Clinical trial NCT06590714: Perioperative Polmacoxib Reduce Opioid Consumption for Post Operative Pain After Rotator Cuff Tear.
Official title: Perioperative Polmacoxib Reduce Opioid Consumption for Post Operative Pain After Rotator Cuff Tear.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Tear
Keywords: rotator cuff tear
reduction of Opioids
Effects of Polmacoxib Administration
Lead sponsor: Eulji University Hospital
Sponsor class: OTHER
Collaborators: name: Dong-A ST Co., Ltd.
name: Seoul National University Hospital
First posted: 2024-09-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Rotator cuff tear patients
Primary purpose: TREATMENT

Brief summary: 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 \&#39;Polacoxib (preventive Acelex cap 2mg) once daily, NSAIDs-excluded non-opioid/opioid analgesics - PRN use.\&#39; 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.

Detailed description: \*\*⑧-1. Visit 0: Pre-surgery Admission, Orthopedic Ward (Consent Acquisition and Screening)\*\* According to the investigator\&#39;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:\*\*

1. Obtain written consent
2. Assign screening number
3. Verify inclusion/exclusion criteria
4. Collect baseline information of the participant
5. Collect baseline disease information
6. Physical examination
7. Imaging data (MRI, X-ray, etc.)
8. UCLA/ASES scores (including pain scores)
9. Joint range of motion
10. Randomization

    * 2. Visit 1: Two Hours Before Surgery, Orthopedic Ward (Medication Administration)\*\* Medication administration begins two hours before surgery.

\*\*Visit 1 Investigations and Examinations:\*\*

1. Medication administration

   * 3. Visit 2: Post-surgery Admission, Orthopedic Ward (Three Days After Surgery)\*\* Collect pain scores and the cumulative number of NSAIDs-excluded non-opioid or opioid analgesic doses (post-surgery) three days after 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.

\*\*Visit 2 Investigations and Examinations:\*\*

1. Pain scores
2. Physical examination
3. Check for adverse events
4. Cumulative number of NSAIDs-excluded non-opioid or opioid analgesic doses (post-surgery)

   * 4. Visit 3: Two Weeks After Surgery (±3 Days), Orthopedic Outpatient Clinic\*\* 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.

\*\*Visit 3 Investigations and Examinations:\*\*

1. Pain scores
2. Physical examination
3. Check for adverse events
4. Cumulative number of NSAIDs-excluded non-opioid or opioid analgesic doses (cumulative since surgery)

   * 5. Visit 4: Six Weeks After Surgery (±3 Days)\*\* Collect pain scores and the cumulative number of NSAIDs-excluded non-opioid or opioid analgesic doses at the six-week mark.

\*\*Visit 4 Investigations and Examinations:\*\*

1. Pain scores
2. Cumulative number of NSAIDs-excluded non-opioid or opioid analgesic doses (cumulative since surgery)
3. Physical examination
4. Check for adverse events

   * 6. Visit 5: Twelve Weeks After Surgery (±3 Days), Orthopedic Outpatient Clinic\*\* An 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: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Primary Outcome Measure-Cumulative administration frequency of narcotic analgesics (e.g., Fentanyl injection), excluding NSAIDs
timeFrame: At postoperative day 3
Secondary outcomes:
measure: Secondary Outcome Measure-Cumulative number of doses of non-opioid analgesics excluding NSAIDs
timeFrame: - 3 days post-surgery - 2 weeks post-surgery - 6 weeks post-surgery - 12 weeks post-surgery
measure: Secondary Outcome Measure-Range of Motion (ROM)
timeFrame: 1 day before surgery, 12 weeks post-surgery
measure: Secondary Outcome Measure-Rotator cuff re-tear status
timeFrame: 12 weeks post-surgery
measure: Secondary Outcome Measure
timeFrame: - 1 day before surgery - 2 weeks post-surgery - 6 weeks post-surgery - 12 weeks post-surgery
measure: Primary Outcome Measure-ASES score
timeFrame: 1 day before surgery, 12 weeks post-surgery
measure: Secondary Outcome Measure-UCLA score
timeFrame: 1 day before surgery, 12 weeks post-surgery
Other outcomes:
Locations:
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu Eulji Medical Center, Eulji University
state: Gyeonggi-do
Study officials:
References: