A Prospective Study on the Comparison of Postoperative Pain According to the Use of Cocktail Therapy in Laminoplasty
Study Details
Study Description
Brief Summary
This study is the first prospective randomized controlled trial to analyze the effects and safety of multimodal cocktail injections after cervical laminoplasty
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Group 1 The group that received normal saline 40ml injection into the deep fascia and muscular layer during wound closure. |
|
| Experimental: Group 2 The group that received cocktail therapy injection into the deep fascia and muscular layer during wound closure. |
Drug: Cocktail 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
Other Names:
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Outcome Measures
Primary Outcome Measures
- Change from Baseline in Pain (VAS/Visual Analog Score) [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 [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 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosed with cervical myelopathy or radiculopathy and scheduled to undergo laminoplasty
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Recorded preoperative upper limb pain (Visual Analog Scale [- VAS] ), neck pain (VAS), Japanese Orthopaedic Association (JOA) scores, and Neck Disability Index (NDI) scores.
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Adults aged 20 years and above, but below 80 years capable of articulating their own pain or functional abnormalities
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Cognitive function at a level that enables them to comprehend and adhere to study procedures
Exclusion Criteria:
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Previous surgical treatment of the cervical spine.
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Adolescents aged 20 years or below, pregnant individuals, or those with the potential for pregnancy.
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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).
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Patients who lack the capacity for medical consent or are unable to communicate effectively in a medical context.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Kyunghee University Medical Center
Investigators
- Study Chair: Kyung-Chung Kang, Associate Professor, Kyunghee University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- futurespine