Status:
UNKNOWN
A Prospective Study on the Comparison of Postoperative Pain According to the Use of Cocktail Therapy in Laminoplasty
Lead Sponsor:
Kyunghee University Medical Center
Conditions:
Adverse Effects in the Therapeutic Use of Analgesic, Antipyretic and Anti-Inflammatory Drug, Unspecified
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06113497
Start Date
November 25 2023
End Date
September 30 2025
Last Update
November 14 2023
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