Postoperative Analgesic Effect of Subcostal TAPB for Laparoscopic Gastrectomy

Seoul National University Hospital112 enrolled

Overview

This prospective, randomized, single blinded study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided subcostal transversus abdominis plane block in gastric cancer patients undergoing laparoscopic gastrectomy. We hypothesize that US guided subcostal TAP block with ropivacaine can significantly reduce postoperative opioid comparison in patients with laparoscopic gastrectomy.

Adult patients undergoing elective laparoscopic gastrectomy are randomly allocated to receive subcostal TAP block (n=56) or not (n=56), in addition to a standard postoperative analgesic regimen comprising of IV fentanyl-based patient-controlled analgesia (PCA) and NSAIDs as required. At the end of surgery, the TAP group patients will receive bilateral subcostal TAP block under ultrasound guidance with 15ml of 0.375% ropivacaine bilaterally. Each patient was assessed by a blinded investigator at 6, 12, 24, and 48 h postoperatively. The primary outcome is total fentanyl consumption at 24 h after surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

112

Conditions

Postoperative Pain

Interventions

Ultrasound guided subcostal transversus abdominis plane block (TAPB)PROCEDURE

At the end of surgery, an anesthesiologist will perform bilateral subcostal TAP block with 0.375% ropivacaine 15ml at each site under ultrasound guidance.

Ropivacaine 0.75% Injectable SolutionDRUG

0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)

21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)DEVICE

0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients scheduled to undergo elective laparoscopic gastrectomy under general anesthesia * American Society of Anesthesiologists (ASA) physical classification I-III * Consent to IV-patient controlled analgesia use * Willingness and ability to sign an informed consent document Exclusion Criteria: * Do not understand our study * Allergies to anesthetic or analgesic medications * Wound infiltration analgesia for postoperative pain control * Infection or anatomic abnormality at the needle insertion site * Pregnancy/Breast feeder * Medical or psychological disease that can affect the treatment response

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Total fentanyl consumption during 24 hours

postoperative cumulative fentanyl consumption (mcg)

Time frame: postoperative 24 hours

Secondary Outcomes

Total fentanyl consumption

postoperative cumulative fentanyl consumption (mcg)

Time frame: postoperative 6, 12, 48 hours

Postoperative pain score

11-pointed NRS pain score at resting/coughing NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"

Time frame: postoperative 6, 12, 24, 48 hours

occurrence of opioid-related side effects

Incidence of postoperative nausea and vomiting, dizziness, sedation, respiratory depression (%)

Time frame: postoperative 6, 12, 24, 48 hours

Rescue nonopioid(ketorolac, nefopam) analgesic requirement

Overall postoperative rescue of nonopoioid(ketorolac, nefopam) analgesic requirement

Time frame: postoperative 6, 12, 24, 48 hours

Data from ClinicalTrials.gov

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