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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEulji University Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

primary fiftieth shoulder

including short-lived frozen shoulders

infectious arthritis

previous corticosteroid injections/surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

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

    Drug

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

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Experimental(Acelex cap 2mg)Experimental treatment 1 intervention
Group B: Active Comparator(NSAIDs-excluded non-opioid or opioid analgesics)Active comparator 1 intervention

Trial outcomes

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.

Time frame
At postoperative day 3

Secondary outcomes

1

Secondary Outcome Measure-Cumulative number of doses of non-opioid analgesics excluding NSAIDs

\- Cumulative number of doses of non-opioid analgesics excluding NSAIDs (e.g., Ultracet)

Time frame
- 3 days post-surgery - 2 weeks post-surgery - 6 weeks post-surgery - 12 weeks post-surgery
2

Secondary Outcome Measure-Range of Motion (ROM)

Range of Motion (ROM)

Time frame
1 day before surgery, 12 weeks post-surgery
3

Secondary Outcome Measure-Rotator cuff re-tear status

Rotator cuff re-tear status

Time frame
12 weeks post-surgery
4

Secondary Outcome Measure

* VAS pain scale * The VAS pain scale can be expressed using 11 levels, represented by numbers from 0 to 10. In this case, the patient selects a number that corresponds to the intensity of the pain they are experiencing, ranging from 0 (no pain) to 10 (the worst imaginable pain). The meaning of each number is as follows: 0: No pain 1-3: Mild pain 4-6: Moderate pain 7-9: Severe pain 10: Worst possible pain

Time frame
- 1 day before surgery - 2 weeks post-surgery - 6 weeks post-surgery - 12 weeks post-surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eulji University Hospital

Lead sponsor

Dong-A ST Co., Ltd.

Collaborator

Seoul National University Hospital

Collaborator