Transversus Abdominis Plane Block Versus Quoadratus Lumborum Block on Infants

June 15, 2021 updated by: Pinar Ay Sayin, Sisli Hamidiye Etfal Training and Research Hospital

Comparison of Postoperative Analgesic Efficiency of Transversus Abdominis Plane Block and Quoadratus Lumborum Block on Infants Who Underwent Single Sided Inguinal Hernia Repair: A Randomised Controlled Trial

we aimed to compare the effects of TAPB and QLB on postoperative pain score and analgesic consumption in infants who underwent unilateral inguinal hernia surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Infants are more sensitive to the side effects of general anesthesia than older children. This may be associated with the incomplete maturation of organ systems effective in pharmacodynamics. Regional anesthesia applications provide safe and effective analgesia by reducing the need for opioids. Regional anesthesia applications in infants require experience and complication rates due to central blocks are high. However, in recent years, the use of ultrasound (USG) has increased the use of safe and effective trunk blocks. There are studies on the use of Transversus Abdominis Plan Block (TAPB) and Quadratus Lumborum Block (QLB) in children. However, there is no comparative study on its use in infants.

In our study, we aimed to compare the effects of TAPB and QLB on postoperative pain score and analgesic consumption in infants who underwent unilateral inguinal hernia surgery.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34371
        • Recruiting
        • Sisli etfal research and training hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1 month to 1 year
  • who were scheduled for unilateral inguinal hernia operation
  • American Society of Anesthesiologists (ASA) physical score I-II

Exclusion Criteria:

  • Patients with ASA II-IV
  • coagulopathy
  • skin infection at the block application site
  • bupivacaine allergy
  • bilateral inguinal hernia operation
  • additional operation in different region
  • laparoscopic inguinal hernia operation
  • younger than 1 month
  • with a history of prematurity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: transversus abdominis plane
In the group in which Transversus Abdominis Plan Block was applied, the patient was placed in the supine position. After skin antisepsis was achieved with 10% povidone iodine, the USG probe was placed transversely between the iliac crest and the anterolateral abdominal wall. After visualizing the external-internal obliq and transversus abdominis muscles, 0.5 ml/kg of 0.25% bupivacaine was injected after negative aspiration by advancing the needle into the fascia between the internal obliq muscle and the transversus abdominis muscle with the in-plane technique.
Procedure: transversus abdominis plane block
The transversus abdominis plane (TAP) block was first introduced by Rafi et al. in 2001 as a landmark-guided technique via the triangle of Petit to achieve a field block. It involves the injection of a local anesthetic solution into a plane between the internal oblique muscle and transversus abdominis muscle. Since the thoracolumbar nerves originating from the T6 to L1 spinal roots run into this plane and supply sensory nerves to the anterolateral abdominal wall , the local anesthetic spread in this plane can block the neural afferents and provide analgesia to the anterolateral abdominal wall.
Other Names:
  • quoadratus lumborum block
Active Comparator: quoadratus lumborum block
In the Quadratus Lumborum Block (Lateral approach) group, the patient was placed in the lateral position with the side to be blocked on top. After skin antisepsis was achieved with 10% povidone iodine, the USG probe was placed transversely between the iliac crest and costa edge. After visualizing the extarnal-internal obliq and transversus abdominis muscles, the probe was advanced posteriorly. Quadratus lumborum muscle and thoracolumbar fascia were visualized. The needle was advanced to the anterolateral border of the quadratus lumborum muscle with the in-plane technique and 0.5 ml/kg of 0.25% bupivacaine was injected after negative aspiration.
Procedure: quoadratus lumborum block
quoadratus lumborum block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FLACC
Time Frame: up to 24 hours
Face, Legs, Activitiy, Cry, Consolability score
up to 24 hours
first analgesic need times
Time Frame: up to 24 hours
time of first analgesic need after surgery
up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
frequency of need for analgesics
Time Frame: up to 24 hours
Frequency of analgesic requirement in the first 24 hours after the operation
up to 24 hours
complications
Time Frame: up to 24 hours
post-operative anesthetic complications
up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

October 15, 2021

Study Registration Dates

First Submitted

June 9, 2021

First Submitted That Met QC Criteria

June 15, 2021

First Posted (Actual)

June 16, 2021

Study Record Updates

Last Update Posted (Actual)

June 16, 2021

Last Update Submitted That Met QC Criteria

June 15, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 33334

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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