Impact of Preemptive Analgesia on Postoperative Pain in Patients Undergoing Orthognathic Surgery: A Randomized Controlled Trial.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 65
Healthy Volunteers: f
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• 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.
Locations
Other Locations
Puerto Rico
Administración de Servicios Médicos (ASEM)
RECRUITING
San Juan
Contact Information
Primary
Dennys Rivera Pérez, MD
dennys.rivera@upr.edu
7877582525
Backup
Alvara J Horta Caicedo, DMD
alvaro.horta@upr.edu
1-678-394-7721
Time Frame
Start Date:2026-09
Estimated Completion Date:2027-02
Participants
Target number of participants:72
Treatments
Experimental: Intravenous Acetaminophen
Participants randomized to this arm will receive acetaminophen 1 g administered intravenously approximately 30 minutes prior to surgical incision during orthognathic surgery under general anesthesia. A second dose will be administered near the end of the surgical procedure according to the medication half-life. Postoperative pain outcomes will be compared with the other study groups.
Experimental: Intravenous Ibuprofen
Participants randomized to this arm will receive ibuprofen 600 mg administered intravenously approximately 30 minutes prior to surgical incision during orthognathic surgery under general anesthesia. A second dose will be administered near the end of the procedure according to the medication half-life. Postoperative pain outcomes will be compared with the other study groups.
No_intervention: Standard Care Control
Participants randomized to this arm will not receive preoperative analgesic medication. Postoperative pain management will follow the institution's standard care protocol after completion of the surgical procedure. Outcomes will be compared with participants receiving preemptive intravenous analgesic interventions.