A Study of Cebranopadol for the Treatment of Acute Pain After Bunionectomy

Launched by TRIS PHARMA, INC. · May 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Cebranopadol to see how well it works and how safe it is for treating pain after bunion surgery, which is a procedure to correct a bunion on the foot. The trial is currently looking for participants aged 18 to 75 who are scheduled for a specific type of bunion surgery. To join the study, participants need to be able to follow the visit schedule and complete questionnaires about their pain.

If you decide to participate, you will be monitored closely to ensure your safety and to assess how well the medication is managing your pain after surgery. It's important to note that individuals with certain medical conditions, other painful issues not related to the bunion, or allergies to pain medications might not be eligible for this study. This research aims to find better ways to help manage acute pain after bunionectomy, which could lead to improved care for patients in the future.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria Before Surgery:
• • Scheduled to undergo primary unilateral bunionectomy with first metatarsal osteotomy and internal fixation with no collateral procedures, using anesthesiologic and surgical procedures planned.
• • Must be able to adhere to the visit schedule, complete all study assessments and protocol requirements, including self-reported questionnaires.
• Key Exclusion Criteria Before Surgery:
• • Any clinically significant disease, medical condition, or laboratory finding that in the investigator's opinion may interfere with the study procedures or data integrity, or compromise the safety of the subject.
• • Secondary (i.e., unrelated to bunion) current painful condition that could confound the interpretation of efficacy, safety, or tolerability data in the study, in the opinion of the investigator.
• • Subjects who require any analgesic for secondary (i.e., unrelated to bunion) painful condition that might impact the subject's ability to properly assess their postoperative pain, or that may require treatment during the Treatment Phase.
• • History of allergy or hypersensitivity to any opioid analgesics, anesthetics, ibuprofen, or other NSAIDs.
• Immediate Postoperative Exclusion Criteria:
• • Surgical, postsurgical, or anesthetic complication that could confound the interpretation of efficacy, safety, or tolerability data in the study.
• • Deviation from the surgical, postsurgical, or anesthetic protocol that could confound the interpretation of efficacy, safety, or tolerability data in the study.
• • Evidence of hemodynamic instability or respiratory insufficiency.

Trial Officials