Perioperative Polmacoxib Reduce Opioid Consumption for Post Operative Pain After Rotator Cuff Tear.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Primary Outcome Measure-Cumulative administration frequency of narcotic analgesics (e.g., Fentanyl injection), excluding NSAIDs
研究概览
简要总结
- **One day (±1 day) before surgery:** The investigator or designated study staff will thoroughly explain the clinical trial process to the participant and their guardian (representative) based on the informed consent form and provide the form so that all participants and their guardians have sufficient time to read, discuss, and decide. Participants who agree to participate in the clinical trial will voluntarily sign the written consent form and receive a copy of the signed consent form before any study-related procedures are conducted. The clinical trial site will assign a screening number to patients who voluntarily provide consent and undergo screening. The screening number can be assigned in the order in which the participants sign the consent within the study site. After confirming eligibility based on inclusion/exclusion criteria, randomization will be performed to assign participants to either the treatment group or the control group (with a 1:1 ratio). If assigned to the treatment group, participants will receive 'Polacoxib (preventive Acelex cap 2mg) once daily, NSAIDs-excluded non-opioid/opioid analgesics - PRN use.' If assigned to the control group, participants will receive NSAIDs-excluded non-opioid or opioid analgesics. Data will be collected by comparing the two groups in a double-arm setup. Pain scores, UCLA/ASES scores, and joint range of motion will be collected, and this data will be valid up to 3 months before the surgery. (For patients taking NSAIDs or Ultracet, the dose will be maintained until v5.)
- **Two hours before surgery:** Administration of medication begins.
- **Three days after surgery:** Collect pain scores and the cumulative number of NSAIDs-excluded non-opioid or opioid analgesic doses (post-surgery). Non-opioid or opioid analgesics (e.g., Fentanyl injection or Ultracet) will be used to manage post-surgical pain, and the number of doses will be collected to assess the participant's pain.
- **Two weeks after surgery:** An outpatient visit will be conducted one week after discharge. Collect pain scores and the cumulative number of NSAIDs-excluded non-opioid or opioid analgesic doses at the two-week mark.
- **Six weeks after surgery:** Collect pain scores and the cumulative number of NSAIDs-excluded non-opioid or opioid analgesic doses.
- **Three months after surgery:** MRI will be performed to check for re-tears (optional for participants). This visit will be the study's completion visit, during which pain scores, UCLA/ASES scores, joint range of motion, and cumulative doses of NSAIDs-excluded non-opioid or opioid analgesics will be collected. If adverse events occurring during the treatment period have resolved before this completion visit, no additional safety follow-up will be performed, and this visit will be considered the end of the clinical trial. If adverse events have not resolved by the completion visit, follow-up will continue until the adverse events have either returned to pre-study or baseline levels, or the principal investigator or designee determines that the adverse events have stabilized, or no further follow-up is deemed necessary. This follow-up will mark the completion of the clinical trial.
详细描述
**⑧-1. Visit 0: Pre-surgery Admission, Orthopedic Ward (Consent Acquisition and Screening)** According to the investigator's judgment, patients who are considered potential candidates will be encouraged to participate in the clinical trial. One day (±1 day) before surgery, the investigator or designated study staff will thoroughly explain the clinical trial process to the participant and their guardian (representative) based on the informed consent form and provide the form so that all participants and their guardians have sufficient time to read, discuss, and decide. Participants who agree to participate in the clinical trial will voluntarily sign the written consent form and receive a copy of the signed consent form before any study-related procedures are conducted. The clinical trial site will assign a screening number to patients who voluntarily provide consent and undergo screening. The screening number can be assigned in the order in which the participants sign the consent within the study site. After confirming eligibility based on inclusion/exclusion criteria, randomization will be performed to assign participants to either the treatment group or the control group (with a 1:1 ratio). If assigned to the treatment group, participants will receive 'Polmacoxib (preventive Acelex cap 2mg) once daily,' and NSAIDs-excluded non-opioid/opioid analgesics - PRN. If assigned to the control group, participants will receive NSAIDs-excluded non-opioid or opioid analgesics. Data will be collected by comparing the two groups in a double-arm setup. Pain scores, UCLA/ASES scores, and joint range of motion will be collected, and this data will be valid up to 3 months before the surgery.
**Visit 0 Investigations and Examinations:**
- Obtain written consent
- Assign screening number
- Verify inclusion/exclusion criteria
- Collect baseline information of the participant
- Collect baseline disease information
- Physical examination
- Imaging data (MRI, X-ray, etc.)
- UCLA/ASES scores (including pain scores)
- Joint range of motion
- Randomization
-
- Visit 1: Two Hours Before Surgery, Orthopedic Ward (Medication Administration)** Medication administration begins two hours before surgery.
**Visit 1 Investigations and Examinations:**
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients over 18 years of age
- •Patients who need rotator cuff rupture or rotator cuff surgery with MRI identified osteoarthritis (especially small and medium SST dominant rupture)
- •NSAIDs unadministered patients for more than 1 month
- •Ultracet unadministered patients for more than 1 month
排除标准
- •primary fiftieth shoulder
- •including short-lived frozen shoulders
- •infectious arthritis
- •previous corticosteroid injections/surgery
- •moderate-severe arthroplasty
- •a traumatized patient
- •a central or peripheral nervous system disease
- •a mental illness that may not conform to medical or physical therapy
- •a woman of childbearing age
- •Pregnancy
- •a severe gastrointestinal ulcer
研究组 & 干预措施
Experimental(Acelex cap 2mg)
Experimental Arm (Polmacoxib (Acelex cap 2mg) + Non-NSAID Non-Opioid or Opioid Analgesics(ULTRACET ER SEMI TAB))
- Polmacoxib (preventive Acelex cap 2mg) administration, Method: One tablet orally once daily, regardless of meals.
干预措施: Experimental(Acelex cap m2mg) (Drug)
Active Comparator(NSAIDs-excluded non-opioid or opioid analgesics)
Control Group (Administration of Non-NSAID Non-Opioid or Opioid Analgesics(ULTRACET ER SEMI TAB))
- Non-NSAID Non-Opioid or Opioid Analgesics(ULTRACET ER SEMI TAB), Administration Method: PRN
干预措施: Active Comparator(NSAIDs-excluded non-opioid or opioid analgesics) (Drug)
结局指标
主要结局
Primary Outcome Measure-Cumulative administration frequency of narcotic analgesics (e.g., Fentanyl injection), excluding NSAIDs
时间窗: At postoperative day 3
Postoperative pain in subjects is managed during the hospital stay by administering non-narcotic or narcotic analgesics, excluding NSAIDs (e.g., Fentanyl injection). Pain levels are assessed by collecting data on the frequency of administration.
次要结局
- Secondary Outcome Measure-Cumulative number of doses of non-opioid analgesics excluding NSAIDs(- 3 days post-surgery - 2 weeks post-surgery - 6 weeks post-surgery - 12 weeks post-surgery)
- Secondary Outcome Measure-Range of Motion (ROM)(1 day before surgery, 12 weeks post-surgery)
- Secondary Outcome Measure-Rotator cuff re-tear status(12 weeks post-surgery)
- Secondary Outcome Measure(- 1 day before surgery - 2 weeks post-surgery - 6 weeks post-surgery - 12 weeks post-surgery)
- Primary Outcome Measure-ASES score(1 day before surgery, 12 weeks post-surgery)
- Secondary Outcome Measure-UCLA score(1 day before surgery, 12 weeks post-surgery)
研究者
Jae-Man Kwak
Assistant Professor of Orthopedics
Eulji University Hospital