Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination on Postoperative Opioid Consumption

Seoul National University

Status: Completed

Conditions: Postoperative Pain

Treatments: Drug: acetaminophen/ibuprofen fixed-dose combination; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05366777

Maxigesic_Lung

Details and patient eligibility

About

This prospective, randomized, double-blinded study is designed to evaluate the postoperative analgesic effect of the intravenous acetaminophen/ibuprofen fixed-dose combination in patients undergoing video-assisted thoracic surgery (VATS). We hypothesize that the intravenous acetaminophen/ibuprofen fixed-dose combination can significantly reduce postoperative opioid consumption and pain severity in patients with VATS.

Full description

Adult patients undergoing elective unilateral VATS wedge resection, segmentectomy, or lobectomy are randomly allocated to receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) fixed-dose combination (n=48) or not (n=48). At the end of induction, the intervention group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 min, every 6 hours, a total of 4 times. The control group will receive intravenous normal saline with the same volume and same time points as the intervention group receives.

Enrollment: 96 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled to undergo elective unilateral VATS segmentectomy or lobectomy under general anesthesia
• American Society of Anesthesiologists (ASA)physical classification I-II
• Consent to IV-patient controlled analgesia use
• Willingness and ability to sign an informed consent document

Exclusion criteria

• Do not understand our study
• Allergies to anesthetic or analgesic medications
• Continuous local anesthetics infiltration for postoperative pain control
• Patients who receive mechanical ventilation more than 2 hours after surgery
• Pregnancy/Breastfeeder
• Medical or psychological disease that can affect thetreatment response

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 2 patient groups, including a placebo group

Maxigesic group

Experimental group

Description:

At the end of induction, the Maxigesic group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 min, every 6 hours, a total of 4 times.

Treatment:

Drug: acetaminophen/ibuprofen fixed-dose combination

Control group

Placebo Comparator group

Description:

At the end of induction, the control group will receive intravenous normal saline with the same volume and same time points as the intervention group receives.

Treatment:

Drug: Saline