Quadratus Lumborum Block : Local Anesthesia Versus Placebo

• Sponsor: Kyungpook National University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03411096
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 33.1
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Loop Ileostomy; Colorectal Disorders	Procedure: Quadratus lumborum block using ropivacaine; Procedure: Quadratus lumborum block with normal saline	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Mar 30, 2020
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Pain numerical rating scale (NRS) [6 hours after surgery]

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

Secondary Outcome Measures

1. Pain NRS [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 [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 [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 [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 [8 weeks after surgery]

   Time to first oral fluid intake after surgery

6. Time to first oral soft diet [8 weeks after surgery]

   Time to first oral soft diet after surgery

7. Length of hospital stay [8 weeks after surgery]

   Length of hospital stay after admission

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyungpook National University Chilgok Hospital	Daegu		Korea, Republic of	41404

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Soo Yeun Park, Principal Investigator, Kyungpook National University Hospital
• ClinicalTrials.gov Identifier: NCT03411096
• Other Study ID Numbers: KNUHC02
• First Posted: Jan 25, 2018
• Last Update Posted: Feb 5, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ropivacaine

Study Results

No Results Posted as of Feb 5, 2020