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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wound infiltration plus TAP | Experimental | Wound infiltration placed by surgeon + TAP-LAP placed laparoscopically guided by surgeon |
|
| Wound infiltration | Active Comparator | Wound infiltration placed by surgeon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wound infiltration plus TAP | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain numerical rating scale (NRS) |
| within the first 6 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain NRS |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soo Yeun Park, MD | Kyungpook National University Chilgok Hospital | Principal Investigator |
| Corrado Pedrazzani, MD | University of Verona Hospital Trust and Colorectal Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Verona Hospital Trust and Colorectal Cancer Center | Verona | 37134 | Italy | |||
| Kyungpook National University Chilgok Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32632489 | Derived | Pedrazzani C, Park SY, Conti C, Turri G, Park JS, Kim HJ, Polati E, Guglielmi A, Choi GS. Analgesic efficacy of pre-emptive local wound infiltration plus laparoscopic-assisted transversus abdominis plane block versus wound infiltration in patients undergoing laparoscopic colorectal resection: results from a randomized, multicenter, single-blind, non-inferiority trial. Surg Endosc. 2021 Jul;35(7):3329-3338. doi: 10.1007/s00464-020-07771-6. Epub 2020 Jul 6. | |
| 31266529 |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
|
| Wound infiltration | Procedure | Wound infiltration of ropivacaine will be performed by the surgeon before skin incision. |
|
|
| postoperative day 0, 1, 2, 3 |
| Postoperative nausea and vomiting scale | PONV scores (assessed using a 0 - 2 categorical scale; no nausea/ nausea/ vomiting) | 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) | 8 weeks after surgery |
| Time to first oral fluid intake | Time to first oral fluid intake after surgery | 8 weeks after surgery |
| Time to first oral soft diet | Time to first oral soft diet after surgery | 8 weeks after surgery |
| Length of hospital stay | Length of hospital stay after admission | 8 weeks after surgery |
| Daegu |
| 41404 |
| South Korea |
| Derived |
| Pedrazzani C, Park SY, Scotton G, Park JS, Kim HJ, Polati E, Guglielmi A, Choi GS. Analgesic efficacy of preemptive local wound infiltration plus laparoscopic-assisted transversus abdominis plane block versus wound infiltration in patients undergoing laparoscopic colorectal resection: study protocol for a randomized, multicenter, single-blind, noninferiority trial. Trials. 2019 Jul 2;20(1):391. doi: 10.1186/s13063-019-3509-y. |
| D000588 |
| Amines |