Local Wound Infiltration Plus TAP Block Versus Local Wound Infiltration Only

Colorectal Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03376048
• Other study ID #: KNUHC01
• Status: Completed
• Phase: N/A
• Start date: December 20, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: February 2020
• Source: Kyungpook National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Disorders

Intervention

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

Locations

Country	Name	City	State
Italy	University of Verona Hospital Trust and Colorectal Cancer Center	Verona
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University Hospital

Countries where clinical trial is conducted

Italy,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain numerical rating scale (NRS)	Pain NRS during rest and cough; NRS scale 0-10: 0, "no pain"; 10, "worst pain imaginable"	within the first 6 hours after surgery
Secondary	Pain NRS	Pain NRS during rest and cough; NRS scale 0-10: 0, "no pain"; 10, "worst pain imaginable"	12, 24, 36, 48, 72 hour after surgery
Secondary	Rescue opioid analgesic requirement	Overall postoperative rescue of opioid analgesic requirement described by using the Defined Daily Dose	postoperative day 0, 1, 2, 3
Secondary	Postoperative nausea and vomiting scale	PONV scores (assessed using a 0 - 2 categorical scale; no nausea/ nausea/ vomiting)	12, 24, 36, 48, 72 hour after surgery
Secondary	Occurrence of prolonged post-operative ileus	Occurrence of prolonged post-operative ileus (assessed using a 0 - 1 categorical scale; no ileus/ileus)	8 weeks after surgery
Secondary	Time to first oral fluid intake	Time to first oral fluid intake after surgery	8 weeks after surgery
Secondary	Time to first oral soft diet	Time to first oral soft diet after surgery	8 weeks after surgery
Secondary	Length of hospital stay	Length of hospital stay after admission	8 weeks after surgery