Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quadratus Lumborum II Group | Active Comparator | The QL 2 group will receive 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. |
|
| Conventional Therapy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Bupivacaine Hcl 0.25% Inj |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2 |
| Measure | Description | Time Frame |
|---|---|---|
| VAS Pain Scores | Visual analogue scale - total score from 0 to 10, with higher score indicating more pain | Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2 |
| Respiratory Rate | Respiratory rate in breaths per minute |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ali N Shariat | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai St. Lukes Hospital | New York | New York | 10025 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28579202 | Background | King WC, Chen JY, Belle SH, Courcoulas AP, Dakin GF, Flum DR, Hinojosa MW, Kalarchian MA, Mitchell JE, Pories WJ, Spaniolas K, Wolfe BM, Yanovski SZ, Engel SG, Steffen KJ. Use of prescribed opioids before and after bariatric surgery: prospective evidence from a U.S. multicenter cohort study. Surg Obes Relat Dis. 2017 Aug;13(8):1337-1346. doi: 10.1016/j.soard.2017.04.003. Epub 2017 Apr 7. | |
| 27755488 |
| Label | URL |
|---|---|
| King WC, Chen J-Y, Belle SH, et al.; Use of Prescribed Opioids Before and After Bariatric Surgery: Prospective Evidence from a U.S. Multicenter Cohort Study Surg Obes Relat Dis 2017; 13: 1337-1346. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Quadratus Lumborum II Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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. | Posted | Mean | Standard Deviation | mg IV morphine equivalents | Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2 |
|
48 hours
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ali Shariat | Icahn School of Medicine at Mount Sinai | 212-523-2500 | AliNima.Shariat@mountsinai.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 10, 2018 | Nov 3, 2022 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 26, 2018 | Nov 7, 2022 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 hour post op |
| Heart Rate | Heart rate in beats per minute | 1 hour after surgery |
| Blood Pressure | Both systolic and diastolic pressures | 1 hour after surgery |
| Time to First Dose of Analgesic Request | Time until first analgesic request in minutes | up to 60 minutes |
| PACU Length of Stay | Post anesthesia care unit (PACU) length of stay in hours | average 2 hours |
| Number of Participants With Pain | Number of participants with somatic or visceral pain. | Up to 48 hours |
| Number of Participants With Nausea | Number of participants with nausea | the first 48 hours after the procedure |
| Background |
| Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495. |
| 23591549 | Background | Albrecht E, Kirkham KR, Endersby RV, Chan VW, Jackson T, Okrainec A, Penner T, Jin R, Brull R. Ultrasound-guided transversus abdominis plane (TAP) block for laparoscopic gastric-bypass surgery: a prospective randomized controlled double-blinded trial. Obes Surg. 2013 Aug;23(8):1309-14. doi: 10.1007/s11695-013-0958-3. |
| Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarian Delivery. Reg Anesth Pain Med 2016; 41: 757-762. | View source |
| Albrecht E, Kirkham KR, Endersby RVW, et al. Ultrasound-Guided Transversus Abdominis Plane (TAP) Block for Laparoscopic Gastric-Bypass Surgery: a Prospective Randomized Controlled Double-Blinded Trial. Obes Surg 2013; 23: 1309-1314. | View source |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
| Existence of preexisting pain | Count of Participants | Participants |
|
| Pre Non-analgesic Meds | Count of Participants | Participants |
|
| Pre Analgesic Meds | Count of Participants | Participants |
|
| Recreational drug use | Count of Participants | Participants |
|
| Preop Systolic Blood Pressure (BP) | Mean | Standard Deviation | mmHg |
|
| Preop Diastolic BP | Mean | Standard Deviation | mmHg |
|
| Preop Mean Arterial Pressure (MAP) | Mean | Standard Deviation | mmHg |
|
| Preop Heart Rate (HR) | Mean | Standard Deviation | beats per minute |
|
| Preop Respiratory Rate (RR) | Mean | Standard Deviation | breaths per minute |
|
| Preop Oxygen Saturation (SpO2) | Oxygen saturation measured by pulse oximetry | Mean | Standard Deviation | percent |
|
| 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. |
|
|
| Secondary | VAS Pain Scores | Visual analogue scale - total score from 0 to 10, with higher score indicating more pain | 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. | Posted | Mean | Standard Deviation | score on a scale | Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2 |
|
|
|
| Secondary | Respiratory Rate | Respiratory rate in breaths per minute | Posted | Mean | Standard Deviation | breaths per minute | 1 hour post op |
|
|
|
| Secondary | Heart Rate | Heart rate in beats per minute | Posted | Mean | Standard Deviation | beats per minute | 1 hour after surgery |
|
|
|
| Secondary | Blood Pressure | Both systolic and diastolic pressures | Posted | Mean | Standard Deviation | mmHg | 1 hour after surgery |
|
|
|
| Secondary | Time to First Dose of Analgesic Request | Time until first analgesic request in minutes | Posted | Mean | Standard Deviation | minutes | up to 60 minutes |
|
|
|
| Secondary | PACU Length of Stay | Post anesthesia care unit (PACU) length of stay in hours | Posted | Mean | Standard Deviation | hours | average 2 hours |
|
|
|
| Secondary | Number of Participants With Pain | Number of participants with somatic or visceral pain. | Posted | Count of Participants | Participants | Up to 48 hours |
|
|
|
| Secondary | Number of Participants With Nausea | Number of participants with nausea | Posted | Count of Participants | Participants | the first 48 hours after the procedure |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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 | 0 | 20 | 0 | 20 | 0 | 20 |
Not provided
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| POQ2 - PACU hour 2 |
|
|
| POD 0 |
|
|
| POD1 |
|
|
| POD2 |
|
|
| POD2 |
|