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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Continuous Infusion of Intravenous Nefopam on Postoperative Pain and Opioid Consumption After Video Assisted Thoracic Surgery: A Double Blind Randomized Controlled Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Nefopam 80mg/day
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective randomized double-blinded study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nefopam group<br>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. | Drug: Nefopam 80mg/day<br>* continuous nefopam infusion<br>|
| Placebo Comparator: Control group<br>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 at the end of surgery. | Drug: Normal saline<br>* continuous normal saline infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total fentanyl consumption during 24 hours | postoperative fentanyl consumption (mcg) via IV patient controlled analgesia | postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total fentanyl consumption | postoperative fentanyl consumption (mcg) via IV patient controlled analgesia | 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 | postoperative 24, 48 hours | 
| Postoperative nausea and vomiting | Incidence of postoperative nausea and vomiting (%) | postoperative 24, 48 hours | 
| chronic postsurgical pain | Incidence of chronic postsurgical pain (NRS ≥ 3) (%) | 3-months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Pain