Local Wound Infiltration Plus TAP Block Versus Local Wound Infiltration Only

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Disorders
• Intervention / Treatment: Procedure: Wound infiltration plus TAP; Procedure: Wound infiltration

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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy, 37134
    • University of Verona Hospital Trust and Colorectal Cancer Center
• Korea, Republic of
  • Daegu, Korea, Republic of, 41404
    • Kyungpook National University Chilgok Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Kyungpook National University Hospital
• Investigators: Principal Investigator: Soo Yeun Park, MD, Kyungpook National University Chilgok Hospital; Principal Investigator: Corrado Pedrazzani, MD, University of Verona Hospital Trust and Colorectal Cancer Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2017
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: KNUHC01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No