Quadratus Lumborum Block : Local Anesthesia Versus Placebo

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Loop Ileostomy, Colorectal Disorders

Intervention / Treatment
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* Procedure: Quadratus lumborum block using ropivacaine
* Procedure: Quadratus lumborum block with normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quadratus lumborum block<br>Quadratus lumborum block with 0.75% ropivacaine | Procedure: Quadratus lumborum block using ropivacaine<br>* After general anesthesia, an anesthesiologist will perform an quadratus lumborum block with 0.75% ropivacaine (20cc) under ultrasound guidance.<br>* Other names: Quadratus lumborum block;|
| Placebo Comparator: Placebo<br>Quadratus lumborum block with normal saline | Procedure: Quadratus lumborum block with normal saline<br>* After general anesthesia, an anesthesiologist will perform an quadratus lumborum block with normal saline (20cc) under ultrasound guidance.<br>|

What is the study measuring?
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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 |