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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: acetaminophen/ibuprofen fixed-dose combination
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective randomized double-blinded study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maxigesic group<br>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. | Drug: acetaminophen/ibuprofen fixed-dose combination<br>* Intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) fixed-dose combination (total 100 ml)<br>* Other names: Maxigesic;|
| Placebo Comparator: Control group<br>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. | Drug: Saline<br>* 100 ml of normal saline<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total fentanyl consumption during 24 hours | postoperative fentanyl consumption (mcg) via IV patient controlled analgesia | postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total fentanyl consumption | postoperative fentanyl consumption (mcg) via IV patient controlled analgesia | postoperative 6, 48 hours | 
| Postoperative pain score | 11-pointed NRS pain score at resting/coughing NRS (0-10): 0,no pain; 10, worst pain imaginable | postoperative 6, 24, 48 hours | 
| Postoperative nausea and vomiting | Incidence of postoperative nausea and vomiting (%) | postoperative 24, 48 hours | 
| Quality of recovery-15 | Korean version of Quality of recovery-15 questionnaire (0-150): 0, very poor recovery; 150, excellent recovery | postoperative 24, 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Pain