Clinical trial

Nefopam as a Multimodal Analgesia for Video-assisted Thoracoscopic Surgery

Name
NEVATS2
Description
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.
Trial arms
Trial start
2021-12-08
Estimated PCD
2022-09-23
Trial end
2022-09-23
Status
Completed
Treatment
Nefopam
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.
Arms:
nefopam group
Size
46
Primary endpoint
Pain after 1 hour of surgery
1 hour after surgery.
Pain after 6 hour of surgery
6 hours hours after surgery.
Pain after 12 hour of surgery
12 hours after surgery.
Pain after 24 hour of surgery
24 hours after surgery.
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 46, 'type': 'ACTUAL'}}
Updated at
2023-02-14

1 organization

1 product

1 indication

Product
Nefopam
Indication
lung cancer