Adverse Effects in the Therapeutic Use of Analgesic, Antipyretic and Anti-Inflammatory Drug, UnspecifiedPhase 4NCT06113497
A Prospective Study on the Comparison of Postoperative Pain According to the Use of Cocktail Therapy in Laminoplasty
A Phase 4 study testing Cocktail injection in people with Adverse Effects in the Therapeutic Use of Analgesic, Antipyretic and Anti-Inflammatory Drug, Unspecified, run by Kyunghee University Medical Center.
Trial summary
This study is the first prospective randomized controlled trial to analyze the effects and safety of multimodal cocktail injections after cervical laminoplasty Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Effects in the Therapeutic Use of Analgesic, Antipyretic and Anti-Inflammatory Drug, Unspecified
- What is being tested?
- Cocktail injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2023to 30 Sep 2025
- Phase
- Phase 4
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with cervical myelopathy or radiculopathy and scheduled to undergo laminoplasty
- Recorded preoperative upper limb pain (Visual Analog Scale [- VAS] ), neck pain (VAS), Japanese Orthopaedic Association (JOA) scores, and Neck Disability Index (NDI) scores.
- Adults aged 20 years and above, but below 80 years capable of articulating their own pain or functional abnormalities
- Cognitive function at a level that enables them to comprehend and adhere to study procedures
Who cannot join
- Previous surgical treatment of the cervical spine.
- Adolescents aged 20 years or below, pregnant individuals, or those with the potential for pregnancy.
- Hypersensitivity reactions to mixed medications used in Cocktail therapy. (morphine 5 mg, ropiva 150 mg, tamceton 40 mg, epinephrine 1 mg, ketocin 60 mg, jetiam 1 g).
- Patients who lack the capacity for medical consent or are unable to communicate effectively in a medical context.
Trial locations and contacts
No sites are listed yet.
Won-Young Lee, Fellow contact
About this study
This study is the first prospective randomized controlled trial to analyze the effects and safety of multimodal cocktail injections after cervical laminoplasty
Read the detailed description
This study is the first prospective randomized controlled trial to analyze the effects and safety of multimodal cocktail injections after cervical laminoplasty. Through this study, we anticipate that the potential usefulness of multimodal cocktail analgesic injections in various aspects of spinal surgery will be demonstrated, offering valuable insights and possibilities.
- Being tested
- Cocktail injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocktail injectionDrug
Also called Normal saline injection
Morphine 5 mg, ropivacaine 150 mg, tramadol 40 mg, epinephrine 1 mg, ketorolac 60 mg, and ketamine 1 g will be mixed with normal saline to prepare a total volume of 60 ml
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | The group that received normal saline 40ml injection into the deep fascia and muscular layer during wound closure. |
| Group 2 | Experimental | The group that received cocktail therapy injection into the deep fascia and muscular layer during wound closure. Receives: Drug: Cocktail injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Pain (VAS/Visual Analog Score)
A VAS score, also known as a Visual Analog Scale score, is a common method used in healthcare and research to measure subjective or self-reported sensations or experiences, such as pain, anxiety, mood, or other subjective states. It typically consists of a horizontal or vertical line, usually 10 centimeters in length, with anchor points at either end. One end is labeled with the most negative or extreme aspect of the sensation or experience being measured, and the other end is labeled with the most positive or least extreme aspect.
Measured: Baseline and Post operation 7 days
Change from Baseline in function (JOA/Japanese Orthopaedic Association Score) score
The JOA score is often calculated based on a specific set of criteria and is used to help guide treatment decisions and monitor a patient's progress. It provides a standardized way to assess and communicate the clinical status of individuals with cervical myelopathy. The score may range from 0 (severe impairment) to 17 (normal function), with lower scores indicating greater disability.
Measured: Baseline and Post operation 7 days
Change from Baseline in function (NDI/Neck Disability Index score) score
The NDI questionnaire typically consists of ten questions or items, and individuals are asked to rate their level of disability or limitation in various aspects of daily life due to neck pain. The questions cover a range of activities, including personal care, work, sleep, and recreational activities. Each question is scored on a scale from 0 to 5, with 0 indicating no disability and 5 indicating severe disability. The individual's responses to these questions are then totaled to calculate the NDI score, usually expressed as a percentage.
Measured: Baseline and Post operation 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start25 Nov 2023 (estimated)
- Primary completion24 Oct 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
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 Adverse Effects in the Therapeutic Use of Analgesic, Antipyretic and Anti-Inflammatory Drug, UnspecifiedStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyung-Chung Kang, Kyunghee University Medical Center
- Investigators
- Kyung-Chung Kang, Associate Professor, Study chair, Kyunghee University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113497
- Sponsor's protocol ID
- futurespine
- Status last verified
- Nov 2023
- First submitted
- 23 Oct 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Soh J, Park HS, Lee WY, Park SH, Kang KC. The effects of multimodal cocktail analgesic local injection in postoperative pain control after laminoplasty: A study protocol of a prospective randomized controlled trial. PLoS One. 2025 Jun 13;20(6):e0324791. doi: 10.1371/journal.pone.0324791. eCollection 2025.
