Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590714
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Perioperative Polmacoxib Reduce Opioid Consumption for Post Operative Pain After Rotator Cuff Tear
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Perioperative Polmacoxib Reduce Opioid Consumption for Post Operative Pain After Rotator Cuff Tear
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 inclusionexclusion criteria randomization will be performed to assign participants to either the treatment group or the control group with a 11 ratio If assigned to the treatment group participants will receive 39Polacoxib preventive Acelex cap 2mg once daily NSAIDs-excluded non-opioidopioid analgesics - PRN use39 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 UCLAASES 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 eg Fentanyl injection or Ultracet will be used to manage post-surgical pain and the number of doses will be collected to assess the participants 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 studys completion visit during which pain scores UCLAASES 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
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 eg Fentanyl injection or Ultracet will be used to manage post-surgical pain and the number of doses will be collected to assess the participants 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 studys completion visit during which pain scores UCLAASES 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 investigator39s 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 inclusionexclusion criteria randomization will be performed to assign participants to either the treatment group or the control group with a 11 ratio If assigned to the treatment group participants will receive Polmacoxib preventive Acelex cap 2mg once daily and NSAIDs-excluded non-opioidopioid 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 UCLAASES 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 inclusionexclusion criteria
4 Collect baseline information of the participant
5 Collect baseline disease information
6 Physical examination
7 Imaging data MRI X-ray etc
8 UCLAASES 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 eg Fentanyl injection or Ultracet will be used to manage post-surgical pain and the number of doses will be collected to assess the participants 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 studys completion visit during which pain scores UCLAASES 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
Visit 0 Investigations and Examinations
1 Obtain written consent
2 Assign screening number
3 Verify inclusionexclusion criteria
4 Collect baseline information of the participant
5 Collect baseline disease information
6 Physical examination
7 Imaging data MRI X-ray etc
8 UCLAASES 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 eg Fentanyl injection or Ultracet will be used to manage post-surgical pain and the number of doses will be collected to assess the participants 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 studys completion visit during which pain scores UCLAASES 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None