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Efficacy and Safety of Erector Spinal Plane Block (ESPB) for Analgesia in Laparoscopic Cholecystectomy

Primary Purpose

Analgesia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Erector spinal plane block
Sponsored by
Beijing Tsinghua Chang Gung Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia focused on measuring erector spinal plane block, analgesia, laparoscopic cholecystectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status 1-3
  • Scheduled for elective laparoscopic cholecystectomy surgery under general anesthesia

Exclusion Criteria:

  • patient refusal
  • pregnancy
  • history of allergy to study drugs
  • neurological and cognitive disorders
  • coagulopathy
  • chronic pain disorders
  • infections at the injection site
  • history of abdominal surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    Erector spinal plane block group (ESPB group)

    Vertebral side block group (VSB group)

    Local block group （LB group）

    Arm Description

    After induction of general anesthesia, pre-operative ultrasound-guided bilateral erector spinae plane block will be performed in the ESPB group.

    After induction of general anesthesia, pre-operative ultrasound-guided bilateral vertebral side block will be performed in the VSB group.

    Local block will be performed at the surgical incisions after the surgery under general anesthesia.

    Outcomes

    Primary Outcome Measures

    Pain intensity at rest(Hour 2)
    Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest two hours after the surgery.
    Pain intensity at rest (Hour 6)
    Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest six hours after the surgery.
    Pain intensity at rest (Hour 24)
    Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest 24 hours after the surgery.

    Secondary Outcome Measures

    The overall dose of remifentanil
    The overall dose of remifentanil used in the surgery.

    Full Information

    First Posted
    November 3, 2020
    Last Updated
    November 23, 2020
    Sponsor
    Beijing Tsinghua Chang Gung Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04648345
    Brief Title
    Efficacy and Safety of Erector Spinal Plane Block (ESPB) for Analgesia in Laparoscopic Cholecystectomy
    Official Title
    Efficacy and Safety of Erector Spinal Plane Block (ESPB) for Intraoperative and Postoperative Analgesia in Laparoscopic Cholecystectomy : A Randomized, Single-blind，Controlled Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2020 (Anticipated)
    Primary Completion Date
    March 2021 (Anticipated)
    Study Completion Date
    May 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Beijing Tsinghua Chang Gung Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    Purpose: to evaluate the efficacy and safety of erector spinal block (ESB) for analgesia in laparoscopic cholecystectomy（LC）. Method: This study is a randomized, single-blind, controlled clinical trial. Pre-operative ultrasound-guided bilateral erector spinae plane block will be performed in the ESPB group. Vertebral side block will be performed in the VSB group. And the control group will receive local anaesthesia after the surgery. Intraoperative and postoperative analgesia effect and side effects will be compared between the three groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Analgesia
    Keywords
    erector spinal plane block, analgesia, laparoscopic cholecystectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A randomized, single-blinded, controlled clinical trial
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Erector spinal plane block group (ESPB group)
    Arm Type
    Experimental
    Arm Description
    After induction of general anesthesia, pre-operative ultrasound-guided bilateral erector spinae plane block will be performed in the ESPB group.
    Arm Title
    Vertebral side block group (VSB group)
    Arm Type
    Active Comparator
    Arm Description
    After induction of general anesthesia, pre-operative ultrasound-guided bilateral vertebral side block will be performed in the VSB group.
    Arm Title
    Local block group （LB group）
    Arm Type
    Placebo Comparator
    Arm Description
    Local block will be performed at the surgical incisions after the surgery under general anesthesia.
    Intervention Type
    Procedure
    Intervention Name(s)
    Erector spinal plane block
    Other Intervention Name(s)
    Vertebral side block, Local block
    Intervention Description
    After induction of general anesthesia, pre-operative ultrasound-guided bilateral erector spinae plane block/ vertebral side block will be performed in the ESPB/VSB group. Local block will be performed at the surgical incisions after the surgery under general anesthesia. All the intervention will be performed without patients' awareness.
    Primary Outcome Measure Information:
    Title
    Pain intensity at rest(Hour 2)
    Description
    Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest two hours after the surgery.
    Time Frame
    Hour 2
    Title
    Pain intensity at rest (Hour 6)
    Description
    Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest six hours after the surgery.
    Time Frame
    Hour 6
    Title
    Pain intensity at rest (Hour 24)
    Description
    Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest 24 hours after the surgery.
    Time Frame
    Hour 24
    Secondary Outcome Measure Information:
    Title
    The overall dose of remifentanil
    Description
    The overall dose of remifentanil used in the surgery.
    Time Frame
    During the surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status 1-3 Scheduled for elective laparoscopic cholecystectomy surgery under general anesthesia Exclusion Criteria: patient refusal pregnancy history of allergy to study drugs neurological and cognitive disorders coagulopathy chronic pain disorders infections at the injection site history of abdominal surgery
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Siyi YAN, MD
    Phone
    86+010-56119610
    Email
    yansiyi03@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chen Yu, MD
    Phone
    86+010-56119353
    Email
    yca01089@btch.edu.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficacy and Safety of Erector Spinal Plane Block (ESPB) for Analgesia in Laparoscopic Cholecystectomy

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