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Local Wound Infiltration Plus TAP Block Versus Local Wound Infiltration Only

K

Kyungpook National University

Status

Completed

Conditions

Colorectal Disorders

Treatments

Procedure: Wound infiltration
Procedure: Wound infiltration plus TAP

Study type

Interventional

Funder types

Other

Identifiers

NCT03376048
KNUHC01

Details and patient eligibility

About

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.

Full 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.

Enrollment

108 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

108 participants in 2 patient groups

Wound infiltration plus TAP
Experimental group
Description:
Wound infiltration placed by surgeon + TAP-LAP placed laparoscopically guided by surgeon
Treatment:
Procedure: Wound infiltration plus TAP
Wound infiltration
Active Comparator group
Description:
Wound infiltration placed by surgeon
Treatment:
Procedure: Wound infiltration

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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