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A prospective, randomized, controlled trial for the effects of parecoxib sodium on chronic post-surgical pain after surgery for digestive system tumors in elderly patients

A prospective, randomized, controlled trial for the effects of parecoxib sodium on chronic post-surgical pain after surgery for digestive system tumors in elderly patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035198
Enrollment
Unknown
Registered
2020-08-03
Start date
2018-11-06
Completion date
Unknown
Last updated
2020-08-10

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

Conditions

chronic post-surgical pain

Interventions

Parecoxib sodium +PCEA:Intravenous injection of Parecoxib sodium 40mg (diluted with normal saline to 4mL) started immediately before surgery and continued for 3 days after surgery
The placebo + PCEA:Intravenous injection of placebo (normal saline of 4mL) started immediately before surgery and continued for 3 days after surgery

Sponsors

Zhongshan Hospital affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing laparotomy for digestive system tumor surgery under general anesthesia combined with epidural block; 2. Aged 65 to 80 years old; 3. ASA I~II grade; 4. The study was examined by the ethics committee and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. There are contraindications to epidural anesthesia 2. History of chronic pain 3. History of mental illness 4. Definite diagnosis of heart or vascular disease, renal insufficiency, liver insufficiency (alanine aminotransferase or alanine aminotransferase >40U/L); 5. With pregnancy; 6. Inability to communicate; 7. Participated in other clinical studies within three months.

Design outcomes

Primary

MeasureTime frame
The incidence of chronic pain 3 months after surgery;Pain score of patients with chronic pain 3 months after surgery;

Secondary

MeasureTime frame
Visual analogue scale (VAS) score of pain at rest and cough within 72h after operation;PCA compression times and dosage within 72 hours after operation;Postoperative nausea and vomiting (PONV) degree;perioperative inflammation index changes including leukocyte count, neutrophil count, lymphocyte count, prothrombin time, activated clotting time live enzymes, high sensitive c-reactive protein and tumor necrosis factor and interleukin 1 beta, interleukin 2 receptor, interleukin 6 and interleukin 8, interleukin 10;

Countries

China

Contacts

Public ContactGe Shengjin

Zhongshan Hospital affiliated to Fudan University

ge.shengjin@fudan.edu.cn+86 13601926171

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 22, 2026