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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
108
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.
Wound infiltration of ropivacaine will be performed by the surgeon before skin incision.
University of Verona Hospital Trust and Colorectal Cancer Center
Verona, Italy
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Pain numerical rating scale (NRS)
1. Pain NRS during rest and cough 2. NRS scale 0-10: 0, "no pain"; 10, "worst pain imaginable"
Time frame: within the first 6 hours after surgery
Pain NRS
1. Pain NRS during rest and cough 2. NRS scale 0-10: 0, "no pain"; 10, "worst pain imaginable"
Time frame: 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
Time frame: postoperative day 0, 1, 2, 3
Postoperative nausea and vomiting scale
PONV scores (assessed using a 0 - 2 categorical scale; no nausea/ nausea/ vomiting)
Time frame: 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)
Time frame: 8 weeks after surgery
Time to first oral fluid intake
Time to first oral fluid intake after surgery
Time frame: 8 weeks after surgery
Time to first oral soft diet
Time to first oral soft diet after surgery
Time frame: 8 weeks after surgery
Length of hospital stay
Length of hospital stay after admission
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Time frame: 8 weeks after surgery