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Clinical trial

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

ID
Name
futurespine
Description
This study is the first prospective randomized controlled trial to analyze the effects and safety of multimodal cocktail injections after cervical laminoplasty
Trial arms
Trial start
2023-11-25
Estimated PCD
2024-10-24
Trial end
2025-09-30
Status
Not yet recruiting
Phase
Early phase I
Treatment
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
Arms:
Group 2
Other names:
Normal saline injection
Size
60
Primary endpoint
Change from Baseline in Pain (VAS/Visual Analog Score)
Baseline and Post operation 7 days
Change from Baseline in function (JOA/Japanese Orthopaedic Association Score) score
Baseline and Post operation 7 days
Change from Baseline in function (NDI/Neck Disability Index score) score
Baseline and Post operation 7 days
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-11-14

1 organization

1 product

3 indications

Organization
Kyunghee University Medical Center
Product
Cocktail
Indication
Analgesic
Indication
Antipyretic and Anti-Inflammatory Drug
Indication
Unspecified