Unilateral TAP Block for Laparoscopic Gastric Sleeve Surgery
|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: NCT03856788|
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : May 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Laparoscopic Sleeve Gastrectomy Subcostal Transversus Abdominis Plane Block||Drug: Saline Drug: Bupivacaine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The study consists of two study arms. Patients will be getting a subcostal transversus abdominis plane block with either bupivacaine or saline.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Group allocation and instructions on preparing the injectate solution for the subcostal TAP block will be included in a sealed envelope. On the day of the surgery, the group allocation will be revealed to an anesthesiologist not involved with the research study. The anesthesiologist not involved in the study or the care of the patient will prepare the solution to be used for the subcostal TAP block.|
|Official Title:||Effect of Unilateral Ultrasound-Guided Subcostal Transversus Abdominis Plane Block in Patients Undergoing Laparoscopic Sleeve Gastrectomy|
|Actual Study Start Date :||December 10, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||February 2021|
Placebo Comparator: Saline
Patients will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with normal saline on the ipsilateral side as the extraction site.
40 mL sterile normal saline
Active Comparator: Bupivacaine
Patients will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with bupivacaine on the ipsilateral side as the extraction site.
40 mL 0.25% bupivacaine
- Amount of 24 hour opioid consumption [ Time Frame: 24 Hours ]Amount of intravenous (IV) opioid consumption within 24-hour period
- Amount of intraoperative IV opioid consumption [ Time Frame: average 2-3 Hours ]Amount of intravenous opioid consumption during the surgery
- Amount of post-operative IV opioid consumption [ Time Frame: average 2 Days ]Amount of intravenous opioid consumption after the surgery
- Pain Score [ Time Frame: up to 24 Hours ]11-point numeric pain score Likert scale, full scale from 0-10, with higher score indicating more pain
- Time to breakthrough pain after surgery [ Time Frame: 24 Hours ]The time after surgery to which the patients require their first dose of opioid pain medication.
- Area of pain on the body after surgery [ Time Frame: 24 Hours ]Patients will be asked for the areas of pain (right upper quadrant, left upper quadrant, right lower quadrant, or left lower quadrant) after surgery.
- Presence of postoperative nausea [ Time Frame: 24 Hours ]Compare presence of nausea after surgery. (yes/no)
- Analgesia satisfaction score at end of hospital stay [ Time Frame: average 1 Week ]The analgesia satisfaction score after hospital discharge. Likert scale, full scale from 1-10, with higher score indicating more satisfaction with their analgesia
- Hospital length of stay [ Time Frame: average 3 Days ]Length of hospital stay.
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): NCT03856788
|Contact: James Leader, MPA||(212) 241-5468 ext x45468||James.Leader@mountsinai.org|
|United States, New York|
|Mount Sinai Brooklyn||Recruiting|
|New York, New York, United States, 11217|
|Contact: James Leader, MPA 212-241-5468 ext x45468 James.Leader@mountsinai.org|
|Principal Investigator: Christina Jeng, MD|
|Principal Investigator:||Christina Jeng, MD||Icahn School of Medicine at Mount Sinai|