Not Yet RecruitingPhase 4

Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery

Puerto Rico72 participantsStarted 2026-04

Plain-language 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.

Who can participate

Age range21 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Postoperative Pain Intensity

Timeframe: 1 hour, 4 hours, and 24 hours after surgery

Trial details

NCT IDNCT07571252

SponsorUniversity of Puerto Rico

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Dennys Rivera Pérez, MD

7877582525 dennys.rivera@upr.edu