Colorectal Disorders
Conditions
Brief summary
The TAP block is typically performed either with ultrasound guidance (TAP-US) or laparoscopic visualization (TAP-LAP): comparison between these two technics showed no differences in pain control and use of opioid analgesics. The investigators hypothesize that WI is non-inferior to WI + TAP-block with respect to postoperative pain.
Detailed description
In colorectal surgery, laparoscopy and enhanced recovery after surgery (ERAS) programs have significantly improved the short-term outcomes (1). Although the laparoscopic approach reduces pain and recovery time, post-operative pain, nausea and vomiting still represent an issue. In order to reduce opioid related side effects, such as postoperative nausea and vomiting (PONV), constipation and prolonged post-operative ileus, non-opioid based multimodal analgesia have been recently introduced. Although epidural analgesia has gained good success, it does not seem to offer any additional clinical benefits to patients undergoing laparoscopic colorectal surgery compared to alternative analgesic technique within an ERAS program. Both local wound infiltration (WI) and TAP block are common techniques in multimodal postoperative pain treatment, and their association allows to achieve pain control despite a reduced use of opioid analgesics. Furthermore, in a recent single-blind prospective study TAP block resulted superior to wound infiltration alone. The TAP block is typically performed either with ultrasound guidance (TAP-US) or laparoscopic visualization (TAP-LAP): comparison between these two technics showed no differences in pain control and use of opioid analgesics. The aim of this study is to compare WI + TAP-LAP versus WI alone. The investigators hypothesize that WI is non-inferior to WI + TAP-block with respect to postoperative pain.
Interventions
PROCEDUREWound infiltration plus TAP
1. TAP block: At the beginning of the main surgical procedure the surgeon will perform a TAP with ropivacaine infiltration, bilaterally in the anterior axillary line, between the costal margin and iliac crest in the intermuscular plane between the internal oblique and transversus abdominis muscles, the anesthesiologist under ultrasound guidance, the surgeon under laparoscopic guidance (two pops technique). 2. Wound infiltration : Wound infiltration of ropivacaine will be performed by the surgeon before skin incision.
PROCEDUREWound infiltration
Wound infiltration of ropivacaine will be performed by the surgeon before skin incision.
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
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-80 years, either sex * Patients scheduled to undergo elective laparoscopic colorectal surgery under general anesthesia * 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 35 kg/m2 * American Society of Anesthesiologists (ASA) physical status above 3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain numerical rating scale (NRS) | within the first 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 | 12, 24, 36, 48, 72 hour after surgery | PONV 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 | 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
Italy, South Korea
Outcome results
None listed