariatric surgery
Brief summary
The QL 2 block is a novel fascial plane block recently described by Blanco and colleagues in which local anesthetic is deposited adjacent to the antero-lateral aspect of the quadratus lumborum muscle. This results in posterior spread of local anesthetic through the middle layer of the thoraco-lumbar fascia, which theoretically communicates with the paravertebral space resulting in potentially longer-lasting and denser analgesia than wound infiltration. The QL 2 block derives from the TAP block, which is also a fascial plane block that is commonly used to treat pain following surgery involving the anterior abdominal wall. However, the QL block's more posterior location has recently been shown to provide a longer lasting and more profound analgesic effect than the TAP block, possibly by communicating with the paravertebral space. Although the TAP has been shown to be effective in a variety of surgical procedures involving an anterior abdominal wall incision including laparoscopic bariatric surgery the QL 2 block has until now, not been studied in the context of bariatric surgery.
Detailed description
The QL 2 block is a novel fascial plane block recently described by Blanco and colleagues in which local anesthetic is deposited adjacent to the antero-lateral aspect of the quadratus lumborum muscle. This results in posterior spread of local anesthetic through the middle layer of the thoraco-lumbar fascia, which theoretically communicates with the paravertebral space resulting in potentially longer-lasting and denser analgesia than wound infiltration. Like the more commonly used transversus abdominis plane (TAP) block, the QL 2 block targets the anterior rami of T7-T12, ilioinguinal, iliohypogastric, and the lateral cutaneous branches of L1-L3. The QL 2 block derives from the TAP block, which is also a fascial plane block that is commonly used to treat pain following surgery involving the anterior abdominal wall. However, the QL block's more posterior location has recently been shown to provide a longer lasting and more profound analgesic effect than the TAP block, possibly by communicating with the paravertebral space. Although the TAP has been shown to be effective in a variety of surgical procedures involving an anterior abdominal wall incision including laparoscopic bariatric surgery the QL 2 block has until now, not been studied in the context of bariatric surgery. Conventional therapy has consisted of surgical infiltration of the incision ports with bupivacaine 0.25%. The study team proposes a study to compare the analgesic effects of the QL 2 block with conventional therapy, consisting of surgical wound infiltration, for postoperative analgesia following laparoscopic gastric sleeve gastrectomy.
Interventions
DRUGBupivacaine
Bupivacaine Hcl 0.25% Inj
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled to undergo laparoscopic gastric sleeve gastrectomy * 18-65 years of age * BMI\> 35 kg/m2.
Exclusion criteria
* Contraindications to administration of local anesthesia (e.g. local anesthetic allergy) * Contraindication/allergy to acetaminophen or ketorolac * History of substance abuse or chronic opioid use * Coagulopathy * Patients receiving systemic anticoagulation * Local infection * ASA 4
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Amount of Opioid Consumption During and After Procedure | Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2 | The amount of opioid consumption (in mg IV morphine equivalents) during and after procedure (100mcg fentanyl= 10mg morphine) (1.5mg dilaudid=10mg morphine) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Rate | 1 hour post op | Respiratory rate in breaths per minute |
| Heart Rate | 1 hour after surgery | Heart rate in beats per minute |
| Blood Pressure | 1 hour after surgery | Both systolic and diastolic pressures |
| VAS Pain Scores | Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2 | Visual analogue scale - total score from 0 to 10, with higher score indicating more pain |
| PACU Length of Stay | average 2 hours | Post anesthesia care unit (PACU) length of stay in hours |
| Number of Participants With Pain | Up to 48 hours | Number of participants with somatic or visceral pain. |
| Number of Participants With Nausea | the first 48 hours after the procedure | Number of participants with nausea |
