An interventional study of Levobupivakain 0.25 % and NaCl 0.9 % in Anesthesia, sponsored by Clinical Hospital Center Rijeka. Completed at 1 site in Croatia. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-08-20.
Sponsored by Clinical Hospital Center Rijeka · Not applicable, Interventional, and Supportive care
The proposed study, which will be carried out on 72 male and female patients, who have reached bone maturity, are younger than 50 years and underwent orthognathic surgical procedures. Patients will be divided into a study group which will receive a regional block with levobupivacaine and a control group that will receive saline as a placebo. The main hypothesis is that regional analgesia in orthognathic surgery contributes to intraoperative and postoperative analgesia. The aim is to determine the real benefit of regional analgesia in orthognathic surgery and analyze the impact of psychosocial factors on results. Various psychological questionnaires, pain scale and questionnaires for evaluation of postoperative recovery will be used in the research. The results of the research could contribute to a better understanding of regional anesthesia in orthognathic surgery and determine impact of psychosocial factors on pain level and satisfaction with orthognathic surgery.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.
This study's enrollment of 72 is close to the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Clinical Hospital Center Rijeka is the lead sponsor of 19 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Participants receive regional block to II. branch of trigeminal nerve and standard intraoral block to infraorbital nerve.
Procedure: Levobupivakain 0.25 %
Participants receive regional block to II. branch of trigeminal nerve and standard intraoral block to infraorbital nerve.
Procedure: NaCl 0.9 %
The high tuberosity approach blocks for blockage of II. branch of trigeminal nerve. Standard intraoral approach for inferior alveolar nerve block.
The high tuberosity approach blocks for blockage of II. branch of trigeminal nerve. Standard intraoral approach for inferior alveolar nerve block.
The amount of analgesics given after surgery
The amount of analgesics given after surgery will be measured; patients who have more severe pain will request more analgesics
Time frame: In the first 24 hours after surgery
How mental status (catastrophizing) affects the amount of analgesics taken
Pain Catastrophizing Scale (PCS), total score ranges from 0 to 52, with higher scores indicating more severe pain catastrophizing. Number of analgesic in 24 hours.
Time frame: The day before surgery participants completed Croatian version of all psychological questionnaires. Analgesics given in the first 24 hours after surgery.
How mental status (hypervigilance) affects the amount of analgesics taken
Brief Hypervigilance Scale (BHS), range from 0 to 20, with higher scores indicating greater hypervigilance. Number of analgesics in 24 hours.
Time frame: The day before surgery participants completed Croatian version of all psychological questionnaires. Analgesics given in the first 24 hours after surgery.
How mental status (somatosensory amplification) affects the amount of analgesics taken
Somatosensory Amplification Scale (SSAS), ranges from 10 to 50, with higher scores indicating greater somatosensory amplification. Number of analgesics in 24 hours.
Time frame: The day before surgery participants completed Croatian version of all psychological questionnaires. Analgesics given in the first 24 hours after surgery.
How mental status (anxiety) affects the amount of analgesics taken
General Anxiety Disorder-7 (GAD7) scale has a total score range of 0 to 21 and scores are categorized as follows: 0-4 indicates minimal anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety, and 15-21 indicates severe anxiety.Number of analgesics in 24 hours.
Time frame: The day before surgery participants completed Croatian version of all psychological questionnaires. Analgesics given in the first 24 hours after surgery
Influence of the block on postoperative pain levels
Postoperative pain levels were assessed using the VAS scale (0-10). Higher scores indicating greater pain. The time of the most intense pain level was also examined.
Time frame: At 1 hour, 3 hours, 5 hours, 7 hours, 9 hours, 12 hours, and 24 hours after the end of the surgery.
How mental status (catastrophizing) affects the pain level.
Pain Catastrophizing Scale (PCS), total score ranges from 0 to 52, with higher scores indicating more severe pain catastrophizing. Postoperative pain levels were assessed using the VAS scale (0-10). Higher scores indicating greater pain.
Time frame: The day before surgery participants completed Croatian version of all psychological questionnaires. Pain level at 1 hour, 3 hours, 5 hours, 7 hours, 9 hours, 12 hours, and 24 hours after the end of the surgery.
How mental status (hypervigilance) affects the pain level.
