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

Kyung Hee University

Status and phase: Not yet enrolling; Phase 4

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

Treatments: Drug: Cocktail injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06113497

futurespine

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Group 1

No Intervention group

Description:

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

Group 2

Experimental group

Description:

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

Treatment:

Drug: Cocktail injection