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Local Wound Infiltration Plus TAP Block Versus Local Wound Infiltration Only

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ClinicalTrials.gov Identifier: NCT03376048
Recruitment Status : Completed
First Posted : December 18, 2017
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Soo Yeun Park, Kyungpook National University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Colorectal Disorders Procedure: Wound infiltration plus TAP Procedure: Wound infiltration Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : December 20, 2017
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
  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.
Other Name: 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 Name: ropivacaine


Outcome Measures
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Primary Outcome Measures :
  1. Pain numerical rating scale (NRS) [ Time Frame: within the first 6 hours after surgery ]
    1. Pain NRS during rest and cough
    2. NRS scale 0-10: 0, "no pain"; 10, "worst pain imaginable"


Secondary Outcome Measures :
  1. Pain NRS [ Time Frame: 12, 24, 36, 48, 72 hour after surgery ]
    1. Pain NRS during rest and cough
    2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376048


Locations
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Italy
University of Verona Hospital Trust and Colorectal Cancer Center
Verona, Italy, 37134
Korea, Republic of
Kyungpook National University Chilgok Hospital
Daegu, Korea, Republic of, 41404
Sponsors and Collaborators
Kyungpook National University Hospital
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Soo Yeun Park, Colorectal Cancer Center, Kyungpook National University Chilgok Hospital, Kyungpook National University Hospital
ClinicalTrials.gov Identifier: NCT03376048    
Other Study ID Numbers: KNUHC01
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents