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

NCT06113497 | Unknown Phase 4

• 1 other identifier: futurespine
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Change from Baseline in Pain (VAS/Visual Analog Score)

  A VAS score, also known as a Visual Analog Scale score, is a common method used in healthcare and research to measure subjective or self-reported sensations or experiences, such as pain, anxiety, mood, or other subjective states. It typically consists of a horizontal or vertical line, usually 10 centimeters in length, with anchor points at either end. One end is labeled with the most negative or extreme aspect of the sensation or experience being measured, and the other end is labeled with the most positive or least extreme aspect.

  Baseline and Post operation 7 days

• Change from Baseline in function (JOA/Japanese Orthopaedic Association Score) score

  The JOA score is often calculated based on a specific set of criteria and is used to help guide treatment decisions and monitor a patient's progress. It provides a standardized way to assess and communicate the clinical status of individuals with cervical myelopathy. The score may range from 0 (severe impairment) to 17 (normal function), with lower scores indicating greater disability.

  Baseline and Post operation 7 days

• Change from Baseline in function (NDI/Neck Disability Index score) score

  The NDI questionnaire typically consists of ten questions or items, and individuals are asked to rate their level of disability or limitation in various aspects of daily life due to neck pain. The questions cover a range of activities, including personal care, work, sleep, and recreational activities. Each question is scored on a scale from 0 to 5, with 0 indicating no disability and 5 indicating severe disability. The individual's responses to these questions are then totaled to calculate the NDI score, usually expressed as a percentage.

  Baseline and Post operation 7 days

Study Arms (2)

Group 1

NO INTERVENTION

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

Group 2

EXPERIMENTAL

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

Drug: Cocktail injection

Interventions

Cocktail injection 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

Also known as: Normal saline injection

Group 2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyunghee University Medical Center: lead

Related Publications (1)

• Soh J, Park HS, Lee WY, Park SH, Kang KC. The effects of multimodal cocktail analgesic local injection in postoperative pain control after laminoplasty: A study protocol of a prospective randomized controlled trial. PLoS One. 2025 Jun 13;20(6):e0324791. doi: 10.1371/journal.pone.0324791. eCollection 2025.

  PMID: 40512737 DERIVED

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Kyung-Chung Kang, Associate Professor

  Kyunghee University

  STUDY CHAIR

Central Study Contacts

Kyung-Chung Kang, Associate Professor

CONTACT

+82)010-9933-1193; futurespine@gmail.com

Won-Young Lee, Fellow

CONTACT

+82)010-3623-9038

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Spine Center, Department of Orthopaedic Surgery

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 2, 2023
• Study Start: November 25, 2023
• Primary Completion: October 24, 2024
• Study Completion: September 30, 2025
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share