Effects of Local Ketamine in Orthognathic Procedures

Not Applicable

Active, not recruiting

• Conditions: Dentofacial Deformities; Vomiting, Postoperative; Nausea, Postoperative; Analgesia
• Interventions: Drug: Ketamine; Drug: Articaine Hydrochloride + Epinephrine

• Registration Number: NCT07066306
• Lead Sponsor: Bezmialem Vakif University

Brief 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.

Detailed Description

Orthognathic surgery is performed to correct congenital or developmental anomalies of the maxilla and mandible, as well as secondary deformities caused by trauma. These procedures require multiple incisions, dissections, and osteotomies in both the maxilla and mandible. The acute postoperative pain that follows orthognathic surgery is primarily the result of these surgical traumas and the subsequent inflammatory process. As tissue healing progresses, postoperative pain gradually subsides. This type of pain is one of the primary factors affecting postoperative recovery, return to function, and length of hospital stay.

Many studies have focused on achieving optimal analgesia during this period, which significantly affects patients' postoperative quality of life. For this purpose, several agents have been used, including non-steroidal anti-inflammatory drugs (NSAIDs), opioids, non-opioid analgesics (such as acetaminophen), NMDA receptor antagonists, and long-acting local anesthetics.

Ketamine is a well-known general anesthetic and short-acting intraoperative analgesic agent with established pharmacodynamic and pharmacokinetic profiles and known side effects. Ketamine is a non-selective antagonist of supraspinal N-methyl-D-aspartate (NMDA) receptors. It is believed that inhibition of these receptors reduces neuronal excitation and produces analgesia through this mechanism. Ketamine's interactions with spinal pain receptors and opioid receptors are also thought to contribute to its analgesic effects.

In low doses, ketamine has been evaluated for local analgesic purposes in combination with local anesthetics in various surgical procedures, aiming to minimize side effects. Cleft palate repair and third molar extractions are among the oral surgery procedures where the local analgesic efficacy of ketamine has been investigated. In a study by Jha et al. on cleft palate repair, the authors examined the effects of local bupivacaine combined with ketamine on postoperative nausea, vomiting, dysphagia, and sleep patterns. They found that patients in the ketamine group had superior outcomes in terms of reduced need for additional analgesia, improved sleep, and earlier return to feeding.

Similarly, Satılmış et al. reported significant reductions in postoperative pain, swelling, and trismus in third molar extraction patients when sub-anesthetic doses of ketamine were combined with local anesthetics. Shah et al. also observed that combining ketamine with local anesthetics during third molar extraction reduced postoperative pain and swelling compared to local anesthetics alone.

To date, there are no studies in the literature investigating the effects of combining ketamine with local anesthetics in orthognathic surgery. Therefore, this study was designed to address this gap.

Study Timeline

• Study Start: 2025-06-21
• Study First Submitted: 2025-06-23
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-03
• Last Update Submitted: 2025-07-03
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15
• Primary Completion: 2025-12-10
• Study Completion: 2025-12-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
local ketamine group	Ketamine	Following induction of general anesthesia, 0.2 mg/kg of ketamine will be locally administered in place of standard local anesthetic in this group
control group	Articaine Hydrochloride + Epinephrine	Following induction of general anesthesia, standard local anesthetic (articaine) will be locally administered in this group

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
nausea and vomiting	3 days	after the operation we assess the nausea and vomiting every 2 hours interval and score it in 4 point scale; Nausea and Vomiting Scoring System: 0 = No nausea; 1. = Nausea only; 2. = Nausea accompanied by retching; 3. = Vomiting

Trial Locations

Locations (1)

Bezmialem Vakıf Universty; 🇹🇷 Istanbul, Fatih, Turkey