Quadratus Lumborum Block : Local Anesthesia Versus Placebo

NCT ID: NCT03411096

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-08

Study Completion Date

2024-12-31

Brief Summary

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Opioid analgesics have many side effects. Quadratus lumborum (QL) block is one kind of regional nerve block that can reduce the side effects of opioid analgesics. The investigators hypothesize that QL block with local analgesics (ropivacaine) can significantly reduce pain intensity in comparison with placebo.

Detailed Description

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Opioid analgesics have been used to control the pain. However, many postoperative complication, such as nausea, vomiting, constipation, ileus, etc are related to opioid usage. Recently, local or regional pain nerve block, such as transversus abdominis plane block, wound infiltration, have been reported in several studies. Quadratus lumborum (QL) block was first introduced in the abstract of 2007 European Society of Regional Anesthesia. The effect is longer and more than that of transversus abdominis plane block because it works close to the spinal cord nerves. The QL block can be an effective pain control method for patients who underwent ileostomy closure. The aim of this study is to compare pain intensity after ileostomy closure between QL block (ropivacaine) group and placebo group (normal saline).

Conditions

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Loop Ileostomy Colorectal Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Quadratus lumborum block

Quadratus lumborum block with 0.75% ropivacaine

Group Type EXPERIMENTAL

Quadratus lumborum block using ropivacaine

Intervention Type PROCEDURE

After general anesthesia, an anesthesiologist will perform an quadratus lumborum block with 0.75% ropivacaine (20cc) under ultrasound guidance.

Placebo

Quadratus lumborum block with normal saline

Group Type PLACEBO_COMPARATOR

Quadratus lumborum block with normal saline

Intervention Type PROCEDURE

After general anesthesia, an anesthesiologist will perform an quadratus lumborum block with normal saline (20cc) under ultrasound guidance.

Interventions

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Quadratus lumborum block using ropivacaine

After general anesthesia, an anesthesiologist will perform an quadratus lumborum block with 0.75% ropivacaine (20cc) under ultrasound guidance.

Intervention Type PROCEDURE

Quadratus lumborum block with normal saline

After general anesthesia, an anesthesiologist will perform an quadratus lumborum block with normal saline (20cc) under ultrasound guidance.

Intervention Type PROCEDURE

Other Intervention Names

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Quadratus lumborum block

Eligibility Criteria

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Inclusion Criteria

* Aged 20-75 years, either sex
* Patients scheduled to undergo elective ileostomy repair surgery under general anesthesia.
* Patients underwent curative surgery and ileostomy due to colorectal cancer.
* Willingness and ability to sign an informed consent document

Exclusion Criteria

* Allergies to anesthetic or analgesic medications
* Contraindication to the use of locoregional anesthesia
* Chronic opioid use
* Coagulopathy, Impaired kidney function, uncontrolled diabetes, psychiatric disorders, severe cardiovascular impairment or chronic obstructive lung disease
* Necessity of major resection other than colorectal, palliative surgery
* BMI above 35kg/m2
* American Society of Anesthesiologists (ASA) physical status above 3
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyungpook National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo Yeun Park

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin Seok Yeo, MD

Role: STUDY_DIRECTOR

Kyungpook National University Chilgok Hospital

In Teak Woo, MD

Role: STUDY_CHAIR

Kyungpook National University Chilgok Hospital

Soo Yeun Park, MD

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Locations

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Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KNUHC02

Identifier Type: -

Identifier Source: org_study_id

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