Who is eligible for clinical trial NCT07571252?

Participants must meet the protocol's inclusion criteria for Post Operative Pain. The stated age range is 21 Years to 65 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT07571252 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-22

Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery (NCT07571252)

Impact of Preemptive Analgesia on Postoperative Pain in Patients Undergoing Orthognathic Surgery: A Randomized Controlled Trial.

🟡 Not Yet Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: University of Puerto Rico

🩺 Plain-English Summary (8th-Grade Level)

This randomized controlled clinical trial evaluates the effect of preemptive analgesia on postoperative pain outcomes in adult patients undergoing orthognathic surgery. Participants scheduled for bilateral sagittal split osteotomy and Le Fort I osteotomy under general anesthesia will be randomized to one of three groups: intravenous acetaminophen, intravenous ibuprofen, or a control group receiving standard postoperative analgesia without preoperative medication. The study aims to determine whether the administration of pre-surgical analgesics reduces postoperative pain intensity and analgesic requirements during the early postoperative period. Pain will be assessed using a standardized pain scale at multiple time points following surgery, and secondary outcomes will include postoperative analgesic consumption and patient satisfaction with pain control. This investigation seeks to contribute evidence supporting multimodal analgesic strategies and improved postoperative pain management in patients undergoing orthognathic surgery.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (9 items).

Location: Administración de Servicios Médicos (ASEM) — San Juan

Age range: 21 Years to 65 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Adults aged 21 to 65 years.
American Society of Anesthesiologists (ASA) physical status I or II.
Scheduled to undergo orthognathic surgery including bilateral sagittal split osteotomy and Le Fort I osteotomy under general anesthesia.
Ability to understand the study procedures and provide written informed consent.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Pregnancy or breastfeeding.
Known allergy or intolerance to acetaminophen, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs).
Renal dysfunction, defined as estimated glomerular filtration rate \<60 mL/min/1.73 m².
Hepatic dysfunction, defined as liver enzyme levels greater than twice the upper limit of normal.
History of bleeding disorders or coagulopathy.
Active or recent peptic ulcer disease.
Current use of recreational drugs, including cannabis, that in the judgment of the investigators could interfere with anesthesia management, postoperative pain assessment, or study outcomes.
Any medical condition that, in the judgment of the investigators, would make participation unsafe or interfere with study participation.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Administración de Servicios Médicos (ASEM) — San Juan,

📞 Contact the Study Coordinator

Phone: (787) 758-2525

Email: dennys.rivera@upr.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