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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-25

Study Completion Date

2025-09-30

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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group 1

The group that received normal saline 40ml injection into the deep fascia and muscular layer during wound closure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2

The group that received cocktail therapy injection into the deep fascia and muscular layer during wound closure.

Group Type EXPERIMENTAL

Cocktail injection

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Normal saline injection

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes