NCT04094987

Brief Summary

The block has been shown to be the result of abdominal analgesia as a result of application between the quadratus lumborum (QL) muscle and the leaves in the thoracolumbar fascia. In this block, local anesthetic drugs are administered between the quadratus lumborum (QL) muscle and the anterior leaf in the thoracolumbar fascia. In this way, it has been reported that it provides a good analgesia as it relieves somatic pain better in upper and lower abdominal surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 11, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

September 29, 2019

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2020

Completed
Last Updated

February 2, 2021

Status Verified

February 1, 2021

Enrollment Period

16 days

First QC Date

September 11, 2019

Last Update Submit

February 1, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Interfascial Pressure (mm/hg)

    İnterfascial pressure will be measured the postoperative 24. hours through catheter.

    24 hours.

Secondary Outcomes (3)

  • sensory block level

    peroperative 3 hours

  • Visual Analog Scale

    Postoperative 24 hours

  • analgesic use

    Postoperative 24 hours

Study Arms (1)

Quadratus Lumborum block

EXPERIMENTAL

We will use the ultrasound guided anterior Quadratus Lumborum Block.A peripheral nerve block catheter will be placed between the quadratus lumborum muscle and the psoas muscle with ultrasound

Device: inter-fascial pressure

Interventions

The pressure between the fascia and the pressure line added to the catheter tip will be measured.

Quadratus Lumborum block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who were in the American Society of Anesthesiologists (ASA) I-III class
  • Underwent laparoscopic cholecystectomy

You may not qualify if:

  • Previous history of preoperative opioid use,
  • Allergy to local anesthetics,
  • The presence of any systemic infection,
  • Uncontrolled arterial hypertension,
  • Uncontrolled diabetes mellitus
  • Presence of infection in the block area,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Korgün Ökmen

    Bursa Yuksek Ihtisas Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: prospective, cohort
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 11, 2019

First Posted

September 19, 2019

Study Start

September 29, 2019

Primary Completion

October 15, 2019

Study Completion

September 15, 2020

Last Updated

February 2, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations