Effects of Continuous Infusion of Intravenous Nefopam on Postoperative Pain and Opioid Consumption After VATS

Seoul National University Hospital90 enrolled

Overview

This prospective, randomized, double-blinded study is designed to evaluate the postoperative analgesic effect of the continuous infusion of intravenous nefopam in patients undergoing video-assisted thoracic surgery (VATS). We hypothesize that the continuous infusion of intravenous nefopam can significantly reduce postoperative opioid consumption and pain severity in patients with VATS.

Adult patients undergoing elective unilateral VATS segmentectomy or lobectomy are randomly allocated to receive continuous nefopam infusion (n=45) or not (n=45), in addition to a standard postoperative analgesic regimen comprising of IV fentanyl-based patient-controlled analgesia (PCA). At the end of induction, the nefopam group will receive intravenous nefopam 20mg mixed with 50ml of normal saline, and at the end of surgery this group will receive intravenous nefopam 60mg mixed with 50ml of normal saline at a rate of 2ml/hr. The control group will receive intravenous normal saline 50ml at the end of induction and receive intravenous normal saline 50ml at a rate of 2ml/hr.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Postoperative Pain

Interventions

Nefopam 80mg/dayDRUG

continuous nefopam infusion

Normal salineDRUG

continuous normal saline infusion

Eligibility

Sex: ALLMin age: 19 YearsMax age: 70 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/Breast feeder * Medical or psychological disease that can affect the treatment 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 48 hours

Postoperative pain score

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

Time frame: postoperative 24, 48 hours

Postoperative nausea and vomiting

Incidence of postoperative nausea and vomiting (%)

Time frame: postoperative 24, 48 hours

chronic postsurgical pain

Incidence of chronic postsurgical pain (NRS ≥ 3) (%)

Time frame: 3-months after surgery

Data from ClinicalTrials.gov

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