Seoul National University Hospital
Hojin Lee, MD
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.
Postoperative Pain
acetaminophen/ibuprofen fixed-dose combination
Saline
Not Applicable
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.}}
| Study Type : | Interventional |
| Estimated Enrollment : | 96 participants |
| Masking : | Quadruple |
| Masking Description : | The nurse who is not involved in this study knows the allocated group and sends the bottle of the drug which looks the same in both groups, to the operation room and ward. The care provider, investigator, patients, and outcomes assessor will be not informed of the infusion of the drug by not attaching an identifiable label so that it cannot be distinguished from normal saline. |
| Primary Purpose : | Treatment |
| 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 |
| Actual Study Start Date : | October 3, 2022 |
| Estimated Primary Completion Date : | July 14, 2023 |
| Estimated Study Completion Date : | October 15, 2023 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Maxigesic group 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 |
|
Placebo Comparator: Control group 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 |
| Ages Eligible for Study: | 19 Years to 80 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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Seoul National University Hospital
Seoul, Korea, Republic of, KS013