Efficacy Of Quadratus Lumborum II Block For Laparoscopic Sleeve Gastrectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04073056|
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Morbid Obesity High BMI||Drug: Bupivacaine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Quadratus Lumborum II Block vs Conventional Therapy Alone For Laparoscopic Sleeve Gastrectomy|
|Actual Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||December 1, 2020|
|Estimated Study Completion Date :||December 1, 2020|
Active Comparator: Quadratus Lumborum II Group
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.
Bupivacaine Hcl 0.25% Inj
Active Comparator: 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 Hcl 0.25% Inj
- The amount of opioid consumption [ Time Frame: First 48 hours ]The amount of opioid consumption (in mg IV morphine equivalents) postoperatively during the first 48 hours after the procedure.
- VAS pain scores [ Time Frame: Up to 48 hours ]Visual analogue scale - total score from 0 to 10, with higher score indicating more pain
- Respiratory rate [ Time Frame: Up to 48 hours ]Respiratory rate in breaths per minute
- Heart rate [ Time Frame: Up to 48 hours ]Heart rate in beats per minute
- Blood pressure [ Time Frame: Up to 48 hours ]Both systolic and diastolic pressures
- Time to first dose of opioid administration [ Time Frame: Up to 48 hours ]Time to first does of opioid administration in hours
- PACU length of stay [ Time Frame: Up to 48 hours ]Post anesthesia care unit (PACU) length of stay in hours
- Incidence of location of pain [ Time Frame: Up to 48 hours ]Location of pain in the abdomen by quadrants as assessed by physical exam.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04073056
|Contact: Jonathan Epstein, MDemail@example.com|
|Contact: Ali N Shariat, MDfirstname.lastname@example.org|
|United States, New York|
|Mount Sinai St. Lukes Hospital||Recruiting|
|New York, New York, United States, 10025|
|Contact: Jonathan Epstein, MD 212-523-4000 email@example.com|
|Contact: Ali N Shariat, MD 212-523-6923 firstname.lastname@example.org|
|Principal Investigator: Ali N Shariat, MD|
|Principal Investigator:||Ali N Shariat||Icahn School of Medicine at Mount Sinai|