Perioperative Polmacoxib Reduce Opioid Consumption for Post Operative Pain After Rotator Cuff Tear.

NCT06590714 | Recruiting

• 1 other identifier: UEMC 2024-06-015
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.\*\*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.)
2. 2.\*\*Two hours before surgery:\*\* Administration of medication begins.
3. 3.\*\*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.
4. 4.\*\*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.
5. 5.\*\*Six weeks after surgery:\*\* Collect pain scores and the cumulative number of NSAIDs-excluded non-opioid or opioid analgesic doses.
6. 6.\*\*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.

Conditions

Rotator Cuff Tear

Keywords

rotator cuff tear; reduction of Opioids; Effects of Polmacoxib Administration

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure-Cumulative administration frequency of narcotic analgesics (e.g., Fentanyl injection), excluding NSAIDs

  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.

  At postoperative day 3

Secondary Outcomes (6)

• 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

Study Arms (2)

Experimental(Acelex cap 2mg)

EXPERIMENTAL

Experimental Arm (Polmacoxib (Acelex cap 2mg) + Non-NSAID Non-Opioid or Opioid Analgesics(ULTRACET ER SEMI TAB)) 1\. Polmacoxib (preventive Acelex cap 2mg) administration, Method: One tablet orally once daily, regardless of meals.

Drug: Experimental(Acelex cap m2mg)

Active Comparator(NSAIDs-excluded non-opioid or opioid analgesics)

ACTIVE COMPARATOR

Control Group (Administration of Non-NSAID Non-Opioid or Opioid Analgesics(ULTRACET ER SEMI TAB)) 1\. Non-NSAID Non-Opioid or Opioid Analgesics(ULTRACET ER SEMI TAB), Administration Method: PRN

Drug: Active Comparator(NSAIDs-excluded non-opioid or opioid analgesics)

Interventions

Experimental(Acelex cap m2mg) DRUG

Experimental Arm (Polmacoxib (Acelex cap 2mg + NSAIDs-excluded non-opioid or opioid analgesics)) Polmacoxib (preventive Acelex cap 2mg) administered, dosage: 1 tablet orally once daily, regardless of meals. NSAIDs-excluded non-opioid or opioid analgesics, dosage: as needed (PRN).

Experimental(Acelex cap 2mg)

Active Comparator(NSAIDs-excluded non-opioid or opioid analgesics) DRUG

NSAIDs-excluded non-opioid or opioid analgesics, dosage: as needed (PRN).

Active Comparator(NSAIDs-excluded non-opioid or opioid analgesics)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eulji University Hospital: lead
• Dong-A ST Co., Ltd.: collaborator
• Seoul National University Hospital: collaborator

Study Sites (1)

Uijeongbu Eulji Medical Center, Eulji University

Uijeongbu-si, Gyeonggi-do, 11759, South Korea

RECRUITING

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Analgesics, Opioid

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Central Study Contacts

JAEMAN KWAK

CONTACT

+82 10-2300-6237; jman.kwak@gmail.com

SUIN JEONG

CONTACT

+82 10-7121-9335; jeongsuin0622@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopedics

Model Details: Rotator cuff tear patients

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: August 23, 2024
• Primary Completion: August 22, 2025
• Study Completion: August 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

KR (1)