Clinical trial NCT05366777: Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination on Postoperative Opioid Consumption
Official title: Effect of an Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination on Postoperative Opioid Consumption and Pain After Video-assisted Thoracic Surgery: A Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Postoperative Pain
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Kyongbo Pharmaceutical
First posted: 2022-05-09
Enrollment: 96
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective randomized double-blinded study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total fentanyl consumption during 24 hours
timeFrame: postoperative 24 hours
Secondary outcomes:
measure: Total fentanyl consumption
timeFrame: postoperative 6, 48 hours
measure: Postoperative pain score
timeFrame: postoperative 6, 24, 48 hours
measure: Postoperative nausea and vomiting
timeFrame: postoperative 24, 48 hours
measure: Quality of recovery-15
timeFrame: postoperative 24, 48 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hojin Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: