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Effect of Ultrasound-guided Transversus Abdominis Plane Block After Laparoscopic Bariatric Surgery

Primary Purpose

Postoperative Nausea and Vomiting, Postoperative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Normal saline
Ropivacaine at high concentration
Ropivacaine and dexamethasone
Sponsored by
Tianjin Medical University General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring Ropivacaine, Transversus abdominis plane block, opioid consumption, Dexamethasone

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject is scheduled to undergo Laparoscopic Bariatric Surgery
  2. Subject's American Society of Anesthesiologists physical status is I-III.
  3. BMI>35kg/m2
  4. The subject's parent/legally authorized guardian has given written informed consent to participate

Exclusion Criteria:

  1. Subject has a diagnosis of renal or liver failure.
  2. Subject has a diagnosis of mental illness
  3. Subject is allergy and contraindication to Ropivacaine.
  4. Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre-existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery.
  5. Subject has any contraindication for the use
  6. Subject is pregnant or breast-feeding.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Arm Label

    Normal Saline

    Ropivacaine at high concentration

    Ropivacaine and dexamethasone

    Arm Description

    Before the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side.

    Before the induction of anesthesia, 0.375% Ropivacaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side

    Before the induction of anesthesia, 0.375% Ropivacaine and 5.0mg dexamethasone are used for bilateral transversus abdominis plane block in a volume of 20 mL of each side

    Outcomes

    Primary Outcome Measures

    Postoperative nausea and vomiting
    The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).

    Secondary Outcome Measures

    cumulative Sufentanyl Consumption during surgery
    Each patient was administered sufentanil for analgesic during surgery
    cumulative Sufentanyl Consumption after surgery
    Each patient was administered analgesics using a PCA pump containing sufentanil (100μg) in normal saline at a totalvolume of 100 ml after leaving PACU. This device was set to deliver a basal infusion of 2 ml/h and bolus doses of 0.5ml with a 15-min lockout period. Sufentanyl cumulative consumption is recorded 24 hours postoperative
    Time of First Postoperative Analgesic Requiremen
    First postoperative pain (NRS≥5) is initially controlled by titration of sufentany
    Total Dose of First Postoperative Analgesic Requirement
    First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.
    The incidence of Side Effects
    The number of patients with side effects including nausea, vomiting, dizziness, headache, shivering, and pruritus is recorded for 48 hours postoperatively
    Apfel score
    The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).
    Time to ambulation
    The obesity's time to ambulation after surge
    Mean time until passage of flatus
    Gastrointestinal motility was evaluated by recording mean time until passage of flatus
    Diffusion area of local anesthetics after transversus abdominis plane block
    Diffusion area of local anesthetics after transversus abdominis plane block was calculated under ultrasound assistance.
    Normalized Area of Hyperalgesia Around the Incision
    The skin around the incision is stimulated in steps of 5 mm at intervals of 1 s starting outside of the hyperalgesic area in the direction of the incision. The distance from the incision to the first point where a 'painful', 'sore' or 'sharper'feeling occurred is measured and noted. This measurement is repeated at predefined radial lines around the incision. To eliminate the variable length of incision, this length is subtracted from the longer diameter leaving four radial distances from the end and from the middle of the incision. The normalized area of hyperalgesia is calculated by summing up the areas of the remaining four triangles measured by and Von Frey filament.

    Full Information

    First Posted
    January 24, 2022
    Last Updated
    March 16, 2022
    Sponsor
    Tianjin Medical University General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05286008
    Brief Title
    Effect of Ultrasound-guided Transversus Abdominis Plane Block After Laparoscopic Bariatric Surgery
    Official Title
    Impact of Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative Nausea and Vomiting and Early Outcome After Laparoscopic Bariatric Surgery: a Randomized Double-Blinded Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 18, 2022 (Anticipated)
    Primary Completion Date
    September 30, 2022 (Anticipated)
    Study Completion Date
    October 15, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tianjin Medical University General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To explore and compare Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative nausea and vomiting and Early Outcome After Laparoscopic Bariatric Surgery To evaluate and examine TAPB can reduce the application of intraoperative and postoperative opioids and the duration of analgesia
    Detailed Description
    Poor postoperative nausea and vomiting control is a leading factor that hinders the physical rehabilitation, and causes acute cognitive impairment and chronic pain syndrome. Recently, the multimodal analgesia strategies to minimise opioid-related side effects are highly desirable in open surgical procedures. The transversus abdominis plane block is a novel technique involving injection of local anaesthetic between the internal oblique and the transversus abdominis muscles of the abdominal wall. Although ropivacaine is most commonly used for this technique, the analgesic duration remains not dissatisfied. Herein, investigators will evaluate the efficacy of ultrasound-guided transversus abdominis plane(USG- TAP) block with ropivacaine in Laparoscopic Bariatric Surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Nausea and Vomiting, Postoperative Pain
    Keywords
    Ropivacaine, Transversus abdominis plane block, opioid consumption, Dexamethasone

