Status Approved
First Submitted Date
2021/03/23
Registered Date
2021/04/07
Last Updated Date
2023/12/01
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0006067 |
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Unique Protocol ID | 2019AS0165 |
Public/Brief Title | The effect of nefopam on postoperative pain and satisfaction in patients undergoing spinal stenosis surgery |
Scientific Title | The effect of nefopam on postoperative pain and satisfaction in patients undergoing spinal stenosis surgery: double blind, randomization study |
Acronym | nefopam spine |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | 2019AS0165 |
Approval Date | 2020-07-07 |
Institutional Review Board Name | Institutional Review Board on human research of Korea University Ansan Hospital |
Institutional Review Board Address | 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do |
Institutional Review Board Telephone | 031-412-6514 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Eunsu Choi |
Title | M.D.,Ph.D |
Telephone | +82-31-412-5294 |
Affiliation | Korea University Ansan Hospital |
Address | 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Korea |
Contact Person for Public Queries | |
Name | Eunsu Choi |
Title | M.D.,Ph.D |
Telephone | +82-31-412-5294 |
Affiliation | Korea University Ansan Hospital |
Address | 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Korea |
Contact Person for Updating Information | |
Name | Eunsu Choi |
Title | M.D.,Ph.D |
Telephone | +82-31-412-5294 |
Affiliation | Korea University Ansan Hospital |
Address | 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2020-07-07 Actual | |
Target Number of Participant | 76 | |
Primary Completion Date | 2022-12-13 , Actual | |
Study Completion Date | 2022-12-30 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Korea University Ansan Hospital | |
Recruitment Status | Completed | |
Date of First Enrollment | 2020-07-07 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Pharmbio Korea |
Organization Type | Pharmaceutical Company |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Korea University Ansan Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | The most representative symptoms of lumbar spinal stenosis (LSS) are paresthesia and pain in the legs along with back pain. It is reported that 30% of patients undergoing surgery have residual symptoms after surgery. In particular, abnormal sensations of the feet or legs remain after surgery, which lowers the patient's satisfaction. Unlike back pain, the sensations of the legs do not respond significantly to the administration of narcotic analgesics, and tend to improve 2 weeks after surgery. The degree of improvement is small, and it is reported in studies. Nefopam (the drug name is acupan) is a kind of non-narcotic analgesic that acts on the central nervous system and acts on the NMDA receptors. This formulation has been shown to be effective in neuropathic pain and in reducing dysesthesia during endoscopic lumbar discectomy. Therefore,we expects that when using Nefopam before the end of anesthesia control postoperative pain , as well as the pain in the lower back, and the degree of paresthesia and pain in the legs, we would like to compare its effects with the group not receiving Nefopam. . |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Prevention |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Double |
Blinded Subject | Subject, Investigator |
Allocation | RCT |
Intervention Type | Drug |
Intervention Description | At one hour before the end of the surgery , Nefopam group receives nefopam 20 mg diluted in 20 ml normal saline and The control group receives 20 ml of normal saline for 20 minutes. |
Number of Arms | 2 |
Arm 1 |
Arm Label Nefopam group |
Target Number of Participant 38 |
|
Arm Type Active comparator |
|
Arm Description At one hour before the end of the surgery , Nefopam group receives nefopam 20 mg diluted in 20 ml normal saline |
|
Arm 2 |
Arm Label The control group |
Target Number of Participant 38 |
|
Arm Type Placebo comparator |
|
Arm Description At one hour before the end of the surgery , The control group receives 20 ml of normal saline for 20 minutes. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M48.06)Spinal stenosis, lumbar region patients diagnosed with spinal stenosis and undergoing spinal surgery. |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 20Year~75Year |
|
Description 1) Patients diagnosed with spinal stenosis due to radicular or enurogenic claudication and scheduled to undergo spinal surgery (decompressionsurgery with or without fusion) 2) Adult patients aged 20-75 3) American Society of Anesthesiology Physical Classification 1,2 patients 4) Patients with informed consent |
|
Exclusion Criteria |
) Patient with lumbar disc herniation or other spinal disorders 2)Patient with polyneuropathy, or arteriosclerosis obliterans 3)Patient with severe pain or disability in other joints 4)Patient with a psychiatric illness 5) Patient with peripheral vascular disease 6) Patient with a serious disease that may affect systemic condition, including cancer or cardiopulmonary disease 7) Patients sensitive to study drug 8) Patients with epilepsy or convulsions. 9) Patients taking irreversible monoamine oxidase inhibitors 8) Patients with a history of myocardial infarction 9) Patients with angle-closure glaucoma 10) Patients with urinary retention or urethral and prostate disorders |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | severity of paresthesia or abnormal sensation (Visual Analogue Scale) |
|
Timepoint | every 6 hours, 12 hours, 24 hours, 36 hours after the end of anesthesia |
|
Secondary Outcome(s) 1 | ||
Outcome | severity of back pain (Visual Analogue Scale) |
|
Timepoint | every 6 hours, 12 hours, 24 hours, 36 hours after the end of anesthesia |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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