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TAP Block On Abdominal Surgery Patients With General Anesthesia (TAPBLOCK)

Primary Purpose

Post-Op Complication, Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transversus abdominis plane (TAP) block
Sponsored by
Cumhuriyet University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Post-Op Complication focused on measuring TAP block, postoperative pain, Bupivacaine, ultra sound guided regional anesthesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 1) ASA I and II patients. 2) Healthy people.

Exclusion Criteria: 1)Those with skin infections, 2) Patients with organomegaly (hepatomegaly and splenomegaly), 3) People who did not give consent to the method. 4) Individuals with allergies to drugs to be used in the intervention area where Transversus abdominis plane is to be conducted were not included in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Tap block Group

    Control Group

    Arm Description

    Tap Block group :(Group 1) After General anestehesia At the end of the operation, TAP blocks were placed to the 1st group patients.

    No block applied. only General anesthesia was applied.

    Outcomes

    Primary Outcome Measures

    Visual Analog Scale of patients
    Pain scale
    Sistolic Blood Pressure of patients
    Sistolic Blood Pressure
    Need For Analgesic drugs for post-op patients
    Analgesic need
    patients with nausea
    post op nausea

    Secondary Outcome Measures

    Full Information

    First Posted
    April 23, 2020
    Last Updated
    April 25, 2020
    Sponsor
    Cumhuriyet University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04364477
    Brief Title
    TAP Block On Abdominal Surgery Patients With General Anesthesia
    Acronym
    TAPBLOCK
    Official Title
    The Effect Of The Transversus Abdominis Plane Block On Postoperative Analgesia and Patient Comfort In Patients Having Abdominal Surgery With General Anesthesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 4, 2015 (Actual)
    Primary Completion Date
    January 4, 2016 (Actual)
    Study Completion Date
    February 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cumhuriyet University Hospital

