Clinical trial NCT03376048: Local Wound Infiltration Plus TAP Block Versus Local Wound Infiltration Only
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Disorders
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain numerical rating scale (NRS)
timeFrame: within the first 6 hours after surgery
Secondary outcomes:
measure: Pain NRS
timeFrame: 12, 24, 36, 48, 72 hour after surgery
measure: Rescue opioid analgesic requirement
timeFrame: postoperative day 0, 1, 2, 3
measure: Postoperative nausea and vomiting scale
timeFrame: 12, 24, 36, 48, 72 hour after surgery
measure: Occurrence of prolonged post-operative ileus
timeFrame: 8 weeks after surgery
measure: Time to first oral fluid intake
timeFrame: 8 weeks after surgery
measure: Time to first oral soft diet
timeFrame: 8 weeks after surgery
measure: Length of hospital stay
timeFrame: 8 weeks after surgery
Other outcomes:
Locations:
city: Verona
country: Italy
facility: University of Verona Hospital Trust and Colorectal Cancer Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
Study officials:
affiliation: Kyungpook National University Chilgok Hospital
name: Soo Yeun Park, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Verona Hospital Trust and Colorectal Cancer Center
name: Corrado Pedrazzani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.