A Prospective Study on the Comparison of Postoperative Pain According to the Use of Cocktail Therapy in Laminoplasty

Study Overview
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Brief Summary
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This study is the first prospective randomized controlled trial to analyze the effects and safety of multimodal cocktail injections after cervical laminoplasty

Detailed Description
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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.

Official Title
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A Prospective Study on the Comparison of Postoperative Pain According to the Use of Cocktail Therapy in Laminoplasty

Conditions
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Adverse Effects in the Therapeutic Use of Analgesic, Antipyretic and Anti-Inflammatory Drug, Unspecified

Intervention / Treatment
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* Drug: Cocktail injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 1<br>The group that received normal saline 40ml injection into the deep fascia and muscular layer during wound closure. | |
| Experimental: Group 2<br>The group that received cocktail therapy injection into the deep fascia and muscular layer during wound closure. | Drug: Cocktail injection<br>* 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<br>* Other names: Normal saline injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Baseline and Post operation 7 days |