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Completed

NCT Number: NCT03376048

Local Wound Infiltration Plus TAP Block Versus Local Wound Infiltration Only

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Verona Hospital Trust and Colorectal Cancer Center, Verona, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wound infiltration plus TAP

Procedure
  • 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

Wound Infiltration

Procedure

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

Other names: ropivacaine

Primary outcomes

  1. Pain numerical rating scale (NRS)

    Time frame: within the first 6 hours after surgery

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

Secondary outcomes

  1. Pain NRS

    Time frame: 12, 24, 36, 48, 72 hour after surgery

    • Pain NRS during rest and cough
    • NRS scale 0-10: 0, "no pain"; 10, "worst pain imaginable"
  2. Rescue opioid analgesic requirement

    Time frame: postoperative day 0, 1, 2, 3

    Overall postoperative rescue of opioid analgesic requirement described by using the Defined Daily Dose

  3. Postoperative nausea and vomiting scale

    Time frame: 12, 24, 36, 48, 72 hour after surgery

    PONV scores (assessed using a 0 - 2 categorical scale; no nausea/ nausea/ vomiting)

  4. Occurrence of prolonged post-operative ileus

    Time frame: 8 weeks after surgery

    Occurrence of prolonged post-operative ileus (assessed using a 0 - 1 categorical scale; no ileus/ileus)

  5. Time to first oral fluid intake

    Time frame: 8 weeks after surgery

    Time to first oral fluid intake after surgery

  6. Time to first oral soft diet

    Time frame: 8 weeks after surgery

    Time to first oral soft diet after surgery

  7. Length of hospital stay

    Time frame: 8 weeks after surgery

    Length of hospital stay after admission

Sponsors and collaborators

Lead sponsor

Kyungpook National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 18, 2017
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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