- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04450355
Effects of Continuous Infusion of Intravenous Nefopam on Postoperative Pain and Opioid Consumption After VATS
May 4, 2022 updated by: Hojin Lee, MD, Seoul National University Hospital
Effects of Continuous Infusion of Intravenous Nefopam on Postoperative Pain and Opioid Consumption After Video Assisted Thoracic Surgery: A Double Blind Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, KS013
- Seoul National University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nefopam group
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.
|
continuous nefopam infusion
|
Placebo Comparator: Control group
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.
|
continuous normal saline infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total fentanyl consumption during 24 hours
Time Frame: postoperative 24 hours
|
postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
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postoperative 24 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total fentanyl consumption
Time Frame: postoperative 48 hours
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postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
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postoperative 48 hours
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Postoperative pain score
Time Frame: postoperative 24, 48 hours
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11-pointed NRS pain score at resting/coughing/movement NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"
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postoperative 24, 48 hours
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Postoperative nausea and vomiting
Time Frame: postoperative 24, 48 hours
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Incidence of postoperative nausea and vomiting (%)
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postoperative 24, 48 hours
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chronic postsurgical pain
Time Frame: 3-months after surgery
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Incidence of chronic postsurgical pain (NRS ≥ 3) (%)
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3-months after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Du Manoir B, Aubrun F, Langlois M, Le Guern ME, Alquier C, Chauvin M, Fletcher D. Randomized prospective study of the analgesic effect of nefopam after orthopaedic surgery. Br J Anaesth. 2003 Dec;91(6):836-41. doi: 10.1093/bja/aeg264.
- Tirault M, Derrode N, Clevenot D, Rolland D, Fletcher D, Debaene B. The effect of nefopam on morphine overconsumption induced by large-dose remifentanil during propofol anesthesia for major abdominal surgery. Anesth Analg. 2006 Jan;102(1):110-7. doi: 10.1213/01.ANE.0000181103.07170.15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 30, 2020
Primary Completion (Actual)
August 9, 2021
Study Completion (Actual)
November 10, 2021
Study Registration Dates
First Submitted
June 24, 2020
First Submitted That Met QC Criteria
June 24, 2020
First Posted (Actual)
June 29, 2020
Study Record Updates
Last Update Posted (Actual)
May 6, 2022
Last Update Submitted That Met QC Criteria
May 4, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2001-036-1092
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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