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

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: acetaminophen/ibuprofen fixed-dose combination; Drug: Saline

• Registration Number: NCT05366777
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study First Submitted: 2022-05-04
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-09
• Study Start: 2022-10-03
• Primary Completion: 2023-07-14
• Study Completion: 2023-10-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-17
• Last Update Posted: 2023-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maxigesic group	acetaminophen/ibuprofen fixed-dose combination	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.
Control group	Saline	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.

Primary Outcome Measures

Name	Time	Method
Total fentanyl consumption during 24 hours	postoperative 24 hours	postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of