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A Randomized, Multicenter, Repeat-Dose Study of Intravenous Acetaminophen With Epidural Analgesia for the Treatment of Pain After Gastrectomy

A Randomized, Multicenter, Repeat-Dose Study of Intravenous Acetaminophen With Epidural Analgesia for the Treatment of Pain After Gastrectomy - A Randomized Study of Intravenous Acetaminophen for the Pain After Gastrecotmy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000022710
Enrollment
90
Registered
2016-06-12
Start date
2016-06-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

intravenous acetaminophen(1000mg) for every 6 hours for 72 postoperative hours in conjunction with epidural analgesia after distal gastrectomy epidural analgesia as standard treatment after dista

Sponsors

Digestive Disease Support Organization (DDSO)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically proven adenocarcinoma of the stomach 2) Surgically resectable tumor (cT1-4a, N0-3b, M0) by distal gastrectomy 3) Age 20 > years 4) ECOG performance status 0 or 1. 5) No prior treatment of chemotherapy or radiation therapy against any other malignancies. 6) Cases with adequately maintained organ functions and fullfilling the following conditions within 8 weeks before registration. WBC>3000 Plt>100000 AST<100 ALT<100 Total bilrbin<2.0mg/dL Serum creatinine<1.5mg/dL 7) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ. 2) Inappropriate for epidural anesthesia 3) Infectious disease with a systemic therapy indicated. 4) Body temperature of 38C or more. 5) History of hypersensitivity of acetaminophen 6) History of hypersensitivity of aspirin-induced asthma 7) Severe mental disease. 8) Continuous systemic steroid therapy. 9) Unstable angina pectoris or history of myocardial infarction within 6 months. 10) Uncontrollable hypertension. 11) Uncontrollable diabetes mellitus 12) Severe respiratory disease requiring continuous oxygen therapy. 13) Women during pregnancy or breast feeding. 14) Judged inappropriate by the investigators

Design outcomes

Primary

MeasureTime frame
The number of requiring rescue analgesics of edidural analgesia after surgery for 48 hours

Countries

Japan

Contacts

Public ContactJun Kinoshita

Digestive Disease Support Organization (DDSO) Gastroenterologic surgery

junkino0416@gmail.com076-265-2000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026