Local Wound Infiltration Plus TAP Block Versus Local Wound Infiltration Only

Sponsor

Kyungpook National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03376048

Collaborator

(none)

108

Enrollment

Locations

Arms

24.3

Actual Duration (Months)

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

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 :

Dec 20, 2017

Actual Primary Completion Date :

Apr 30, 2019

Actual Study Completion Date :

Dec 30, 2019

Arms and Interventions

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 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
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 Names: ropivacaine

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

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

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 Names:

ropivacaine

Outcome Measures

Primary Outcome Measures

Pain numerical rating scale (NRS) [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 Outcome Measures

Pain NRS [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"
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)
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 fluid intake [8 weeks after surgery]
Time to first oral fluid intake after surgery
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Verona Hospital Trust and Colorectal Cancer Center	Verona		Italy	37134
2	Kyungpook National University Chilgok Hospital	Daegu		Korea, Republic of	41404

Sponsors and Collaborators

Kyungpook National University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Dec 18, 2017

Last Update Posted:

Feb 5, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ropivacaine

Study Results

No Results Posted as of Feb 5, 2020