This cohort study was designed by the researchers as a single-center, prospective, controlled, randomized, and double-blind study. Ethical approval for this study was obtained from the Erciyes University Human Research Ethics Committee. This study was performed on patients who had undergone double jaw surgery to correct Class III skeletal deformity between 2017 and 2019 in Erciyes University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery. The number of samples was calculated using the Cohen approach to have 80% power and 0.05 error. Based on this calculation, it was decided to include 15 patients in the study. All the volunteers were informed about the drugs, surgical procedure, possible side effects and complications and written informed consent was obtained. Informed consent was obtained from all individual participants included in the study. Patients signed informed consent regarding publishing their data and photographs.
Inclusion criteria for this study were as follows; patients 18-45-year-olds, ASA I status, Class III malocclusion, elective double jaw surgery. Exclusion criteria were ASA II and above, drug allergy, liver and kidney failure, pregnant or breastfeeding, long-term use of pain relievers such as NSAIDs and opioids, diabetes.
The primary predictor variable was preventive analgesia group. Patients were randomly divided in two groups. 50 mg IV dexketoprofen trometamol (Arveles 50mg/2mL; UFSA, İstanbul, Turkey) were administrated 30 minutes before incision in the treatment group (deksketoprofen trometamol n= 15) and IV sterile saline were administrated 30 minutes before incision in the placebo group (saline n= 15). Before the operation, all patients were informed about the use of patient control analgesia (PCA) device and VAS (Visual Analog Scale). In order to provide double blindness different researchers performed preventive medication and evaluation of the postoperative edema and pain.
Demographic and operation related parameters possibly associated with postoperative pain and swelling were recorded. Demographic variable was age, gender and weight. Operation related variable were amount of movement of upper and lower jaw, amount of bleeding, duration of surgery and vomiting.
The postoperative pain, swelling and 24-hour opioid intake were primary outcomes. The postoperative pain was assessed using a 10-cm visual analogue scale (VAS) at postoperative 1st, 3rd, 6th, 9th, 12th and 24th hours. Complications such as nausea, vomiting, rash, itching were also noted.
3dMD Face System (3dMD, ATLANTA, GA, USA) was used for 3D imaging of postoperative swelling. The same clinician took the 3D images from patients in natural head position, maximum intercuspation and eyes open. 3D images were taken one (T0) day before surgery and 1 (T1), 3 (T3), 7 (T7), 14 (T14), 21 (T21), 30 (T30), 90 (T90) day after surgery. The 3dMD Vultus Software (3dMD, Atlanta, GA) was used to analyse the images. The 3-month postoperative 3D image (t90) was selected as the reference image to compare with other images. After cutting and customizing the images by anatomical structures, scans t0-t30 were matched to the reference scan t90. The forehead, nasion, tragus, medial and lateral canthus were used for surface matching. After surface matching, the volume difference between the masks was calculated (Figure 1).
Secondary outcomes were rescue analgesic requirement and relationship between bleeding, duration of surgery, pain and swelling.
8 mg ondansetron (Ondaren of 4 mg / 2 mL, VEM, Istanbul, Turkey), 2 mg midazolam (Demizolam, Dem İlaç San. Tic. Ltd. Şti. Istanbul, Turkey), were administered to all patients as a premedication 30 minutes before the operation. For antibiotic prophylaxis iv 2 gr ampicillin + sulbactam (Alfacid Im/Iv, Yavuz İlaç Ecza Deposu, Istanbul, Turkey) was given all patient 30 minnute before operation.
The same surgical team in Erciyes University Oral and Maxillofacial Surgery Hospital operated all patients. Anesthesia induction was performed in both groups by IV 2 mg/kg propofol (Propofol®, Fresenius Kabi, Germany) and IV 0.6 mg/kg rocuronium (Esmeron®, Glaxosmithkline, UK). Patients were intubated with nasotracheal approach. 0.1 mg/kg rocuronium was given for muscle relaxation during the operation whenever necessary. Maintenance of anesthesia was provided by 1.5% sevofluran (Sevorane®, Abbott, USA) and 50 μg /h fentanyl, 50% N2O in oxygen, 50% O2 for air. (Tidal Volume= 6 8mL/kg, Frequency =10/mins). During the operation, 1μcg/kg fentanyl was made when require an additional analgesia. The inferior alveolar, buccal and lingual block were performed with 80 mg %2 articaine in addition to 1:200.000 epinephrine (Ultracain®%2 Ampoule, Sanofi Aventis, Istanbul, Turkey) to all patients before surgery. Le fort I (LFI) osteotomy and Bilateral Sagittal Split Osteotomy (BSSO) was performed according to Bell and Hunsuck modification. 1mg neostigmine (Neostigmin® Ampoule 0.5mg/mL, Adeka, Samsun, Turkey) and 0.5mg atropine (Atropine Sulphate® Ampoule 0.5mg/mL, Galen, Istanbul, Turkey) were administered for antagonism of the muscle relaxant when the surgical process was finished. Duration of surgery, total amount of intraoperative bleeding and complications were recorded. The patient extubated and transferred to the post anaesthetics care unit (PACU).
Pressure elastic patches were applied to the patients to include lip, cheek and submandibular areas for edema control. All the patients received iv tramadol (Contramal 100 mg, Abdi İbrahim, İstanbul, Turkey) with PCA device (Abbott Pain Management Provider, Chicago, IL) at postoperative care unit. The PCA device was adjusted to have a loading dose of 50 mg, a bolus dose of 10 mg, a 30-minute lock-in time, no basal infusion, and a 4-hour restriction. When the VAS pain score is 4 and/or higher than 4, rescue analgesia was provided by iv 1000 mg paracetamol (Perfalgan 10 mg/mL 100 mL, Bristol-Myers Squibb, İstanbul, Turkey)
The normal distribution of the data was evaluated by histogram, q-q graphs and Shapiro-Wilk test. The homogeneity of variance was tested by the Levene test. In the comparisons between the two groups, two independent samples t test and Mann Whitney U tests were used for the quantitative variables. The relationship between quantitative variables was evaluated by Spearman correlation analysis. Pearson m2 analysis was used to compare categorical data. The Friedman test was used for time comparisons. Dunn test was used for multiple comparisons. Data analysis TURCOSA Statistics Software (Turcosa Analytical Ltd. Co., is www.turcosa.com.t Turkey) was held at the statistics software. Significance level was accepted as p <0.05.