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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05366777
• Other study ID #: Maxigesic_Lung
• Status: Completed
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: October 15, 2023

Study information

• Verified date: December 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: October 15, 2023
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• acetaminophen/ibuprofen fixed-dose combination
Intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) fixed-dose combination (total 100 ml)
• Saline
100 ml of normal saline

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Kyongbo Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total fentanyl consumption during 24 hours	postoperative fentanyl consumption (mcg) via IV patient controlled analgesia	postoperative 24 hours
Secondary	Total fentanyl consumption	postoperative fentanyl consumption (mcg) via IV patient controlled analgesia	postoperative 6, 48 hours
Secondary	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
Secondary	Postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting (%)	postoperative 24, 48 hours
Secondary	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