gastric cancer
Conditions
Interventions
Control group: The patient is placed under epidural anesthesia during surgery, and epidural anesthesia is used for postoperative analgesia.
Intervention group: Wound local anesthesia is performed at
Sponsors
Gastrointestinal Cancer Conference study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven adenocarcinoma of the stomach 2) Surgically resectable tumor (cStageI-III) by laparoscopic gastrectomy 3) Age 20 > years 4) ECOG performance status 0 or 1. 5) Cases with adequately maintained organ functions and fullfilling the following conditions within 4 weeks before registration. WBC>3000 Plt>100000 AST<100 ALT<100 Total bilrbin<2.0mg/dL Serum creatinine<1.5mg/dL 6) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with synchronous or metachronous malignancies. 2) Inappropriate for epidural anesthesia 3) Patients with Hugh-Jones II or higher pulmonary disease 4) Unstable angina pectoris or history of myocardial infarction within 6 months. 5) Uncontrollable hypertension. 6) Uncontrollable diabetes mellitus 7) History of hypersensitivity of acetaminophen 8) History of hypersensitivity of ropivacaine hydrochloride hydrate or lidocaine hydrochloride 9) History of hypersensitivity of aspirin-induced asthma 10) Continuous systemic steroid therapy. 11) Women during pregnancy or breast feeding. 12) Judged inappropriate by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with a resting NRS score of 4 or higher at 24 hours after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Pain-related outcomes Area under the NRS-time curve during the first 72 hours (AUC72) Time course of NRS scores at rest and during coughing Number of rescue analgesic doses through POD3 Patient satisfaction assessed using a 7-point Likert scale (1-7) 2.Operative and anesthetic variables Operative time and anesthetic time 3.Postoperative recovery outcomes Time to first flatus and defecation Time to ambulation Time to urinary catheter removal Length of postoperative hospital stay 4.Safety outcomes Incidence and severity of analgesia-related adverse events Incidence and severity of postoperative surgical complications (Clavien-Dindo classification) Laboratory abnormalities, including hepatotoxicity, graded by CTCAE v4.0 5.Exploratory (post hoc) analyses Proportion of patients with an NRS score >=4 at rest (48 and 72 hours) and during coughing (24, 48, and 72 hours) (These exploratory analyses were added after study completion to ensure transparency and did not alter the study conduct or interpretation.) | — |
Countries
Japan
Contacts
Public ContactJun Kinoshita
Kanazawa University Gastroenterologic Surgery
Outcome results
None listed