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

NCT05366777 | Completed

• 1 other identifier: Maxigesic_Lung
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Total fentanyl consumption during 24 hours

  postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

  postoperative 24 hours

Secondary Outcomes (4)

• Total fentanyl consumption

  postoperative 6, 48 hours

• Postoperative pain score

  postoperative 6, 24, 48 hours

• Postoperative nausea and vomiting

  postoperative 24, 48 hours

• Quality of recovery-15

  postoperative 24, 48 hours

Study Arms (2)

Maxigesic group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

acetaminophen/ibuprofen fixed-dose combination DRUG

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

Also known as: Maxigesic

Maxigesic group

Saline DRUG

100 ml of normal saline

Also known as: Placebo

Control group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Kyongbo Pharmaceutical: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, KS013, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen; Ibuprofen; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Hojin Lee, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A prospective randomized double-blinded study

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 9, 2022
• Study Start: October 3, 2022
• Primary Completion: July 14, 2023
• Study Completion: October 15, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

KR (1)