| Time to First Dose of Analgesic Request | up to 60 minutes | Time until first analgesic request in minutes |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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 | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Conventional Therapy | Quadratus Lumborum II Group | Total |
|---|---|---|---|
| Age, Continuous | 39.0 years STANDARD_DEVIATION 11.3 | 37.4 years STANDARD_DEVIATION 9.84 | 38.2 years STANDARD_DEVIATION 10.5 |
| Body Mass Index (BMI) | 42.9 kg/m2 STANDARD_DEVIATION 5.5 | 43.3 kg/m2 STANDARD_DEVIATION 7.46 | 43.1 kg/m2 STANDARD_DEVIATION 6.47 |
| Existence of preexisting pain | 5 Participants | 5 Participants | 10 Participants |
| Pre Analgesic Meds | 2 Participants | 1 Participants | 3 Participants |
| Pre Non-analgesic Meds | 12 Participants | 13 Participants | 25 Participants |
| Preop Diastolic BP | 80.0 mmHg STANDARD_DEVIATION 8.19 | 79.5 mmHg STANDARD_DEVIATION 8.24 | 79.7 mmHg STANDARD_DEVIATION 8.11 |
| Preop Heart Rate (HR) | 87.4 beats per minute STANDARD_DEVIATION 12 | 84.3 beats per minute STANDARD_DEVIATION 15.7 | 85.8 beats per minute STANDARD_DEVIATION 13.9 |
| Preop Mean Arterial Pressure (MAP) | 90.2 mmHg STANDARD_DEVIATION 22.4 | 95.2 mmHg STANDARD_DEVIATION 9.25 | 92.7 mmHg STANDARD_DEVIATION 17.1 |
| Preop Oxygen Saturation (SpO2) | 98.5 percent STANDARD_DEVIATION 0.82 | 98.0 percent STANDARD_DEVIATION 1.34 | 98.3 percent STANDARD_DEVIATION 1.12 |
| Preop Respiratory Rate (RR) | 16.3 breaths per minute STANDARD_DEVIATION 1.14 | 17.9 breaths per minute STANDARD_DEVIATION 2.66 | 17.1 breaths per minute STANDARD_DEVIATION 2.15 |
| Preop Systolic Blood Pressure (BP) | 125 mmHg STANDARD_DEVIATION 9.51 | 127 mmHg STANDARD_DEVIATION 14.2 | 126 mmHg STANDARD_DEVIATION 12 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Recreational drug use | 4 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Female | 17 Participants | 16 Participants | 33 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
The Amount of Opioid Consumption During and After Procedure
The amount of opioid consumption (in mg IV morphine equivalents) during and after procedure (100mcg fentanyl= 10mg morphine) (1.5mg dilaudid=10mg morphine)
Time frame: Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Conventional Therapy | The Amount of Opioid Consumption During and After Procedure | Intraop | 26.3 mg IV morphine equivalents | Standard Deviation 12.4 |
| Conventional Therapy | The Amount of Opioid Consumption During and After Procedure | POQ1 - PACU hour 1 | 5.49 mg IV morphine equivalents | Standard Deviation 3.49 |
| Conventional Therapy | The Amount of Opioid Consumption During and After Procedure | POQ2 - PACU hour 2 | 2.80 mg IV morphine equivalents | Standard Deviation 1.66 |
| Conventional Therapy | The Amount of Opioid Consumption During and After Procedure | POD 0 | 4.14 mg IV morphine equivalents | Standard Deviation 5.12 |
| Conventional Therapy | The Amount of Opioid Consumption During and After Procedure | POD1 | 3.13 mg IV morphine equivalents | Standard Deviation 4.72 |
| Conventional Therapy | The Amount of Opioid Consumption During and After Procedure | POD2 | 0.938 mg IV morphine equivalents | Standard Deviation 1.46 |
| Quadratus Lumborum II Group | The Amount of Opioid Consumption During and After Procedure | POD1 | 2.75 mg IV morphine equivalents | Standard Deviation 3.52 |
| Quadratus Lumborum II Group | The Amount of Opioid Consumption During and After Procedure | Intraop | 27.1 mg IV morphine equivalents | Standard Deviation 11.9 |
| Quadratus Lumborum II Group | The Amount of Opioid Consumption During and After Procedure | POD 0 | 2.53 mg IV morphine equivalents | Standard Deviation 3.16 |
| Quadratus Lumborum II Group | The Amount of Opioid Consumption During and After Procedure | POQ1 - PACU hour 1 | 5.52 mg IV morphine equivalents | Standard Deviation 3.64 |
| Quadratus Lumborum II Group | The Amount of Opioid Consumption During and After Procedure | POD2 | 0.750 mg IV morphine equivalents | Standard Deviation 1.43 |
| Quadratus Lumborum II Group | The Amount of Opioid Consumption During and After Procedure | POQ2 - PACU hour 2 | 1.68 mg IV morphine equivalents | Standard Deviation 2.1 |
Secondary
Blood Pressure
Both systolic and diastolic pressures
