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Completed

NCT Number: NCT03411096

Quadratus Lumborum Block : Local Anesthesia Versus Placebo

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.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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.

Primary outcomes

  1. Pain numerical rating scale (NRS)

    Time frame: 6 hours after surgery

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

Secondary outcomes

  1. Pain NRS

    Time frame: 2, 12,24,36,48,72 hour after surgery

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

  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)

  4. 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)

  5. Time to first oral fluid intake

    Time frame: 8 weeks after surgery

    Time to first oral fluid intake after surgery

  6. Time to first oral soft diet

    Time frame: 8 weeks after surgery

    Time to first oral soft diet after surgery

  7. Length of hospital stay

    Time frame: 8 weeks after surgery

    Length of hospital stay after admission

Sponsors and collaborators

Lead sponsor

Kyungpook National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 25, 2018
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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