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Recruiting NCT07706348

Intraperitoneal Irrigation of Ondansteron in Combination With Lidocaine in Acute Postoperative Pain

Phase I / Phase II Interventional Acue Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ondansteron.
Who it may be relevant to
Registry conditions: Acue Postoperative Pain. Basic parameters: 20 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impact of Intraperitoneal Irrigation of Ondansteron in Combination With Lidocaine in Acute Postoperative Pain in Lower Abdominal Cancer Surgery: a Randomized Clinical Trial

Overview

This study, therefore, aimed to investigate the effect of intraperitoneal administration of ondansetron in combination to lidocaine for postoperative pain management in patients undergoing lower abdominal cancer surgery.

Detailed description

Postoperative pain relief is very important issue in any surgery. The common postoperative pain management is traditionally based on opioids (1,2). Considering opioids' adverse effects such as nausea, vomiting, sedation, drowsiness, and urinary retention, recently there is a lot of interest for f inding a safe and effective pain treatment after operation. Local anesthetics intraperitoneal instillation is recognized as a useful technique for postoperative pain management. They can reduce inflammatory response after surgery and produce analgesia by blocking neural transmission at the site of tissue injury (5). 5-HT3-antagonists, including ondansetron, are commonly used as anti-emetics to prevent and treat chemotherapy-induced vomiting and nausea \[7\]. Several studies have shown that 5-HT3-antagonists pose anti-inflammatory and analgesic properties, suggesting a potential clinical role in pain management.

Interventions

  • Drug ondansteron
    intraperitonel irrigation

Primary outcome measures

  • total morphine consumption [Time frame: in the first 24 hours postoperative]
Secondary outcome measures (1)
  • time of the first request of analgesia [Time frame: first 24 hours postoperative]

Eligibility criteria

Inclusion criteria

  • ASA I-II patients
  • scheduled for major lower abdominal cancer surgeries.

Exclusion criteria

  • patients with known allergy to the study drugs,
  • significant cardiac, respiratory, renal or hepatic disease,
  • body mass index (BMI) ≥30 kg/m2;
  • allergy to study drugs
  • history of opioid use for pain management the time of enrolment or drug addiction,
  • who had used benzodiazepine chronically,
  • stroke or psychiatric disease that could affect the perception of pain.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Assiut University - South Egypt Cancer Instiute — Asyut

Identifiers

NCT: NCT07706348 · 823

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