A pilot study for calculating sample size to evaluate the effectiveness of Maxigesic® on postoperative pain control in patients undergoing laparoscopic gastrectomy

A pilot study for calculating sample size to evaluate the effectiveness of Maxigesic® on the reduction of opioid dose in intravenous patient-controlled analgesia for postoperative pain management in patients undergoing laparoscopic gastrectomy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0009934

Enrollment

Registered

2024-11-20

Start date

2024-10-28

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

None listed

Interventions

Drug : Maxigesic or placebo (normal saline) was randomly assigned as an adjuvant used for postoperative analgesia

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 20 to under 80 years 2. Patients receiving postoperative pain management through intravenous patient-controlled analgesia (IV-PCA) 3. Patients who have voluntarily provided written consent to participate in this clinical study

Exclusion criteria

Exclusion criteria: 1. Patients weighing less than 50 kg 2. Patients with a history of hypersensitivity to acetaminophen, ibuprofen, or other NSAIDs 3. Patients receiving continuous analgesic medication for chronic pain 4. Patients for whom the use of IV-PCA and pain assessment are deemed difficult due to cognitive impairment and communication limitations 5. Patients with active alcohol addiction 6. Patients with AST (aspartate transaminase) levels exceeding 80 IU/L 7. Patients with ALT (alanine transaminase) levels exceeding 80 IU/L 8. Patients with an estimated glomerular filtration rate (eGFR, calculated by CKD-EPI) less than 60 mL/min/1.73 m² 9. Patients with a history of ischemic heart disease or severe heart failure (left ventricular ejection fraction less than 40%) 10. Patients with a history of bronchial asthma 11. Patients with a history of gastrointestinal ulcers or bleeding 12. Patients taking barbiturates or tricyclic antidepressants 13. Pregnant or lactating women 14. Patients deemed unsuitable by the investigator for other reasons

Design outcomes

Primary

Measure	Time frame
Cumulative dose of oxycodone administered via IV-PCA	—

Secondary

Measure	Time frame
Cumulative dose of oxycodone administered via IV-PCA;Frequency and total dosage of rescue analgesics administered in the PACU and ward;Area under curve for pain scores assessed using the NRS;Quality of recovery assessed using the QoR-15K;Changes in body temperature;Simulated plasma concentrations of oxycodone	—

Countries

Korea, Republic of

Contacts

Public ContactKyung Mi Kim

Asan Medical Center

sumsonyo@gmail.com+82-2-3010-1704

Outcome results