PubMed 40512737
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Comparison of Postoperative Pain According to the Use of Cocktail Therapy in Laminoplasty
- ClinicalTrials.gov ID
- NCT06113497
- Acronym / sponsor ID
- futurespine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Study start
- 25 Nov 2023 (estimated)
- Primary completion
- 24 Oct 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 2 Nov 2023 (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.
This study is the first prospective randomized controlled trial to analyze the effects and safety of multimodal cocktail injections after cervical laminoplasty
Detailed description
This study is the first prospective randomized controlled trial to analyze the effects and safety of multimodal cocktail injections after cervical laminoplasty. Through this study, we anticipate that the potential usefulness of multimodal cocktail analgesic injections in various aspects of spinal surgery will be demonstrated, offering valuable insights and possibilities.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –The group that received normal saline 40ml injection into the deep fascia and muscular layer during wound closure. |
| Group 2 | Experimental | Drug: Cocktail injectionThe group that received cocktail therapy injection into the deep fascia and muscular layer during wound closure. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with cervical myelopathy or radiculopathy and scheduled to undergo laminoplasty
- Recorded preoperative upper limb pain (Visual Analog Scale [- VAS] ), neck pain (VAS), Japanese Orthopaedic Association (JOA) scores, and Neck Disability Index (NDI) scores.
- Adults aged 20 years and above, but below 80 years capable of articulating their own pain or functional abnormalities
- Cognitive function at a level that enables them to comprehend and adhere to study procedures
Key exclusion criteria (4 listed)
- Previous surgical treatment of the cervical spine.
- Adolescents aged 20 years or below, pregnant individuals, or those with the potential for pregnancy.
- Hypersensitivity reactions to mixed medications used in Cocktail therapy. (morphine 5 mg, ropiva 150 mg, tamceton 40 mg, epinephrine 1 mg, ketocin 60 mg, jetiam 1 g).
- Patients who lack the capacity for medical consent or are unable to communicate effectively in a medical context.
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 |
|---|---|---|
| Cocktail injectionAlso: Normal saline injectionMorphine 5 mg, ropivacaine 150 mg, tramadol 40 mg, epinephrine 1 mg, ketorolac 60 mg, and ketamine 1 g will be mixed with normal saline to prepare a total volume of 60 ml | Drug | Group 2 |
Primary outcome
Change from Baseline in Pain (VAS/Visual Analog Score)
Time frame: Baseline and Post operation 7 days
A VAS score, also known as a Visual Analog Scale score, is a common method used in healthcare and research to measure subjective or self-reported sensations or experiences, such as pain, anxiety, mood, or other subjective states. It typically consists of a horizontal or vertical line, usually 10 centimeters in length, with anchor points at either end. One end is labeled with the most negative or extreme aspect of the sensation or experience being measured, and the other end is labeled with the most positive or least extreme aspect.
Change from Baseline in function (JOA/Japanese Orthopaedic Association Score) score
Time frame: Baseline and Post operation 7 days
The JOA score is often calculated based on a specific set of criteria and is used to help guide treatment decisions and monitor a patient's progress. It provides a standardized way to assess and communicate the clinical status of individuals with cervical myelopathy. The score may range from 0 (severe impairment) to 17 (normal function), with lower scores indicating greater disability.
Change from Baseline in function (NDI/Neck Disability Index score) score
Time frame: Baseline and Post operation 7 days
The NDI questionnaire typically consists of ten questions or items, and individuals are asked to rate their level of disability or limitation in various aspects of daily life due to neck pain. The questions cover a range of activities, including personal care, work, sleep, and recreational activities. Each question is scored on a scale from 0 to 5, with 0 indicating no disability and 5 indicating severe disability. The individual's responses to these questions are then totaled to calculate the NDI score, usually expressed as a percentage.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Derived from this study: PubMed 40512737Soh J, Park HS, Lee WY, Park SH, Kang KC. The effects of multimodal cocktail analgesic local injection in postoperative pain control after laminoplasty: A study protocol of a prospective randomized controlled trial. PLoS One. 2025 Jun 13;20(6):e0324791. doi: 10.1371/journal.pone.0324791. eCollection 2025.
- Individual participant dataSharing planned: No
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.
Won-Young Lee, Fellow contact
Kyung-Chung Kang, Associate Professor study chair
Kyunghee University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cocktail injection in people with Adverse Effects in the Therapeutic Use of Analgesic, Antipyretic and Anti-Inflammatory Drug, Unspecified, run by Kyunghee University Medical Center.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyung-Chung Kang, Associate Professor (+82)010-9933-1193, futurespine@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Pain (VAS/Visual Analog Score) (time frame: Baseline and Post operation 7 days). The study lists 3 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 NCT06113497, 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 Nov 2023.