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    Double (Investigator, Outcomes Assessor)
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Normal Saline
    Arm Type
    Placebo Comparator
    Arm Description
    Before the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side.
    Arm Title
    Ropivacaine at high concentration
    Arm Type
    Experimental
    Arm Description
    Before the induction of anesthesia, 0.375% Ropivacaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side
    Arm Title
    Ropivacaine and dexamethasone
    Arm Type
    Experimental
    Arm Description
    Before the induction of anesthesia, 0.375% Ropivacaine and 5.0mg dexamethasone are used for bilateral transversus abdominis plane block in a volume of 20 mL of each side
    Intervention Type
    Drug
    Intervention Name(s)
    Normal saline
    Other Intervention Name(s)
    0. 9% Sodium Chloride Injection
    Intervention Description
    Before the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine at high concentration
    Other Intervention Name(s)
    Ropivacaine Hydrochloride Injection
    Intervention Description
    Before the induction of anesthesia,0.375% ropivacaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine and dexamethasone
    Other Intervention Name(s)
    Ropivacaine Hydrochloride Injection
    Intervention Description
    Before the induction of anesthesia, 0.375% Ropivacaine and 5.0mg dexamethasone are used for bilateral transversus abdominis plane block in a volume of 20 mL of each side
    Primary Outcome Measure Information:
    Title
    Postoperative nausea and vomiting
    Description
    The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).
    Time Frame
    72 hours after surgery
    Secondary Outcome Measure Information:
    Title
    cumulative Sufentanyl Consumption during surgery
    Description
    Each patient was administered sufentanil for analgesic during surgery
    Time Frame
    during surgery
    Title
    cumulative Sufentanyl Consumption after surgery
    Description
    Each patient was administered analgesics using a PCA pump containing sufentanil (100μg) in normal saline at a totalvolume of 100 ml after leaving PACU. This device was set to deliver a basal infusion of 2 ml/h and bolus doses of 0.5ml with a 15-min lockout period. Sufentanyl cumulative consumption is recorded 24 hours postoperative
    Time Frame
    48 hours after surgery
    Title
    Time of First Postoperative Analgesic Requiremen
    Description
    First postoperative pain (NRS≥5) is initially controlled by titration of sufentany
    Time Frame
    1hour after surgery
    Title
    Total Dose of First Postoperative Analgesic Requirement
    Description
    First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.
    Time Frame
    1hour after surgery
    Title
    The incidence of Side Effects
    Description
    The number of patients with side effects including nausea, vomiting, dizziness, headache, shivering, and pruritus is recorded for 48 hours postoperatively
    Time Frame
    48 hours after surgery
    Title
    Apfel score
    Description
    The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).
    Time Frame
    The 1 day before the surgery
    Title
    Time to ambulation
    Description
    The obesity's time to ambulation after surge
    Time Frame
    12 hours after surgery
    Title
    Mean time until passage of flatus
    Description
    Gastrointestinal motility was evaluated by recording mean time until passage of flatus
    Time Frame
    72 hours after surgery
    Title
    Diffusion area of local anesthetics after transversus abdominis plane block
    Description
    Diffusion area of local anesthetics after transversus abdominis plane block was calculated under ultrasound assistance.
    Time Frame
    30 minutes after transversus abdominis plane block
    Title
    Normalized Area of Hyperalgesia Around the Incision
    Description
    The skin around the incision is stimulated in steps of 5 mm at intervals of 1 s starting outside of the hyperalgesic area in the direction of the incision. The distance from the incision to the first point where a 'painful', 'sore' or 'sharper'feeling occurred is measured and noted. This measurement is repeated at predefined radial lines around the incision. To eliminate the variable length of incision, this length is subtracted from the longer diameter leaving four radial distances from the end and from the middle of the incision. The normalized area of hyperalgesia is calculated by summing up the areas of the remaining four triangles measured by and Von Frey filament.
    Time Frame
    48 hours after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject is scheduled to undergo Laparoscopic Bariatric Surgery Subject's American Society of Anesthesiologists physical status is I-III. BMI>35kg/m2 The subject's parent/legally authorized guardian has given written informed consent to participate Exclusion Criteria: Subject has a diagnosis of renal or liver failure. Subject has a diagnosis of mental illness Subject is allergy and contraindication to Ropivacaine. Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre-existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery. Subject has any contraindication for the use Subject is pregnant or breast-feeding.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Guolin Wang, MD
    Phone
    +8615822855556
    Email
    wangguolinhad@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guolin Wang, MD
    Organizational Affiliation
    Tianjin Medical University General Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effect of Ultrasound-guided Transversus Abdominis Plane Block After Laparoscopic Bariatric Surgery

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