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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
Sponsor:
Information provided by (Responsible Party):
Christina Jeng, Icahn School of Medicine at Mount Sinai

Brief Summary:
The study team will be assessing if the unilateral subcostal transversus abdominis plane (TAP) block can decrease pain and improve outcomes following laparoscopic sleeve gastrectomy surgeries.

Condition or disease Intervention/treatment Phase
Laparoscopic Sleeve Gastrectomy Subcostal Transversus Abdominis Plane Block Drug: Saline Drug: Bupivacaine Phase 4

Detailed Description:
This study will be a double-blinded randomized control trial. Patients will be randomized into one of two groups. Patients in Group 1 will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with 40 mL 0.25% bupivacaine on the ipsilateral side as the extraction site. Patients in Group 2 will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with 40 mL sterile normal saline on the ipsilateral side as the extraction site. Investigators will be blinded to the randomization of these patients. Following performance of these blocks, patients will receive standard care for the surgery as well as during the postoperative recovery period. Data will be obtained from the EPIC electronic medical record, and from the anesthesia computer record. Patients will be asked postoperatively to assess items such as their nausea and pain scores. Patients will also be contacted by phone within 1-2 days of discharge to obtain analgesic satisfaction scores. This data will be collected on the Redcap server.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
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.
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Saline
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.
Drug: Bupivacaine
40 mL 0.25% bupivacaine




Primary Outcome Measures :
  1. Amount of 24 hour opioid consumption [ Time Frame: 24 Hours ]
    Amount of intravenous (IV) opioid consumption within 24-hour period


Secondary Outcome Measures :
  1. Amount of intraoperative IV opioid consumption [ Time Frame: average 2-3 Hours ]
    Amount of intravenous opioid consumption during the surgery

  2. Amount of post-operative IV opioid consumption [ Time Frame: average 2 Days ]
    Amount of intravenous opioid consumption after the surgery

  3. 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

  4. 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.

  5. 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.

  6. Presence of postoperative nausea [ Time Frame: 24 Hours ]
    Compare presence of nausea after surgery. (yes/no)

  7. 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

  8. Hospital length of stay [ Time Frame: average 3 Days ]
    Length of hospital stay.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults 18-80 years old
  • Candidate for general anesthesia
  • Undergoing laparoscopic sleeve gastrectomy
  • Patients of participating surgeons

Exclusion Criteria:

  • Prior bariatric surgery of any kind
  • Previous abdominoplasty
  • Allergy or intolerance to one of the study medications
  • ASA > 4
  • Chronic opioid use (taking opioids for longer than 3 months or daily oral morphine equivalent of >5mg/day for one month)
  • History of alcohol/drug abuse
  • History of hepatic or renal insufficiency
  • Patient refusal

Information from the National Library of Medicine

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


Contacts
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Contact: James Leader, MPA (212) 241-5468 ext x45468 James.Leader@mountsinai.org

Locations
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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         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Christina Jeng, MD Icahn School of Medicine at Mount Sinai
Additional Information:
Publications:

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Responsible Party: Christina Jeng, Associate Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03856788    
Other Study ID Numbers: GCO 18-1886
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Christina Jeng, Icahn School of Medicine at Mount Sinai:
Randomized control trial
Subcostal transversus abdominis plane block
Laparoscopic sleeve gastrectomy
Regional anesthesia
Opioid consumption
Bariatrics
Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents