Local Wound Infiltration Plus TAP Block Versus Local Wound Infiltration Only

NCT03376048 | Completed

• 1 other identifier: KNUHC01
• Study Type: interventional
• Target: 108
• Locations: 2 countries
• Sites: 2

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.

Conditions

Colorectal Disorders

Outcome Measures

Primary Outcomes (1)

• Pain numerical rating scale (NRS)

  1. Pain NRS during rest and cough 2. NRS scale 0-10: 0, "no pain"; 10, "worst pain imaginable"

  within the first 6 hours after surgery

Secondary Outcomes (7)

• Pain NRS

  12, 24, 36, 48, 72 hour after surgery

• Rescue opioid analgesic requirement

  postoperative day 0, 1, 2, 3

• Postoperative nausea and vomiting scale

  12, 24, 36, 48, 72 hour after surgery

• Occurrence of prolonged post-operative ileus

  8 weeks after surgery

• Time to first oral fluid intake

  8 weeks after surgery

Study Arms (2)

Wound infiltration plus TAP

EXPERIMENTAL

Wound infiltration placed by surgeon + TAP-LAP placed laparoscopically guided by surgeon

Procedure: Wound infiltration plus TAP

Wound infiltration

ACTIVE COMPARATOR

Wound infiltration placed by surgeon

Procedure: Wound infiltration

Interventions

Wound infiltration plus TAP PROCEDURE

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.

Also known as: ropivacaine

Wound infiltration plus TAP

Wound infiltration PROCEDURE

Wound infiltration of ropivacaine will be performed by the surgeon before skin incision.

Also known as: ropivacaine

Wound infiltration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyungpook National University Hospital: lead

Study Sites (2)

University of Verona Hospital Trust and Colorectal Cancer Center

Verona, 37134, Italy

Location

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

Location

Related Publications (2)

• 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.

  PMID: 32632489 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.

  PMID: 31266529 DERIVED

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Colorectal Cancer Center, Kyungpook National University Chilgok Hospital

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 18, 2017
• Study Start: December 20, 2017
• Primary Completion: April 30, 2019
• Study Completion: December 30, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1); IT (1)