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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Adverse Effects in the Therapeutic Use of Analgesic, Antipyretic and Anti-Inflammatory Drug, Unspecified
• Intervention / Treatment: Drug: Cocktail injection

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kyung-Chung Kang, Associate Professor; Phone Number: +82)010-9933-1193; Email: futurespine@gmail.com
• Study Contact Backup: Name: Won-Young Lee, Fellow; Phone Number: +82)010-3623-9038

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group 1; The group that received normal saline 40ml injection into the deep fascia and muscular layer during wound closure.
Experimental: Group 2; The group that received cocktail therapy injection into the deep fascia and muscular layer during wound closure.	Drug: 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; Other Names: Normal saline injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kyunghee University Medical Center
• Investigators: Study Chair: Kyung-Chung Kang, Associate Professor, Kyunghee University

Study record dates

Study Major Dates

• Study Start (Estimated): November 25, 2023
• Primary Completion (Estimated): October 24, 2024
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: November 1, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 12, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: futurespine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No