Quadratus Lumborum Block : Local Anesthesia Versus Placebo

March 3, 2025 updated by: Soo Yeun Park, Kyungpook National University Hospital

Comparison of Analgesic Efficacy of Quadratus Lumborum Block With Local Anesthesia and Quadratus Lumborum Block With Placebo Only After Ileostomy Repair: a Randomized, Double-blind, Non-inferiority Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 41404
        • Kyungpook National University Chilgok Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Quadratus lumborum block
Quadratus lumborum block with 0.75% ropivacaine
Procedure: Quadratus lumborum block using ropivacaine
After general anesthesia, an anesthesiologist will perform an quadratus lumborum block with 0.75% ropivacaine (20cc) under ultrasound guidance.
Other Names:
  • Quadratus lumborum block
Placebo Comparator: Placebo
Quadratus lumborum block with normal saline
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain numerical rating scale (NRS)
Time Frame: 6 hours after surgery
  1. Pain NRS during rest and cough
  2. NRS scale 0-10:0, "no pain"; 10, "worst pain imaginable"
6 hours after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain NRS
Time Frame: 2, 12,24,36,48,72 hour after surgery
  1. Pain NRS during rest and cough
  2. NRS scale 0-10:0, "no pain"; 10, "worst pain imaginable"
2, 12,24,36,48,72 hour after surgery
Rescue opioid analgesic requirement
Time Frame: postoperative day 0,1,2,3
Overall postoperative rescue of opioid analgesic requirement described by using the Defined Daily Dose
postoperative day 0,1,2,3
Postoperative nausea and vomiting scale
Time Frame: 2, 12,24,36,48,72 hour after surgery
Postoperative nausea and vomiting scores (assessed using a 0-2 categorical scale; no nausea/nausea/vomiting)
2, 12,24,36,48,72 hour after surgery
Occurrence of prolonged post-operative ileus
Time Frame: 8 weeks after surgery
Occurrence of prolonged post-operative ileus (assessed using a 0-1 categorical scale; no ileus/ ileus)
8 weeks after surgery
Time to first oral fluid intake
Time Frame: 8 weeks after surgery
Time to first oral fluid intake after surgery
8 weeks after surgery
Time to first oral soft diet
Time Frame: 8 weeks after surgery
Time to first oral soft diet after surgery
8 weeks after surgery
Length of hospital stay
Time Frame: 8 weeks after surgery
Length of hospital stay after admission
8 weeks after surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kyungpook National University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jin Seok Yeo, MD, Kyungpook National University Chilgok Hospital
  • Study Chair: In Teak Woo, MD, Kyungpook National University Chilgok Hospital
  • Principal Investigator: Soo Yeun Park, MD, Kyungpook National University 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KNUHC02

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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