Local Wound Infiltration Plus TAP Block Versus Local Wound Infiltration Only

Not Applicable

Completed

• Conditions: Colorectal Disorders
• Interventions: Procedure: Wound infiltration; Procedure: Wound infiltration plus TAP

• Registration Number: NCT03376048
• Lead Sponsor: Kyungpook National University Hospital

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.

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 Timeline

• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-15
• Study First Posted: 2017-12-18
• Study Start: 2017-12-20
• Primary Completion: 2019-04-30
• Study Completion: 2019-12-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wound infiltration	Wound infiltration	Wound infiltration placed by surgeon
Wound infiltration plus TAP	Wound infiltration plus TAP	Wound infiltration placed by surgeon + TAP-LAP placed laparoscopically guided by surgeon

Primary Outcome Measures

Name	Time	Method
Pain numerical rating scale (NRS)	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

Name	Time	Method
Pain NRS	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"
Rescue opioid analgesic requirement	postoperative day 0, 1, 2, 3	Overall postoperative rescue of opioid analgesic requirement described by using the Defined Daily Dose
Postoperative nausea and vomiting scale	12, 24, 36, 48, 72 hour after surgery	PONV scores (assessed using a 0 - 2 categorical scale; no nausea/ nausea/ vomiting)
Time to first oral fluid intake	8 weeks after surgery	Time to first oral fluid intake after surgery
Occurrence of prolonged post-operative ileus	8 weeks after surgery	Occurrence of prolonged post-operative ileus (assessed using a 0 - 1 categorical scale; no ileus/ileus)
Time to first oral soft diet	8 weeks after surgery	Time to first oral soft diet after surgery
Length of hospital stay	8 weeks after surgery	Length of hospital stay after admission

Trial Locations

Locations (2)

Kyungpook National University Chilgok Hospital; 🇰🇷 Daegu, Korea, Republic of

University of Verona Hospital Trust and Colorectal Cancer Center; 🇮🇹 Verona, Italy