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

Seoul National University Hospital96 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Postoperative Pain

Interventions

acetaminophen/ibuprofen fixed-dose combinationDRUG

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

SalineDRUG

100 ml of normal saline

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Total fentanyl consumption during 24 hours

postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

Time frame: postoperative 24 hours

Secondary Outcomes

Total fentanyl consumption

postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

Time frame: postoperative 6, 48 hours

Postoperative pain score

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

Time frame: postoperative 6, 24, 48 hours

Postoperative nausea and vomiting

Incidence of postoperative nausea and vomiting (%)

Time frame: postoperative 24, 48 hours

Quality of recovery-15

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

Time frame: postoperative 24, 48 hours

Data from ClinicalTrials.gov

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