Local Wound Infiltration Plus TAP Block Versus Local Wound Infiltration Only

NCT ID: NCT03376048

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-20
• Study Completion Date: 2019-12-30

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.

Conditions

Colorectal Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Wound infiltration plus TAP

Wound infiltration placed by surgeon + TAP-LAP placed laparoscopically guided by surgeon

Group Type: EXPERIMENTAL

Wound infiltration plus TAP

Intervention Type: PROCEDURE

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.

Wound infiltration

Wound infiltration placed by surgeon

Group Type: ACTIVE_COMPARATOR

Wound infiltration

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Wound infiltration

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

Intervention Type: PROCEDURE

Other Intervention Names

ropivacaine; ropivacaine

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyungpook National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Soo Yeun Park

Colorectal Cancer Center, Kyungpook National University Chilgok Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Soo Yeun Park, MD

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Chilgok Hospital

Corrado Pedrazzani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Verona Hospital Trust and Colorectal Cancer Center

Locations

University of Verona Hospital Trust and Colorectal Cancer Center

Verona, , Italy

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Countries

Italy; South Korea

References

Pedrazzani C, Park SY, Conti C, Turri G, Park JS, Kim HJ, Polati E, Guglielmi A, Choi GS. Analgesic efficacy of pre-emptive local wound infiltration plus laparoscopic-assisted transversus abdominis plane block versus wound infiltration in patients undergoing laparoscopic colorectal resection: results from a randomized, multicenter, single-blind, non-inferiority trial. Surg Endosc. 2021 Jul;35(7):3329-3338. doi: 10.1007/s00464-020-07771-6. Epub 2020 Jul 6.

Reference Type: DERIVED

PMID: 32632489 (View on PubMed)

Pedrazzani C, Park SY, Scotton G, Park JS, Kim HJ, Polati E, Guglielmi A, Choi GS. Analgesic efficacy of preemptive local wound infiltration plus laparoscopic-assisted transversus abdominis plane block versus wound infiltration in patients undergoing laparoscopic colorectal resection: study protocol for a randomized, multicenter, single-blind, noninferiority trial. Trials. 2019 Jul 2;20(1):391. doi: 10.1186/s13063-019-3509-y.

Reference Type: DERIVED

PMID: 31266529 (View on PubMed)

Other Identifiers

KNUHC01

Identifier Type: -

Identifier Source: org_study_id