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Comparison of Thoracolumbar Interfascial and Erector Spinae Plane Block on Analgesic Efficiency of After Spinal Surgery (TALIPES)

Primary Purpose

Postoperative Pain, Postoperative Nausea and Vomiting, Opioid Use

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance
Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Thoracolumbar interfascial block, Erector spinae plane block

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 20-75 years
  2. ASA 1-2-3
  3. Patients scheduled for elective surgery

Exclusion Criteria:

  1. Patients with previous neurological disease symptoms (TIA, syncope, dementia, etc.)
  2. Allergy to drugs
  3. Major cardiac disease
  4. Renal failure
  5. Psychiatric disease
  6. Patients who refuse to participate in the study
  7. Chronic back and lower back pain

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Thoracolumbar interfascial plane block

    Erectro spinae plane block

    Arm Description

    Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance

    Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance

    Outcomes

    Primary Outcome Measures

    Total morphine consumption
    The total amount of morphine given by patient controlled analgesia in 48 hours will be recorded.

    Secondary Outcome Measures

    Pain intensity score at rest
    Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at postoperative 1, 3, 6, 12, 24, 48 hour. he NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of patient pain. Each item is scored 0-10( 0:no pain 10: pain as bad as can be )
    Pain intensity score at movement
    Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at postoperative 1, 3, 6, 12, 24, 48 hour. he NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of patient pain. Each item is scored 0-10( 0:no pain 10: pain as bad as can be )
    Time to first rescue analgesia
    If VAS is greater than 3, 25 mg of meperidine will be administered.
    Postoperative nausea and vomiting
    Changes in Numeric Rank Score will be recorded at postoperative 1, 3, 6, 12, 24, 48 hour. Numeric rank score 0-3(0: no nausea and vomiting; 1:have nausea, no vomiting; 2:once vomiting attack; 3: have two or more vomiting attacks)
    Patient satisfaction score
    Will be scored between 1-5 (1- very bad 5-very good).

    Full Information

    First Posted
    April 26, 2019
    Last Updated
    October 7, 2020
    Sponsor
    Bezmialem Vakif University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03931343
    Brief Title
    Comparison of Thoracolumbar Interfascial and Erector Spinae Plane Block on Analgesic Efficiency of After Spinal Surgery
    Acronym
    TALIPES
    Official Title
    Randomized, Double Blind Trial of Thoracolumbar Interfascial Plane Block and Erector Spinae Plane Block for Adult Spinal Surgery
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bezmialem Vakif University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Spinal surgery is typically associated with severe postoperative pain. Although the number of spinal surgeries has increased day by day, postoperative pain management have been limited. The recently described thoracolumbar interfacial plane block (TLIPB) has been reported to provide effective postoperative analgesia in spinal surgery. In addition, the recently described erector spinae plane block (ESPB) is obtained by applying the local anesthetic drug between the fascia of the spina muscles and the transverse process of the vertebrae. Anatomical and radiological investigations in fresh cadavers suggest that the potential place of influence of ESPB is dorsal and ventral spinal nerve roots. A small number of publications showing the analgesic efficacy of ESP in spinal surgery have been reported in the literature. In this study, the investigators aimed to compare the analgesic efficacy of TLIPB and ESPB in spinal surgeries.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain, Postoperative Nausea and Vomiting, Opioid Use
    Keywords
    Thoracolumbar interfascial block, Erector spinae plane block

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Thoracolumbar interfascial plane block
    Arm Type
    Experimental
    Arm Description
    Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance
    Arm Title
    Erectro spinae plane block
    Arm Type
    Active Comparator
    Arm Description
    Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance
    Intervention Type
    Procedure
    Intervention Name(s)
    Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance
    Other Intervention Name(s)
    Thoracolumbar interfascial plane block
    Intervention Description
    Thoracolumbar interfascial plane block: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance
    Intervention Type
    Procedure
    Intervention Name(s)
    Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance
    Other Intervention Name(s)
    Erector spinae plane block
    Intervention Description
    Erector spinae plane block: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance
    Primary Outcome Measure Information:
    Title
    Total morphine consumption
    Description
    The total amount of morphine given by patient controlled analgesia in 48 hours will be recorded.
    Time Frame
    48 hour
    Secondary Outcome Measure Information:
    Title
    Pain intensity score at rest
    Description
    Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at postoperative 1, 3, 6, 12, 24, 48 hour. he NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of patient pain. Each item is scored 0-10( 0:no pain 10: pain as bad as can be )
    Time Frame
    48 hour
    Title
    Pain intensity score at movement
    Description
    Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at postoperative 1, 3, 6, 12, 24, 48 hour. he NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of patient pain. Each item is scored 0-10( 0:no pain 10: pain as bad as can be )
    Time Frame
    48 hour
    Title
    Time to first rescue analgesia
    Description
    If VAS is greater than 3, 25 mg of meperidine will be administered.
    Time Frame
    48 hour
    Title
    Postoperative nausea and vomiting
    Description
    Changes in Numeric Rank Score will be recorded at postoperative 1, 3, 6, 12, 24, 48 hour. Numeric rank score 0-3(0: no nausea and vomiting; 1:have nausea, no vomiting; 2:once vomiting attack; 3: have two or more vomiting attacks)
    Time Frame
    48 hour
    Title
    Patient satisfaction score
    Description
    Will be scored between 1-5 (1- very bad 5-very good).
    Time Frame
    48 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 20-75 years ASA 1-2-3 Patients scheduled for elective surgery Exclusion Criteria: Patients with previous neurological disease symptoms (TIA, syncope, dementia, etc.) Allergy to drugs Major cardiac disease Renal failure Psychiatric disease Patients who refuse to participate in the study Chronic back and lower back pain
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Serdar Yeşiltaş
    Phone
    +905423632630
    Email
    syesiltas@bezmialem.edu.tr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sinan Yılmaz
    Phone
    +905324563023
    Email
    syilmaz@bezmialem.edu.tr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Serdar Yeşiltaş
    Organizational Affiliation
    Bezmialem Vakif University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Comparison of Thoracolumbar Interfascial and Erector Spinae Plane Block on Analgesic Efficiency of After Spinal Surgery

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