Brief Hypervigilance Scale (BHS), range from 0 to 20, with higher scores indicating greater hypervigilance. Postoperative pain levels were assessed using the VAS scale (0-10). Higher scores indicating greater pain.
Time frame: The day before surgery participants completed Croatian version of all psychological questionnaires. Pain level at 1 hour, 3 hours, 5 hours, 7 hours, 9 hours, 12 hours, and 24 hours after the end of the surgery.
How mental status (somatosensory amplification) affects the pain level
Somatosensory Amplification Scale (SSAS), ranges from 10 to 50, with higher scores indicating greater somatosensory amplification. Postoperative pain levels were assessed using the VAS scale (0-10). Higher scores indicating greater pain.
Time frame: The day before surgery participants completed Croatian version of all psychological questionnaires. Pain level at 1 hour, 3 hours, 5 hours, 7 hours, 9 hours, 12 hours, and 24 hours after the end of the surgery.
How mental status (anxiety) affects the pain level
General Anxiety Disorder-7 (GAD7) scale has a total score range of 0 to 21 and scores are categorized as follows: 0-4 indicates minimal anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety, and 15-21 indicates severe anxiety. Postoperative pain levels were assessed using the VAS scale (0-10). Higher scores indicating greater pain.
Time frame: The day before surgery participants completed Croatian version of all psychological questionnaires. Pain level at 1 hour, 3 hours, 5 hours, 7 hours, 9 hours, 12 hours, and 24 hours after the end of the surgery.
How block affect on postoperative nausea and vomiting
Participants completed the simplified Postoperative nausea and vomiting (PONV) questionnaire. In this questionnaire with a 0-6 scoring system higher scores indicating more severe symptoms
Time frame: On the first postoperative day, participants completed the PONV questionnaire.
How mental status (catastrophizing) affects postoperative nausea and vomiting
Pain Catastrophizing Scale (PCS), total score ranges from 0 to 52, with higher scores indicating more severe pain catastrophizing. The simplified Postoperative nausea and vomiting (PONV) questionnaire. In this questionnaire with a 0-6 scoring system higher scores indicating more severe symptoms.
Time frame: The day before surgery participants completed Croatian version of all psychological questionnaires. On the first postoperative day, participants completed the PONV questionnaire.
How mental status (hypervigilance) affects postoperative nausea and vomiting
Brief Hypervigilance Scale (BHS), range from 0 to 20, with higher scores indicating greater hypervigilance. The simplified Postoperative nausea and vomiting (PONV) questionnaire. In this questionnaire with a 0-6 scoring system higher scores indicating more severe symptoms.
Time frame: The day before surgery participants completed Croatian version of all psychological questionnaires. On the first postoperative day, participants completed the PONV questionnaire.
How mental status affects (somatosensory amplification) postoperative nausea and vomiting
Somatosensory Amplification Scale (SSAS), ranges from 10 to 50, with higher scores indicating greater somatosensory amplification. The simplified Postoperative nausea and vomiting (PONV) questionnaire. In this questionnaire with a 0-6 scoring system higher scores indicating more severe symptoms.
Time frame: The day before surgery participants completed Croatian version of all psychological questionnaires. On the first postoperative day, participants completed the PONV questionnaire.
How mental status (anxiety) affects postoperative nausea and vomiting
General Anxiety Disorder-7 (GAD7) scale has a total score range of 0 to 21 and scores are categorized as follows: 0-4 indicates minimal anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety, and 15-21 indicates severe anxiety. The simplified Postoperative nausea and vomiting (PONV) questionnaire. In this questionnaire with a 0-6 scoring system higher scores indicating more severe symptoms.
Time frame: The day before surgery participants completed Croatian version of all psychological questionnaires. On the first postoperative day, participants completed the PONV questionnaire.
Influence of the block on the Quality of Life
We use the 36-Item Short Form Health Survey (SF-36), as a "Quality of Life" instrument. The difference in values between the tested group and the control group was examined. The SF-36 contains 36 items and measures perceived health status by assessing eight health components each scoring from 0 to 100, with higher scores indicating better health status.
Time frame: 2 days after the surgical procedure and at discharge day
Influence of the level of pain expressed on the VAS scale to the Quality of Life
Postoperative pain levels were assessed using the VAS scale (0-10). Higher scores indicating greater pain. The SF-36 contains 36 items and measures perceived health status by assessing eight health components each scoring from 0 to 100, with higher scores indicating better health status.
