Ketamine: In the ketamine group, 0.2 mg/kg of ketamine will be administered locally. This application will be performed twice: once during the Le Fort I osteotomy and once during the sagittal split osteotomy. After calculating the total dose, it will be equally divided and administered locally to both the maxilla and the mandible.
Articaine Hydrochloride + Epinephrine: A total of 4 ampoules of articaine hydrochloride will be used. Two ampoules will be administered prior to the incision during the Le Fort I osteotomy, and the remaining two ampoules will be used prior to the incision during the sagittal split osteotomy.
Study summary
Orthognathic surgery is performed to correct congenital, developmental, or trauma-related skeletal deformities of the maxilla and mandible. These procedures involve multiple incisions, dissections, and osteotomies, leading to significant postoperative inflammatory responses and acute pain. Postoperative pain is a key factor influencing recovery, return to function, and length of hospital stay.
Various analgesics have been used to manage pain after orthognathic surgery, including NSAIDs, opioids, acetaminophen, NMDA receptor antagonists, and long-acting local anesthetics. Ketamine is a well-known NMDA receptor antagonist with both central and peripheral analgesic effects. In subnesthetic doses, ketamine has been evaluated in various surgical fields for its potential to enhance analgesia when combined with local anesthetics, while minimizing systemic side effects.
Studies have shown that local ketamine administration during cleft palate repair and third molar extractions can significantly reduce postoperative pain, swelling, and trismus. However, to date, no studies have investigated the effects of locally administered ketamine in orthognathic surgery. Therefore, this study was designed to evaluate the intraoperative and postoperative effects of local ketamine injection in this context.
Eligibility
Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
Inclusion Criteria:
1. Patients with Class II or Class III skeletal deformities who underwent bimaxillary orthognathic surgery due to dentofacial deformities.
2. ASA I-II physical status patients.
3. Patients aged between 18 and 45 years.
4. Patients who received anesthesia induction and maintenance with propofol (0.2-0.6 mg/kg/hour) titrated to maintain an entropy score between 40-60, and remifentanil (0.05-0.5 mg/kg/hour) adjusted to maintain a Surgical Pleth Index (SPI) between 20-50.
5. Patients who received a combination of local anesthetic and ketamine.
6. Patients who were administered patient-controlled analgesia (PCA) at the end of the surgery and whose opioid consumption via PCA was monitored during the first 24 hours postoperatively.
7. Patients whose nausea-vomiting scores and need for antiemetics were recorded.
8. Patients with complete documentation of anesthesia records, including entropy scores, SPI values, and total doses of propofol and remifentanil administered.
9. Patients with completed postoperative edema follow-up forms.
Exclusion Criteria:
1. Patients with a known allergy to ketamine.
2. Patients with uncontrolled systemic diseases.
3. Patients using psychotropic medications.
4. Patients with a history of substance abuse.
5. Patients with chronic pain lasting longer than 3 months.
6. Patients using analgesic or hypnotic medications for more than 2 weeks.
7. Cases in which complications occurred during surgery that required deviation from the standard orthognathic surgical protocol and could potentially affect postoperative pain levels (e.g., bad split, unexpectedly prolonged surgical duration, etc.).
Primary outcome measure(s)
rescue analgesia dose — 2 days In the postoperative period, in addition to the standard pain management protocol, the need for rescue analgesia will be recorded by calculating the total administered dose. For rescue analgesia, 50 mg of tramadol will be delivered via infusion pump and administered through patient-controlled analgesia (PCA).
postoperative edema calculation for the first 1-3 and 7 day (cm) — 7 days the first secondary outcome of this study is post operative edema: Prior to anesthesia induction, Tragus (Tra) and Gonion (Go) points were marked with methylene blue, and distances including Lateral Canthus - Gonion, Tragus-Commissure, and interincisal distances were measured with a paper ruler and recorded as preoperative measurements.Measurements of Lateral Canthus - Gonion, Tragus-Commissure, and Interincisal distances were repeated on postoperative days 1, 3, and 7 for evaluating postoperative edema.
Visual analogue scale — 2 days Author asses the pain score with visual analogue scale (VAS) every 2 hours interval with 2. days. Higher scores means patients feel more pain and lower scores mean patients feel low pain. minımum score is 0, and maximum is 100.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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