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

• Status: Not yet recruiting
• Trial end date: 2025-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kyunghee University Medical Center

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.