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Trunks Body Blocks for Postoperative Analgesia in Abdominal Surgery

Primary Purpose

Analgesia, Block

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
trunk blocks
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Analgesia focused on measuring quadratus lumborum block, transversus abdominis block, postoperative analgesia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Abdominal surgery

Exclusion Criteria:

Cardio-respiratory disease Anti-inflammatory treatment Cognitive disorders Written consent form haven't get history of relevant drug allergy infection of the skin at the site of the needle puncture area coagulopathy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Groups Q

    Groups T

    Groups C

    Arm Description

    In abdominal surgeries, USG guided Quadratus Lumborum 2 blocks are performed for postoperative analgesia. For this purpose, Quadratus Lumborum Block 2 (QLB 2) are frequently used blocks. The aim to this study was to evaluate the postoperative analgesia of preoperative trunk blocks, intraoperative hemodynamic changes with the unblocked control group, Modified Aldrete Recovery Score (MADS) 9 in the recovery unit, Numerical pain scale (NRS) in the service department, It is aimed to examine and compare the time it reaches on the 1st, 2nd and 24th hours after this period. Patient satisfaction is also evaluated in the ward.

    In abdominal surgeries, USG guided TAP blocks are performed for postoperative analgesia. For this purpose, TAP blocks are frequently used blocks. The aim to this study was to evaluate the postoperative analgesia of preoperative trunk blocks, intraoperative hemodynamic changes with the unblocked control group, Modified Aldrete Recovery Score (MADS) 9 in the recovery unit, Numerical pain scale (NRS) in the service department, It is aimed to examine and compare the time it reaches on the 1st, 2nd and 24th hours after this period. Patient satisfaction is also evaluated in the ward.

    There was no intervention. All patients will receive pre-oxygenation with O2 100% for 3 min. Anesthesia will be induced by using fentanyl 1μg/kg, propofol 1.5-2 mg/kg, and atracurium 0.5 mg/kg will be used for muscle relaxation. Anesthesia will be maintained by controlled ventilation with oxygen and air (50:50) with the target of EtCO2≈ 35-40 mmHg, isoflurane 1:1.5 minimum alveolar concentration (MAC). Anesthesia will be discontinued and tracheal extubation will be done once the patient fulfills the extubation criteria.Tramadol 100 mg i.v. Before 15 min end of surgery. The patient control analgesia device will administer all patients.

    Outcomes

    Primary Outcome Measures

    Postoperative pain
    The degree of pain will be measured with a numerical rating scale (NRS). All patients' postoperative pain logarithmic rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
    Postoperative pain
    The degree of pain will be measured with numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
    Postoperative pain
    The degree of pain will be measured with numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
    The degree of postoperative pain
    The degree of pain will be measured with a numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 23, 2019
    Last Updated
    April 21, 2020
    Sponsor
    Diskapi Teaching and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04143542
    Brief Title
    Trunks Body Blocks for Postoperative Analgesia in Abdominal Surgery
    Official Title
    Comparison of Quadratus Lumborum Block 2 and Transversus Abdominis Plan Block for Postoperative Analgesia in Abdominal Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 23, 2020 (Anticipated)
    Primary Completion Date
    May 1, 2020 (Anticipated)
    Study Completion Date
    May 5, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Diskapi Teaching and Research 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
    This study aims to the comparison of Quadratus Lumborum Block 2 and Transversus Abdominis Plan Block for Postoperative Analgesia in Abdominal Surgery
    Detailed Description
    This study aims to the comparison of Quadratus Lumborum Block 2 and Transversus Abdominis Plan Block for Postoperative Analgesia in Abdominal Surgery. In abdominal surgeries, USG guided body blocks are performed for postoperative analgesia. For this purpose, Transversus Abdominis Plan Block (TAPB) and Quadratus Lumborum Block 2 (QLB 2) are frequently used blocks. The aim of this study was to evaluate for postoperative analgesia of preoperative trunk blocks, intraoperative hemodynamic changes with the unblocked control group, Modified Aldrete Recovery Score (MADS) 9 in the recovery unit, Numerical pain scale (NRS) in the service department, It is aimed to examine and compare the time it reaches on the 1st, 2nd and 24th hours after this period. Patient satisfaction is also evaluated in the ward.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Analgesia, Block
    Keywords
    quadratus lumborum block, transversus abdominis block, postoperative analgesia

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Groups Q
    Arm Type
    Experimental
    Arm Description
    In abdominal surgeries, USG guided Quadratus Lumborum 2 blocks are performed for postoperative analgesia. For this purpose, Quadratus Lumborum Block 2 (QLB 2) are frequently used blocks. The aim to this study was to evaluate the postoperative analgesia of preoperative trunk blocks, intraoperative hemodynamic changes with the unblocked control group, Modified Aldrete Recovery Score (MADS) 9 in the recovery unit, Numerical pain scale (NRS) in the service department, It is aimed to examine and compare the time it reaches on the 1st, 2nd and 24th hours after this period. Patient satisfaction is also evaluated in the ward.
    Arm Title
    Groups T
    Arm Type
    Experimental
    Arm Description
    In abdominal surgeries, USG guided TAP blocks are performed for postoperative analgesia. For this purpose, TAP blocks are frequently used blocks. The aim to this study was to evaluate the postoperative analgesia of preoperative trunk blocks, intraoperative hemodynamic changes with the unblocked control group, Modified Aldrete Recovery Score (MADS) 9 in the recovery unit, Numerical pain scale (NRS) in the service department, It is aimed to examine and compare the time it reaches on the 1st, 2nd and 24th hours after this period. Patient satisfaction is also evaluated in the ward.
    Arm Title
    Groups C
    Arm Type
    No Intervention
    Arm Description
    There was no intervention. All patients will receive pre-oxygenation with O2 100% for 3 min. Anesthesia will be induced by using fentanyl 1μg/kg, propofol 1.5-2 mg/kg, and atracurium 0.5 mg/kg will be used for muscle relaxation. Anesthesia will be maintained by controlled ventilation with oxygen and air (50:50) with the target of EtCO2≈ 35-40 mmHg, isoflurane 1:1.5 minimum alveolar concentration (MAC). Anesthesia will be discontinued and tracheal extubation will be done once the patient fulfills the extubation criteria.Tramadol 100 mg i.v. Before 15 min end of surgery. The patient control analgesia device will administer all patients.
    Intervention Type
    Procedure
    Intervention Name(s)
    trunk blocks
    Intervention Description
    Comparison of trunks blocks and control groups for Postoperative Analgesia in Abdominal Surgery
    Primary Outcome Measure Information:
    Title
    Postoperative pain
    Description
    The degree of pain will be measured with a numerical rating scale (NRS). All patients' postoperative pain logarithmic rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
    Time Frame
    1 hours
    Title
    Postoperative pain
    Description
    The degree of pain will be measured with numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
    Time Frame
    2 hours
    Title
    Postoperative pain
    Description
    The degree of pain will be measured with numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
    Time Frame
    4 hours
    Title
    The degree of postoperative pain
    Description
    The degree of pain will be measured with a numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Abdominal surgery Exclusion Criteria: Cardio-respiratory disease Anti-inflammatory treatment Cognitive disorders Written consent form haven't get history of relevant drug allergy infection of the skin at the site of the needle puncture area coagulopathy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ceyda Ozhan Caparlar, MD
    Phone
    +905052919489
    Email
    mdceydacaparlar@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ceyda Ozhan Caparlar
    Organizational Affiliation
    Diskapi Yildirim Beyazit Education and Research Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Trunks Body Blocks for Postoperative Analgesia in Abdominal Surgery

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