    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
    INTRODUCTION: The aim of this study was to investigate the effects of tranversus abdominis plane (TAP) block placed postoperatively using ultrasound guidance for patients with caesarean section, myomectomy and hysterectomy under general anesthesia by eliminating additional pain caused by surgical incision. MATERIALS AND METHODS: The study has been planned to investigate the postoperative analgesia of 50 patients with TAP blocks applied and non-applied between the ages of 18-65, who will pass abdominal surgery. Study has been conducted in a prospective, randomized and controlled manner. Patients have been classified as those who have undergone TAP block (group: I) and those without block (group: II).
    Detailed Description
    The study was conducted in accordance with the Helsinki Declaration Principles (rev.2013) and with the approval of the local ethical board. After the written and signed approval of the patients, it has been planned to investigate the postoperative analgesia and comfort of a total of 50 patients The study examined the postoperative pain levels after abdominal surgery with and without TAP block. Subjects were between the ages of 18-65 who will have abdominal surgery with transverse incision (cesarean section, hysterectomy (benign), myomectomy) and American Society of Anesthesiologists Physical Status Classification System (ASA) I-II. Our study is planned to be prospective, randomized and controlled. The individuals to be engaged were divided into two groups in a randomized form. Randomization was based on a computer-generated code. In the first group, a total of 25 patients were admitted with 16 cesareans, 6 myomectomies and 3 hysterectomies applied to the TAP block. In the second group, a total of 25 patients who did not undergo TAP block, no needle intervention, 18 cesareans, 5 myomectomies and 2 hysterectomies were included as the control group. Those with skin infections, patients with organomegaly (hepatomegaly and splenomegaly), people who did not give consent to the method, and individuals with allergies to drugs to be used in the intervention area where Transversus abdominis plane is to be conducted were not included in the study. Isolyte® balanced electrolyte solution at a rate of 2 ml/kg/hour was administered to the individuals whose oral intake was discontinued 8 hours before the surgery. The individuals to be included in the study were not given any sedative agent on the morning of their surgery. 10 cm visual analog scale (VAS) was explained in detail to all patients before the procedure. All individuals to be included in the study were followed up with anesthesia monitor (Drager Infinity Vista XL®), heart rate (CAH), electrocardiography (ECG) (lead II), systolic blood pressure (SKB) and diastolic blood pressure (DBP) in the preoperative and preoperative period. After induction of anesthesia with 1 µg/kg fentanyl (Fentanyl, Janssen-Cilag), 0.5 mg/kg rocuronium bromide (Esmeron® vial, Schering-Plough) and 5 mg/kg thiopental sodium (Pental Sodium®, I.E Ulagay), 4-6% Desflurane (Suprane® Volatile Solution, Pharmacist-Head - Baxter) and 50% N2O in Oxygen were used to maintain anesthesia following endotracheal intubation. Differently in general anesthesia management at cesarean operations, 5 mg/kg thiopental sodium (Pental Sodium®, I.E Ulagay) and 0.5 mg/kg rocuronium bromide (Esmeron® vial, Schering-Plough) were administered in induction and 4-6% Desflurane (Suprane® Volatile Solution, Pharmaceutical-headed-Baxter), (50% N2O+50% Oxygen) and 1 µg/kg fentanyl (Fentanyl, Janssen-Cilag) are added as inhalation anesthesia after umbilical cord clamping in maintenance. The maintenance dose of rocuronium bromide was 0.15 mg/kg for all cases. Necessary fluid replacement was performed during the operation. At the end of the operation, TAP blocks were placed to the 1st group patients. After the necessary sterilization conditions were established, the linear ultrasound probe was sterilely coated and placed in the middle of the iliac crest with the end limit of the ribs. Starting with skin, the layers in descending order, subcutaneous adipose tissue, external oblique muscle, internal oblique muscle, transversus abdominis muscle and peritoneum were identified. As the tip of the 21Gx100 mm needle (Pajunk®-Uniplex Nanoline cannula with facet tip) passed through the muscular layers and fascia, a fascial click was felt and the needle was advanced with ultrasound in a controlled manner. After receiving the second click sensation (passage of the fascia of the internal oblique muscle), after a 0.5-1 ml test dose, the location of the needle was fixed and frequently aspirated and applied to the bilateral neurophysical plan so that 20 ml of 0.25% bupivacaine (Marcaine® 0.5%, Astra Zeneca) was applied to one side. The first group of patients were awakened after TAP block treatment and reversal of muscle relaxant with atropine sulphate and neostigmine; the control group was awakened after reversal of muscle relaxant with atropine sulphate and neostigmine at the end of the operation. When VAS>3 in the postoperative period, 1g of paracetamol was administered as an intravenous infusion over 10 minutes in terms of the first analgesic requirement. Systolic and diastolic arterial pressures, heart rate of all patients were monitored immediately before and postoperatively at 30th minute and 1st, 2nd, 4th, 6th, 12th and 24th hours after block administration. The pain levels of the patients were measured at the 30th minute, 1st, 2nd, 4th, 6th, 12th and 24th postoperative VAS values. The need for nausea, vomiting, and initial analgesia was recorded. In this study, none of the patients underwent any invasive procedures other than routine procedures. When parametric test counts were fulfilled (Kolmogorov-Simirnov) by uploading the data obtained from our study to SPSS (ver:22.0) program, significance test of the difference between the two averages, variance analysis in repeated measurements, Bonferroni test, Mann Whitney U test, Wilcoxon test, Freidman test and Chi-square test were used when parametric test assumptions were not fulfilled. When α is taken as 0.05, β: 0.10, 1-β: 0.90, 25 individuals were included in each group and the strength of the test was p= 0.90388. Our data were reported as arithmetic mean, standard deviation, number of individuals and the level of error was taken as 0.05.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-Op Complication, Pain, Postoperative
    Keywords
    TAP block, postoperative pain, Bupivacaine, ultra sound guided regional anesthesia

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tap block Group
    Arm Type
    Active Comparator
    Arm Description
    Tap Block group :(Group 1) After General anestehesia At the end of the operation, TAP blocks were placed to the 1st group patients.
    Arm Title
    Control Group
    Arm Type
    Placebo Comparator
    Arm Description
    No block applied. only General anesthesia was applied.
    Intervention Type
    Procedure
    Intervention Name(s)
    transversus abdominis plane (TAP) block
    Other Intervention Name(s)
    General Anesthesia
    Intervention Description
    The transversus abdominis plane (TAP) block is a regional anesthesia technique described in recent years that provides analgesia for the anterior portion of the abdominal wall after abdominal surgery.
    Primary Outcome Measure Information:
    Title
    Visual Analog Scale of patients
    Description
    Pain scale
    Time Frame
    0-30 minutes
    Title
    Sistolic Blood Pressure of patients
    Description
    Sistolic Blood Pressure
    Time Frame
    0-30 minutes
    Title
    Need For Analgesic drugs for post-op patients
    Description
    Analgesic need
    Time Frame
    0-60 minutes
    Title
    patients with nausea
    Description
    post op nausea
    Time Frame
    0-60 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 1) ASA I and II patients. 2) Healthy people. Exclusion Criteria: 1)Those with skin infections, 2) Patients with organomegaly (hepatomegaly and splenomegaly), 3) People who did not give consent to the method. 4) Individuals with allergies to drugs to be used in the intervention area where Transversus abdominis plane is to be conducted were not included in the study.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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