Quadratus Lumborum Block : Local Anesthesia Versus Placebo

Colorectal Disorders Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03411096
• Other study ID #: KNUHC02
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Kyungpook National University Hospital
• Contact: Soo Yeun Park, MD
• Phone: +82-10-8575-9619
• Email: psy-flower[@]daum.net
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: March 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Disorders
• Loop Ileostomy

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Rescue opioid analgesic requirement	Overall postoperative rescue of opioid analgesic requirement described by using the Defined Daily Dose	postoperative day 0,1,2,3
Secondary	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
Secondary	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
Secondary	Time to first oral fluid intake	Time to first oral fluid intake after surgery	8 weeks after surgery
Secondary	Time to first oral soft diet	Time to first oral soft diet after surgery	8 weeks after surgery
Secondary	Length of hospital stay	Length of hospital stay after admission	8 weeks after surgery