Quadratus Lumborum Block : Local Anesthesia Versus Placebo

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: Recruiting
• Conditions: Colorectal Disorders; Loop Ileostomy
• Intervention / Treatment: Procedure: Quadratus lumborum block using ropivacaine; Procedure: Quadratus lumborum block with normal saline

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: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Soo Yeun Park, MD; Phone Number: +82-10-8575-9619; Email: psy-flower@daum.net

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 41404
    • Recruiting
    • Kyungpook National University Chilgok Hospital
    • Contact: Soo Yeun Park, MD; Phone Number: +82-10-8575-9619; Email: psy-flower@daum.net

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Pain numerical rating scale (NRS)	Pain NRS during rest and cough; NRS scale 0-10:0, "no pain"; 10, "worst pain imaginable"	6 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain NRS	Pain NRS during rest and cough; NRS scale 0-10:0, "no pain"; 10, "worst pain imaginable"	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	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)	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)	8 weeks after surgery
Time to first oral fluid intake	Time to first oral fluid intake after surgery	8 weeks after surgery
Time to first oral soft diet	Time to first oral soft diet after surgery	8 weeks after surgery
Length of hospital stay	Length of hospital stay after admission	8 weeks after surgery

Collaborators and Investigators

• Sponsor: Kyungpook National University Hospital
• Investigators: 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

Study Major Dates

• Study Start (Actual): April 8, 2020
• Primary Completion (Estimated): March 28, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: January 19, 2018
• First Posted (Actual): January 25, 2018

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 7, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID 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