Colorectal Disorders, Loop Ileostomy
Conditions
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).
Interventions
PROCEDUREQuadratus lumborum block using ropivacaine
After general anesthesia, an anesthesiologist will perform an quadratus lumborum block with 0.75% ropivacaine (20cc) under ultrasound guidance.
PROCEDUREQuadratus lumborum block with normal saline
After general anesthesia, an anesthesiologist will perform an quadratus lumborum block with normal saline (20cc) under ultrasound guidance.
Sponsors
Kyungpook National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain numerical rating scale (NRS) | 6 hours after surgery | 1. Pain NRS during rest and cough 2. NRS scale 0-10:0, no pain; 10, worst pain imaginable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rescue opioid analgesic requirement | postoperative day 0,1,2,3 | Overall postoperative rescue of opioid analgesic requirement described by using the Defined Daily Dose |
| 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) |
| 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) |
| Pain NRS | 2, 12,24,36,48,72 hour after surgery | 1. Pain NRS during rest and cough 2. NRS scale 0-10:0, no pain; 10, worst pain imaginable |
| Time to first oral soft diet | 8 weeks after surgery | Time to first oral soft diet after surgery |
| Length of hospital stay | 8 weeks after surgery | Length of hospital stay after admission |
| Time to first oral fluid intake | 8 weeks after surgery | Time to first oral fluid intake after surgery |
Countries
South Korea
Outcome results
None listed