Quadratus Lumborum Block : Local Anesthesia Versus Placebo

NCT03411096 | Completed

• 1 other identifier: KNUHC02
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Loop Ileostomy; Colorectal Disorders

Outcome Measures

Primary Outcomes (1)

• Pain numerical rating scale (NRS)

  1. Pain NRS during rest and cough 2. NRS scale 0-10:0, "no pain"; 10, "worst pain imaginable"

  6 hours after surgery

Secondary Outcomes (7)

• Pain NRS

  2, 12,24,36,48,72 hour after surgery

• Rescue opioid analgesic requirement

  postoperative day 0,1,2,3

• Postoperative nausea and vomiting scale

  2, 12,24,36,48,72 hour after surgery

• Occurrence of prolonged post-operative ileus

  8 weeks after surgery

• Time to first oral fluid intake

  8 weeks after surgery

Study Arms (2)

Quadratus lumborum block

EXPERIMENTAL

Quadratus lumborum block with 0.75% ropivacaine

Procedure: Quadratus lumborum block using ropivacaine

Placebo

PLACEBO COMPARATOR

Quadratus lumborum block with normal saline

Procedure: Quadratus lumborum block with normal saline

Interventions

Quadratus lumborum block using ropivacaine PROCEDURE

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

Also known as: Quadratus lumborum block

Quadratus lumborum block

Quadratus lumborum block with normal saline PROCEDURE

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

Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyungpook National University Hospital: lead

Study Sites (1)

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jin Seok Yeo, MD

  Kyungpook National University Chilgok Hospital

  STUDY DIRECTOR

• In Teak Woo, MD

  Kyungpook National University Chilgok Hospital

  STUDY CHAIR

• Soo Yeun Park, MD

  Kyungpook National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: January 25, 2018
• Study Start: April 8, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

KR (1)