Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21-65
SponsorUniversity of Puerto Rico

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Acetaminophen
  • ibuprofen

Treatment groups

72 Participants
are divided into 3 treatment groups

Locations

1
Administración de Servicios Médicos (ASEM)00936, San Juan Puerto Rico

Sponsors and collaborators

University of Puerto Rico

Lead sponsor