NCT07571252 Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery
| NCT ID | NCT07571252 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Puerto Rico |
| Condition | Post Operative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2026-09 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 72 participants in total. It began in 2026-09 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07571252 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 65 Years, studying Post Operative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07571252 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07571252 currently recruiting?
Yes, NCT07571252 is actively recruiting participants. Contact the research team at dennys.rivera@upr.edu for enrollment information.
Where is the NCT07571252 trial being conducted?
This trial is being conducted at San Juan, Puerto Rico.
Who is sponsoring the NCT07571252 clinical trial?
NCT07571252 is sponsored by University of Puerto Rico. The trial plans to enroll 72 participants.