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Effectiveness of TAP (Transversus Abdominis Plane) Block for Abdominal Aortic Surgery

Primary Purpose

Abdominal Aortic Aneurysm, Abdominal Aortic Stenosis, Syndrome, Leriche

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ropivacaine
normal saline
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm focused on measuring Abdominal aorta, TAP

Eligibility Criteria

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

Inclusion Criteria: Adult patients admitted for an elective vascular surgery on abdominal aorta that agree and give written consent to be included in the study. Exclusion Criteria: Patients allergic to the drugs we will use in the study, local anaesthetic, nonopioid analgesics, NSAIDs. Patients with pain syndromes that are preoperatively already on any kind of chronic pain therapy. Patients that will experience surgical complications that requires reoperation will be excluded postoperatively.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    ropivacaine

    normal saline

    Arm Description

    Participants in this group will receive TAP block with 0,75%, bilaterally.

    Participants in this group will receive TAP block with normal saline, bilaterally.

    Outcomes

    Primary Outcome Measures

    Cumulative dose of opioid in the first 48 hours after surgery
    Cumulative dose of opioid, administered in the first 48 hours after surgery

    Secondary Outcome Measures

    Length of hospital stay
    Length of hospital stay after surgery measured in days
    Patient satisfaction with pain relief
    The participants will be asked to grade their satisfaction of pain relief on a 5 rating satisfaction scale from 1 - 5 (where 1 is best and 5 is worst). 1.very satisfied 2.satisfied 3. neither satisfied nor dissatisfied 4.dissatisfied 5. very dissatisfied
    Return of peristalsis
    Return of peristalsis after surgery measured in days

    Full Information

    First Posted
    April 23, 2023
    Last Updated
    June 4, 2023
    Sponsor
    University Medical Centre Ljubljana
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05860452
    Brief Title
    Effectiveness of TAP (Transversus Abdominis Plane) Block for Abdominal Aortic Surgery
    Official Title
    Effectiveness of TAP (Transversus Abdominis Plane) Block for Postoperative Pain Relief After Abdominal Aortic Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    February 2024 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Medical Centre Ljubljana

    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
    The goal of this study is to learn about the effectiveness of TAP block for pain relief after vascular surgery on the abdominal aorta. The main question the investigators are looking to answer is whether the TAP block lowers the dose of opioid required after abdominal aortic surgery.
    Detailed Description
    The surgery on the abdominal aorta requires extended haemodynamic monitoring and is performed under general anaesthesia. After applying general anaesthesia, the patients will receive a TAP block (subcostal approach) before the start of the surgery. During the procedure the patients will receive both opioid and nonopioid analgesics, as part of the standard perioperative protocol for abdominal aortic surgery. After the procedure all patients will receive following the standard protocol for pain relief after abdominal aortic surgery - NSAIDs and nonopioid analgesics regularly. All patients will postoperatively receive opioid as a rescue drug as needed (PCA). Participants will be randomly allocated in two groups, where one group will receive local anaesthetic for the TAP block and the control group will receive normal saline for the TAP block. The anaesthetist, the nurses and doctors in the postoperative care will all be blinded as to the group in which each patient is allocated. The participants will be followed from surgery until discharge from hospital.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Abdominal Aortic Aneurysm, Abdominal Aortic Stenosis, Syndrome, Leriche
    Keywords
    Abdominal aorta, TAP

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Dedicated anaesthetic nurse will prepare the syringes for administering the TAP block for each participant. She will be the only person to know which group each participant has been allocated to. Since local anaesthetic and normal saline have no color the anaesthetist performing the block will be, as will the doctors and nurses in postoperative care, blinded to the group each participant has been allocated to.
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ropivacaine
    Arm Type
    Active Comparator
    Arm Description
    Participants in this group will receive TAP block with 0,75%, bilaterally.
    Arm Title
    normal saline
    Arm Type
    Placebo Comparator
    Arm Description
    Participants in this group will receive TAP block with normal saline, bilaterally.
    Intervention Type
    Other
    Intervention Name(s)
    ropivacaine
    Intervention Description
    single shot bilateral TAP block
    Intervention Type
    Other
    Intervention Name(s)
    normal saline
    Intervention Description
    single shot bilateral TAP block
    Primary Outcome Measure Information:
    Title
    Cumulative dose of opioid in the first 48 hours after surgery
    Description
    Cumulative dose of opioid, administered in the first 48 hours after surgery
    Time Frame
    48 hours after surgery
    Secondary Outcome Measure Information:
    Title
    Length of hospital stay
    Description
    Length of hospital stay after surgery measured in days
    Time Frame
    up to 2 weeks
    Title
    Patient satisfaction with pain relief
    Description
    The participants will be asked to grade their satisfaction of pain relief on a 5 rating satisfaction scale from 1 - 5 (where 1 is best and 5 is worst). 1.very satisfied 2.satisfied 3. neither satisfied nor dissatisfied 4.dissatisfied 5. very dissatisfied
    Time Frame
    up to 7 days postoperatively
    Title
    Return of peristalsis
    Description
    Return of peristalsis after surgery measured in days
    Time Frame
    up to 2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients admitted for an elective vascular surgery on abdominal aorta that agree and give written consent to be included in the study. Exclusion Criteria: Patients allergic to the drugs we will use in the study, local anaesthetic, nonopioid analgesics, NSAIDs. Patients with pain syndromes that are preoperatively already on any kind of chronic pain therapy. Patients that will experience surgical complications that requires reoperation will be excluded postoperatively.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gordan Mijovski, MD
    Phone
    +38615223810
    Email
    gordan.mijovski@kclj.si
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gordan Mijovski, MD
    Organizational Affiliation
    UMC Ljubljana
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effectiveness of TAP (Transversus Abdominis Plane) Block for Abdominal Aortic Surgery

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