Local Wound Infiltration Plus TAP Block Versus Local Wound Infiltration Only

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Analgesic Efficacy of Local Wound Infiltration Plus Transversus Abdominis Plane Block and Local Wound Infiltration Only After Laparoscopic Colorectal Resection: a Randomized, Double-blind, Non-inferiority Trial

Conditions
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Colorectal Disorders

Intervention / Treatment
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* Procedure: Wound infiltration plus TAP
* Procedure: Wound infiltration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wound infiltration plus TAP<br>Wound infiltration placed by surgeon + TAP-LAP placed laparoscopically guided by surgeon | Procedure: Wound infiltration plus TAP<br>* 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). Wound infiltration : Wound infiltration of ropivacaine will be performed by the surgeon before skin incision.<br>* Other names: ropivacaine;|
| Active Comparator: Wound infiltration<br>Wound infiltration placed by surgeon | Procedure: Wound infiltration<br>* Wound infiltration of ropivacaine will be performed by the surgeon before skin incision.<br>* Other names: ropivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain numerical rating scale (NRS) | Pain NRS during rest and cough NRS scale 0-10: 0, no pain; 10, worst pain imaginable | within the first 6 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain NRS | Pain NRS during rest and cough NRS scale 0-10: 0, no pain; 10, worst pain imaginable | 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 | 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 |