TFPB vs QLB III in Infra-umbilical Pediatric Surgeries

Sponsor
Namik Kemal University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05671484
Collaborator
(none)
66
1
2
6
11

Study Details

Study Description

Brief Summary

Regional anesthetic techniques; they reduce postoperative morbidity, provide early mobilization and provide great advantages by significantly reducing the need for narcotic analgesics. Regional anesthetic techniques are widely used in our clinic for postoperative analgesia, especially in infants and children. In patients undergoing lower abdominal surgery, postoperative analgesia is usually provided by systemic opioids and neuraxial methods. Complications such as sedation, respiratory depression, itching, nausea, vomiting and possible paraplegia or bleeding of neuraxial methods due to the use of opioids seem to be the biggest disadvantages of these two methods. Transversalis fascial plane (TFP) block is a regional anesthesia technique that provides intraoperative and postoperative analgesia as an alternative to caudal and epidural analgesia, especially in children. Transversalis fascial plane (TFP) block was first described in 2009. TFP block has been shown to be effective as an alternative to epidural analgesia and as part of a multimodal postoperative analgesic approach in lower abdominal and pelvic surgeries in children. Quadratus lumborum block (QLB) is a widely used regional anesthesia technique. It is used in pediatric patients to reduce postoperative pain in supraumbilical or infraumbilical surgeries. As a common result of all approaches, the main effect in quadratus lumborum block is anesthesia of the lateral cutaneous branches. In our center, the investigators have been using both methods, alone or in combination, routinely for a long time, and the investigators aim to compare the two methods in this study. This study consists of comparing two domain blocks known as part of multimodal analgesia.

Condition or Disease Intervention/Treatment Phase
  • Other: Transversalis Fascial Plane Block
  • Other: Quadratus Lumborum Plane Block
N/A

Detailed Description

Transversalis fascial plane block and quadratus lumborum block are performed under general anesthesia just before the surgical incision, unless there are contraindications for the procedure for every patient scheduled for elective infraumbilical surgery in our center. In our study, patients will be divided into 2 groups and the effectiveness of trunk plan blocks, which are part of multimodal analgesia, will be compared. In the first group there will be patients who underwent transversalis fascial plane block (TFPB) alone, and in the second group there will be patients who underwent type III quadratus lumborum block (QLB). Post-operative pain scores with the Face, Leg, Activity, Cry, Consolability (FLACC) score will be recorded in 2-6-12-24th hours. Between both groups, postoperative analgesia need, time of analgesia need, presence of nausea and vomiting, surgeon and parent satisfaction will be followed up and recorded. All patients are operated under general anesthesia. General anesthesia is maintained with inhalation anesthesia. At the end of the surgery, the patient is awakened and taken to the recovery unit. In this prospective randomized study, the investigators will compare the efficacy of these two blocks, which are part of multimodal analgesia, with postoperative analgesic consumption. Postoperative patient comfort, complications, demographic findings will be used as data.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The patients will be divided randomly by a computer-generated randomization table into two equal groups.The patients will be divided randomly by a computer-generated randomization table into two equal groups.
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Investigation of the Effects of Transversalis Fascial Plane Block and Quadratus Lumborum Plane Block Applied in Pediatric Infra-umbilical Surgeries on Postoperative Pain and Analgesic Consumption
Actual Study Start Date :
Dec 30, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Transversalis Fascial Plane Block Group

Patients will receive ultrasound-guided transversalis fascial plane block

Other: Transversalis Fascial Plane Block
Patients will receive ultrasound-guided transversalis fascial plane block with 0,3 ml/kg of bupivacaine 0.25% just after general anesthesia induction
Other Names:
  • TFPB
  • Active Comparator: Quadratus Lumborum Block Group

    Patients will receive ultrasound-guided quadratus lumborum block

    Other: Quadratus Lumborum Plane Block
    Patients will receive ultrasound-guided quadratus lumborum plane block with 0,3 ml/kg of bupivacaine 0.25% just after general anesthesia induction
    Other Names:
  • QLB III
  • Outcome Measures

    Primary Outcome Measures

    1. Total dose of paracetamol consumption [in the first 24 hour postoperatively]

      Total dose of paracetamol consumption in the ward

    Secondary Outcome Measures

    1. FLACC score [in the first 24 hour postoperatively]

      Postoperative FLACC score in the ward. FLACC score is a 10 point behavioral face, leg, activity, cry, consolability pain scale with a minimum score of 0 and a maximum of 10.

    2. The 1st time to rescue analgesic need [in the first 24 hour postoperatively]

      The time to ask for postoperative analgesia is the time from the end of operation to patient reporting FLACC score ≥ 4.

    3. Number of postoperative nausea and vomiting [in the first 24 hour postoperatively]

      Postoperative nausea and vomiting presence

    4. Parental satisfaction level [in the first 24 hour postoperatively]

      Parental satisfaction level will be evaluated using a five-point Likert scale 5= very satisfied 4= satisfied 3= neutral 2= dissatisfied 1= very dissatisfied

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 7 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Parental acceptation to participate and signed written consent

    • Aged between 3 and 7

    • American Society of Anesthesiologists (ASA) physical score I or II

    • Elective infra umbilical surgery

    Exclusion Criteria:
    • Parental refusal to participate

    • Known allergy to local anesthetics

    • American Society of Anesthesiologists (ASA) physical score ≥ III

    • Coagulopathy

    • Hypersensitivity history to the agents to be used

    • Local infections

    • Known anatomically or systemic disorder

    • Known growth and developmental retardation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tekirdag Namik Kemal University Tekirdağ Turkey

    Sponsors and Collaborators

    • Namik Kemal University

    Investigators

    • Study Chair: Onur Baran, Asst. Prof., Tekirdag Namik Kemal University
    • Principal Investigator: Ayhan Şahin, Asst. Prof., Tekirdag Namik Kemal University
    • Study Director: Cavidan Arar, Prof., Tekirdag Namik Kemal University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Onur Baran, Assistant Professor, Namik Kemal University
    ClinicalTrials.gov Identifier:
    NCT05671484
    Other Study ID Numbers:
    • 2022.205.11.06
    First Posted:
    Jan 4, 2023
    Last Update Posted:
    Jan 11, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Onur Baran, Assistant Professor, Namik Kemal University

    Study Results

    No Results Posted as of Jan 11, 2023