Lung CancerNCT05173337
Nefopam as a Multimodal Analgesia for Thoracic Surgery
A study testing Nefopam in people with Lung Cancer, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Nefopam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Dec 2021to 23 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient scheduled for elective video-assisted thoracoscopic surgery
- American Society of Anesthesiologists physical grade I, II, III
- patient aged from 18 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nefopam as a Multimodal Analgesia for Video-assisted Thoracoscopic Surgery
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.
- Conditions
- Lung Cancer
- Being tested
- Nefopam
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NefopamDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Nefopam will not be administered in this group. |
| nefopam group | Experimental | Intravenous nefopam 20 mg will be administered twice, immediately after induction of anesthesia and at the end of surgery. Receives: Drug: Nefopam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 24 hours after surgery.
Secondary outcomes (2)
Patient-controlled analgesia use
Fentanyl consumption administered thorough the patient-controlled analgesia machine.
Measured: 24 hours after surgery
Rescue analgesics
Additional analgesic use during postoperative period.
Measured: 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start8 Dec 2021
- Primary completion23 Sep 2022
- Study completion23 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eunah Cho, MD, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173337
- Sponsor's protocol ID
- NEVATS2
- Status last verified
- Feb 2023
- First submitted
- 17 Aug 2021
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ki HS, Shim JG, Choi HK, Ryu KH, Kang DY, Park J, Ahn JH, Lee SH, Cho EA. Nefopam as a multimodal analgesia in thoracoscopic surgery: a randomized controlled trial. J Thorac Dis. 2024 Jun 30;16(6):3644-3654. doi: 10.21037/jtd-24-30. Epub 2024 Jun 12.
PubMed 38983158
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nefopam as a Multimodal Analgesia for Video-assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT05173337
- Acronym / sponsor ID
- NEVATS2
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Nefopam will not be administered in this group. |
| nefopam group | Experimental | Drug: NefopamIntravenous nefopam 20 mg will be administered twice, immediately after induction of anesthesia and at the end of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient scheduled for elective video-assisted thoracoscopic surgery
- American Society of Anesthesiologists physical grade I, II, III
- patient aged from 18 years old
Key exclusion criteria (7 listed)
- history of allergy in nonsteroidal anti-inflammatory drugs, or nefopam
- renal insufficiency
- liver insufficiency
- myocardial infarction
- glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NefopamNefopam 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. | Drug | nefopam group |
Primary outcome
Pain after 1 hour of surgery
Time frame: 1 hour after surgery.
Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).
Pain after 6 hour of surgery
Time frame: 6 hours hours after surgery.
Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).
Pain after 12 hour of surgery
Time frame: 12 hours after surgery.
Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).
Pain after 24 hour of surgery
Time frame: 24 hours after surgery.
Acute postoperative pain will be assessed using numerical rating scale from 0 (no pain) to 10 (worst pain ever).
2 secondary outcomes
Patient-controlled analgesia use
Time frame: 24 hours after surgery
Rescue analgesics
Time frame: 24 hours after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Derived from this study: PubMed 38983158Ki HS, Shim JG, Choi HK, Ryu KH, Kang DY, Park J, Ahn JH, Lee SH, Cho EA. Nefopam as a multimodal analgesia in thoracoscopic surgery: a randomized controlled trial. J Thorac Dis. 2024 Jun 30;16(6):3644-3654. doi: 10.21037/jtd-24-30. Epub 2024 Jun 12.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nefopam in people with Lung Cancer, run by Kangbuk Samsung Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain after 1 hour of surgery (time frame: 1 hour after surgery.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05173337, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.