NCT04927624

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2021

Completed
Last Updated

June 16, 2021

Status Verified

June 1, 2021

Enrollment Period

4 months

First QC Date

June 9, 2021

Last Update Submit

June 15, 2021

Conditions

Transversus Abdominis Plane BlockQuoadratus Lumborum Block

Keywords

infantanalgesic efficiencyRegional anesthesia

Outcome Measures

Primary Outcomes (2)

  • FLACC

    Face, Legs, Activitiy, Cry, Consolability score

    up to 24 hours

  • first analgesic need times

    time of first analgesic need after surgery

    up to 24 hours

Secondary Outcomes (2)

  • frequency of need for analgesics

    up to 24 hours

  • complications

    up to 24 hours

Study Arms (2)

transversus abdominis plane

ACTIVE COMPARATOR

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

quoadratus lumborum block

ACTIVE COMPARATOR

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

Interventions

transversus abdominis plane blockPROCEDURE

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.

Also known as: quoadratus lumborum block
transversus abdominis plane
quoadratus lumborum blockPROCEDURE

quoadratus lumborum block

quoadratus lumborum block

Eligibility Criteria

Age1 Month - 12 Months
Sexall(Gender-based eligibility)
Gender Eligibility Detailsinfants
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sisli Etfal Research and Training Hospital

Istanbul, 34371, Turkey (Türkiye)

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist medical doctor

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 16, 2021

Study Start

June 1, 2021

Primary Completion

September 30, 2021

Study Completion

October 15, 2021

Last Updated

June 16, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)