Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Acetaminophen
DrugAcetaminophen 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.
ibuprofen
DrugIbuprofen 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 surgical procedure according to the medication half-life.
Treatment groups
72 Participants
are divided into 3 treatment groupsGroup A: Intravenous AcetaminophenExperimental treatment 1 intervention
Group B: Intravenous IbuprofenExperimental treatment 1 intervention
Group C: Standard Care ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Postoperative Pain Intensity
Postoperative pain intensity measured using a validated pain scale (Visual Analog Scale, 0-10) in patients undergoing orthognathic surgery. Pain scores will be recorded and compared between the acetaminophen, ibuprofen, and control groups.
Time frame
1 hour, 4 hours, and 24 hours after surgerySecondary outcomes
1
Postoperative Analgesic Consumption
Total amount of rescue analgesic medications administered during the postoperative period will be recorded and compared between study groups.
Time frame
Within 24 hours after surgery2
Patient Satisfaction with Pain Management
Patient satisfaction with postoperative pain control measured using the Spanish version of the Pain Treatment Satisfaction Scale (PTSS).
Time frame
24 hours after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov