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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Total fentanyl consumption during 24 hours
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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.
Eligibility Criteria
- Ages
- 19 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: acetaminophen/ibuprofen fixed-dose combination (Drug)
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.
Intervention: Saline (Drug)
Outcomes
Primary Outcomes
Total fentanyl consumption during 24 hours
Time Frame: postoperative 24 hours
postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
Secondary Outcomes
- Total fentanyl consumption(postoperative 6, 48 hours)
- Postoperative nausea and vomiting(postoperative 24, 48 hours)
- Postoperative pain score(postoperative 6, 24, 48 hours)
- Quality of recovery-15(postoperative 24, 48 hours)
Investigators
Hojin Lee, MD
Professor
Seoul National University Hospital