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NCT Number: NCT05366777

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, KS013, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen/Ibuprofen fixed-dose combination

Drug

Intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) fixed-dose combination (total 100 ml)

Other names: Maxigesic

Saline

Drug

100 ml of normal saline

Other names: Placebo

Primary outcomes

  1. Total fentanyl consumption during 24 hours

    Time frame: postoperative 24 hours

    postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

Secondary outcomes

  1. Total fentanyl consumption

    Time frame: postoperative 6, 48 hours

    postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

  2. Postoperative pain score

    Time frame: postoperative 6, 24, 48 hours

    11-pointed NRS pain score at resting/coughing NRS (0-10): 0,"no pain"; 10, "worst pain imaginable"

  3. Postoperative nausea and vomiting

    Time frame: postoperative 24, 48 hours

    Incidence of postoperative nausea and vomiting (%)

  4. Quality of recovery-15

    Time frame: postoperative 24, 48 hours

    Korean version of Quality of recovery-15 questionnaire (0-150): 0, "very poor recovery"; 150, "excellent recovery"

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Kyongbo Pharmaceutical

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 9, 2022
Registry last updated
Dec 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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