Nefopam as a Multimodal Analgesia for Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
Acute postoperative pain after video-assisted thoracoscopic surgery is very severe. Because pain after thoracic surgery prevents early recovery, and increases postoperative complications, its is important to prevent pain after video-assisted thoracoscopic surgery. In the present study, we will evaluate whether nefopam reduces pain after video-assisted thoracoscopic surgery.

Official Title
-----------------
Nefopam as a Multimodal Analgesia for Video-assisted Thoracoscopic Surgery

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: Nefopam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient scheduled for elective video-assisted thoracoscopic surgery American Society of Anesthesiologists physical grade I, II, III patient aged from 18 years old Exclusion Criteria: history of allergy in nonsteroidal anti-inflammatory drugs, or nefopam renal insufficiency liver insufficiency myocardial infarction glaucoma pregnant and lactating women at the time of surgery patient who did not consent to the use of patient-controlled analgesia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>Nefopam will not be administered in this group. | |
| Experimental: nefopam group<br>Intravenous nefopam 20 mg will be administered twice, immediately after induction of anesthesia and at the end of surgery. | Drug: Nefopam<br>* Nefopam 20 mg is mixed to 100 mL of normal saline, and is infused intravenously over 15 minutes. 20 mg of nefopam is administered intravenously for two times, after induction and at the end of surgery.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain after 1 hour of surgery | Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever). | 1 hour after surgery. | 
| Pain after 6 hour of surgery | Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever). | 6 hours hours after surgery. | 
| Pain after 12 hour of surgery | Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever). | 12 hours after surgery. | 
| Pain after 24 hour of surgery | Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever). | 24 hours after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-controlled analgesia use | Fentanyl consumption administered thorough the patient-controlled analgesia machine. | 24 hours after surgery | 
| Rescue analgesics | Additional analgesic use during postoperative period. | 24 hours after surgery. |