Clinical trial NCT03411096: Quadratus Lumborum Block : Local Anesthesia Versus Placebo
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loop Ileostomy
Colorectal Disorders
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 57
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Pain numerical rating scale (NRS)
timeFrame: 6 hours after surgery
Secondary outcomes:
measure: Pain NRS
timeFrame: 2, 12,24,36,48,72 hour after surgery
measure: Rescue opioid analgesic requirement
timeFrame: postoperative day 0,1,2,3
measure: Postoperative nausea and vomiting scale
timeFrame: 2, 12,24,36,48,72 hour after surgery
measure: Occurrence of prolonged post-operative ileus
timeFrame: 8 weeks after surgery
measure: Time to first oral fluid intake
timeFrame: 8 weeks after surgery
measure: Time to first oral soft diet
timeFrame: 8 weeks after surgery
measure: Length of hospital stay
timeFrame: 8 weeks after surgery
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
Study officials:
affiliation: Kyungpook National University Chilgok Hospital
name: Jin Seok Yeo, MD
role: STUDY_DIRECTOR
affiliation: Kyungpook National University Chilgok Hospital
name: In Teak Woo, MD
role: STUDY_CHAIR
affiliation: Kyungpook National University Hospital
name: Soo Yeun Park, MD
role: PRINCIPAL_INVESTIGATOR
References: