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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Pain numerical rating scale (NRS)
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Quadratus lumborum block
Quadratus lumborum block with 0.75% ropivacaine
Intervention: Quadratus lumborum block using ropivacaine (Procedure)
Placebo
Quadratus lumborum block with normal saline
Intervention: Quadratus lumborum block with normal saline (Procedure)
Outcomes
Primary Outcomes
Pain numerical rating scale (NRS)
Time Frame: 6 hours after surgery
1. Pain NRS during rest and cough 2. NRS scale 0-10:0, "no pain"; 10, "worst pain imaginable"
Secondary Outcomes
- Pain NRS(2, 12,24,36,48,72 hour after surgery)
- Rescue opioid analgesic requirement(postoperative day 0,1,2,3)
- Postoperative nausea and vomiting scale(2, 12,24,36,48,72 hour after surgery)
- Occurrence of prolonged post-operative ileus(8 weeks after surgery)
- Time to first oral fluid intake(8 weeks after surgery)
- Length of hospital stay(8 weeks after surgery)
- Time to first oral soft diet(8 weeks after surgery)
Investigators
Soo Yeun Park
Principal Investigator
Kyungpook National University Hospital