Time frame: 1 hour after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Conventional Therapy | Blood Pressure | Systolic pressure | 134 mmHg | Standard Deviation 11.9 |
| Conventional Therapy | Blood Pressure | Diastolic | 80.1 mmHg | Standard Deviation 11.6 |
| Quadratus Lumborum II Group | Blood Pressure | Systolic pressure | 136 mmHg | Standard Deviation 15.9 |
| Quadratus Lumborum II Group | Blood Pressure | Diastolic | 83.0 mmHg | Standard Deviation 10.8 |
Secondary
Heart Rate
Heart rate in beats per minute
Time frame: 1 hour after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Therapy | Heart Rate | 85.3 beats per minute | Standard Deviation 14 |
| Quadratus Lumborum II Group | Heart Rate | 7.3 beats per minute | Standard Deviation 12.5 |
Secondary
Number of Participants With Nausea
Number of participants with nausea
Time frame: the first 48 hours after the procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Conventional Therapy | Number of Participants With Nausea | POQ2 | 12 Participants |
| Conventional Therapy | Number of Participants With Nausea | POD1 | 8 Participants |
| Conventional Therapy | Number of Participants With Nausea | POD2 | 4 Participants |
| Quadratus Lumborum II Group | Number of Participants With Nausea | POQ2 | 7 Participants |
| Quadratus Lumborum II Group | Number of Participants With Nausea | POD1 | 6 Participants |
| Quadratus Lumborum II Group | Number of Participants With Nausea | POD2 | 2 Participants |
Secondary
Number of Participants With Pain
Number of participants with somatic or visceral pain.
Time frame: Up to 48 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Conventional Therapy | Number of Participants With Pain | Somatic pain | 3 Participants |
| Conventional Therapy | Number of Participants With Pain | Visceral pain | 18 Participants |
| Quadratus Lumborum II Group | Number of Participants With Pain | Somatic pain | 2 Participants |
| Quadratus Lumborum II Group | Number of Participants With Pain | Visceral pain | 18 Participants |
Secondary
PACU Length of Stay
Post anesthesia care unit (PACU) length of stay in hours
Time frame: average 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Therapy | PACU Length of Stay | 2.18 hours | Standard Deviation 0.572 |
| Quadratus Lumborum II Group | PACU Length of Stay | 1.95 hours | Standard Deviation 0.822 |
Secondary
Respiratory Rate
Respiratory rate in breaths per minute
Time frame: 1 hour post op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Therapy | Respiratory Rate | 22.5 breaths per minute | Standard Deviation 2.72 |
| Quadratus Lumborum II Group | Respiratory Rate | 17.0 breaths per minute | Standard Deviation 4.8 |
Secondary
Time to First Dose of Analgesic Request
Time until first analgesic request in minutes
Time frame: up to 60 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Therapy | Time to First Dose of Analgesic Request | 34.0 minutes | Standard Deviation 23.9 |
| Quadratus Lumborum II Group | Time to First Dose of Analgesic Request | 28.1 minutes | Standard Deviation 18.4 |
Secondary
VAS Pain Scores
Visual analogue scale - total score from 0 to 10, with higher score indicating more pain
Time frame: Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Conventional Therapy | VAS Pain Scores | POQ2 - PACU hour 2 | 4.37 score on a scale | Standard Deviation 2.27 |
| Conventional Therapy | VAS Pain Scores | POD1 | 6.20 score on a scale | Standard Deviation 2.71 |
| Conventional Therapy | VAS Pain Scores | POD 0 | 5.85 score on a scale | Standard Deviation 2.89 |
| Conventional Therapy | VAS Pain Scores | POD2 | 5.00 score on a scale | Standard Deviation 2.57 |
| Conventional Therapy | VAS Pain Scores | POQ1 - PACU hour 1 | 6.60 score on a scale | Standard Deviation 2.11 |
| Quadratus Lumborum II Group | VAS Pain Scores | POD2 | 3.28 score on a scale | Standard Deviation 1.87 |
| Quadratus Lumborum II Group | VAS Pain Scores | POQ1 - PACU hour 1 | 6.15 score on a scale | Standard Deviation 1.95 |
| Quadratus Lumborum II Group | VAS Pain Scores | POQ2 - PACU hour 2 | 3.11 score on a scale | Standard Deviation 1.59 |
| Quadratus Lumborum II Group | VAS Pain Scores | POD 0 | 4.80 score on a scale | Standard Deviation 2.33 |
| Quadratus Lumborum II Group | VAS Pain Scores | POD1 | 4.05 score on a scale | Standard Deviation 1.96 |