Loop IleostomyNCT03411096

Quadratus Lumborum Block : Local Anesthesia Versus Placebo

A study testing Quadratus lumborum block using ropivacaine and Quadratus lumborum block with normal saline in people with Loop Ileostomy and Colorectal Disorders, run by Kyungpook National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 20 to 75 years
Conditions the study is for: Loop Ileostomy, Colorectal Disorders
What is being tested?: Quadratus lumborum block using ropivacaine and Quadratus lumborum block with normal saline
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 57 participants
Where: 1 siteSouth Korea
Study dates: 8 Apr 2020to 31 Dec 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Kyungpook National University Chilgok Hospital
Daegu, 41404

Other trials in South Korea

About this study

Official title: 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

Read the 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).

Conditions: Loop Ileostomy, Colorectal Disorders
Being tested: Quadratus lumborum block using ropivacaine, Quadratus lumborum block with normal saline

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Quadratus lumborum block using ropivacaineProcedure or surgery
Also called Quadratus lumborum block
After general anesthesia, an anesthesiologist will perform an quadratus lumborum block with 0.75% ropivacaine (20cc) under ultrasound guidance.
Quadratus lumborum block with normal salineProcedure or surgery
After general anesthesia, an anesthesiologist will perform an quadratus lumborum block with normal saline (20cc) under ultrasound guidance.

Study groups in NCT03411096
Study group	Role	What they receive
Quadratus lumborum block	Experimental	Quadratus lumborum block with 0.75% ropivacaine Receives: Procedure: Quadratus lumborum block using ropivacaine
Placebo	Placebo comparator	Quadratus lumborum block with normal saline Receives: Procedure: Quadratus lumborum block with normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain numerical rating scale (NRS)
1. Pain NRS during rest and cough
2. NRS scale 0-10:0, "no pain"; 10, "worst pain imaginable"
Measured: 6 hours after surgery

Secondary outcomes (7)

Pain NRS
1. Pain NRS during rest and cough
2. NRS scale 0-10:0, "no pain"; 10, "worst pain imaginable"
Measured: 2, 12,24,36,48,72 hour after surgery
Rescue opioid analgesic requirement
Overall postoperative rescue of opioid analgesic requirement described by using the Defined Daily Dose
Measured: postoperative day 0,1,2,3
Postoperative nausea and vomiting scale
Postoperative nausea and vomiting scores (assessed using a 0-2 categorical scale; no nausea/nausea/vomiting)
Measured: 2, 12,24,36,48,72 hour after surgery
Occurrence of prolonged post-operative ileus
Occurrence of prolonged post-operative ileus (assessed using a 0-1 categorical scale; no ileus/ ileus)
Measured: 8 weeks after surgery
Time to first oral fluid intake
Time to first oral fluid intake after surgery
Measured: 8 weeks after surgery
Time to first oral soft diet
Time to first oral soft diet after surgery
Measured: 8 weeks after surgery
Length of hospital stay
Length of hospital stay after admission
Measured: 8 weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Apr 202031 Dec 2024

First posted25 Jan 2018
Study start8 Apr 2020
Primary completion31 Dec 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Loop IleostomyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03411096
Sponsor's protocol ID: KNUHC02
Status last verified: Mar 2025
First submitted: 19 Jan 2018
Last updated: 6 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Phasix Mesh Underlay During Loop Ileostomy Closure
Incisional Hernia of Anterior Abdominal Wall
RecruitingPhase 2/3
Prevention of Hernia After Loop Ileostomy Reversal
Loop Ileostomy
RecruitingObservational study
Implementation of an Efferent Loop Stimulation Protocol Prior to Ileostomy Closure at La Paz University Hospital
Postoperative Ileus, Colorectal Cancer Control and Prevention
Recruiting
Enteral Feeding of Fibre to Improve Microbiota
Bowel Dysfunction, Colon Disease
Active, not recruiting
PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure
Rectum Cancer

All Loop Ileostomy trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03411096
Acronym / sponsor ID: KNUHC02
Conditions: Loop Ileostomy, Colorectal Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Kyungpook National University HospitalUniversity, hospital or other
Study start: 8 Apr 2020 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 25 Jan 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Quadratus lumborum block	Experimental	Procedure: Quadratus lumborum block using ropivacaineQuadratus lumborum block with 0.75% ropivacaine
Placebo	Placebo comparator	Procedure: Quadratus lumborum block with normal salineQuadratus lumborum block with normal saline

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Quadratus lumborum block using ropivacaineAlso: Quadratus lumborum blockAfter general anesthesia, an anesthesiologist will perform an quadratus lumborum block with 0.75% ropivacaine (20cc) under ultrasound guidance.	Procedure or surgery	Quadratus lumborum block
Quadratus lumborum block with normal salineAfter general anesthesia, an anesthesiologist will perform an quadratus lumborum block with normal saline (20cc) under ultrasound guidance.	Procedure or surgery	Placebo

Primary outcome

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"

7 secondary outcomes

Pain NRS
Time frame: 2, 12,24,36,48,72 hour after surgery
Rescue opioid analgesic requirement
Time frame: postoperative day 0,1,2,3
Postoperative nausea and vomiting scale
Time frame: 2, 12,24,36,48,72 hour after surgery
Occurrence of prolonged post-operative ileus
Time frame: 8 weeks after surgery
Time to first oral fluid intake
Time frame: 8 weeks after surgery
Time to first oral soft diet
Time frame: 8 weeks after surgery
Length of hospital stay
Time frame: 8 weeks after surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.

Related trials for Loop Ileostomy

Not yet recruiting
Phasix Mesh Underlay During Loop Ileostomy Closure
Incisional Hernia of Anterior Abdominal Wall
RecruitingPhase 2/3
Prevention of Hernia After Loop Ileostomy Reversal
Loop Ileostomy
RecruitingObservational study
Implementation of an Efferent Loop Stimulation Protocol Prior to Ileostomy Closure at La Paz University Hospital
Postoperative Ileus, Colorectal Cancer Control and Prevention
Recruiting
Enteral Feeding of Fibre to Improve Microbiota
Bowel Dysfunction, Colon Disease
Active, not recruiting
PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure
Rectum Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jin Seok Yeo, MD study director

Kyungpook National University Chilgok Hospital

In Teak Woo, MD study chair

Kyungpook National University Chilgok Hospital

Soo Yeun Park, MD principal investigator

Kyungpook National University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain numerical rating scale (NRS) (time frame: 6 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03411096.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.