Time frame: VAS scale at 1 hour, 3 hours, 5 hours, 7 hours, 9 hours, 12 hours, and 24 hours after the end of the surgery. SF-36 second days after the surgical procedure and at discharge day
How mental status (catastrophizing) affects the Quality of Life
Pain Catastrophizing Scale (PCS), total score ranges from 0 to 52, with higher scores indicating more severe pain catastrophizing. The SF-36 contains 36 items and measures perceived health status by assessing eight health components each scoring from 0 to 100, with higher scores indicating better health status.
Time frame: The day before surgery participants completed Croatian version of psychological questionnaires. SF-36 second days after the surgical procedure and at discharge day.
How mental status (hypervigilance) affects the Quality of Life
Brief Hypervigilance Scale (BHS), range from 0 to 20, with higher scores indicating greater hypervigilance. The SF-36 is quality of life marker and contains 36 items and measures perceived health status by assessing eight health components each scoring from 0 to 100, with higher scores indicating better health status.
Time frame: The day before surgery participants completed Croatian version of psychological questionnaires(BHS). Second day after the surgical procedure and at discharge day (an average of third day after surgical procedure) participants completed SF-36.
How mental status (somatosensory amplification) affects the Quality of Life
Somatosensory Amplification Scale (SSAS), ranges from 10 to 50, with higher scores indicating greater somatosensory amplification. The SF-36 is quality of life marker and contains 36 items and measures perceived health status by assessing eight health components each scoring from 0 to 100, with higher scores indicating better health status.
Time frame: The day before surgery participants completed Croatian version of psychological questionnaires(SSAS). Second day after the surgical procedure and at discharge day (an average of third day after surgical procedure) participants completed SF-36.
How mental status (anxiety) affects the Quality of Life
General Anxiety Disorder-7 (GAD7) scale has a total score range of 0 to 21 and scores are categorized as follows: 0-4 indicates minimal anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety, and 15-21 indicates severe anxiety. The SF-36 is quality of life marker and contains 36 items and measures perceived health status by assessing eight health components each scoring from 0 to 100, with higher scores indicating better health status.
Time frame: The day before surgery participants completed Croatian version of psychological questionnaires(GAD7). Second day after the surgical procedure and at discharge day (an average of third day after surgical procedure)participants completed SF-36.
Influence of the block on the Quality of Recovery
The QoR-40 is marker of postoperative recovery and score ranges from 40 (indicating a poor quality of recovery) to 200 (indicating an excellent quality of recovery).
Time frame: The first day after the surgical procedure and at discharge day (an average of third day after surgical procedure) participants completed Croatian version of QoR-40 questionnaire.
Influence of the block on the satisfaction with the surgical procedure
For a general assessment of satisfaction with the surgical procedure, the Surgical Satisfaction Questionnaire (SSQ-8) was used.SSQ-8 ranges from 0 to 100, where 100 represents the highest level of satisfaction
Time frame: Two months after the surgical procedure, the patient completed the SSQ-8 questionnaire.
Influence of the level of pain expressed on the VAS scale to the Quality of Recovery (QoR-40)
Postoperative pain levels were assessed using the VAS scale (0-10). Higher scores indicating greater pain. The QoR-40 score ranges from 40 (indicating a poor quality of recovery) to 200 (indicating an excellent quality of recovery).
Time frame: VAS scale at 1 hour, 3 hours, 5 hours, 7 hours, 9 hours, 12 hours, and 24 hours after the end of the surgery. Second day after the surgical procedure and at discharge day (an average of third day after surgical procedure) participants completed QoR-40.
How mental status (catastrophizing) affects the Quality of Recovery
Pain Catastrophizing Scale (PCS), total score ranges from 0 to 52, with higher scores indicating more severe pain catastrophizing. The QoR-40 score ranges from 40 (indicating a poor quality of recovery) to 200 (indicating an excellent quality of recovery).
Time frame: The day before surgery participants completed Croatian version of psychological questionnaire (PCS). Second day after the surgical procedure and at discharge day (an average of third day after surgical procedure) participants completed QoR-40.
How mental status (hypervigilance) affects the Quality of Recovery
Brief Hypervigilance Scale (BHS), range from 0 to 20, with higher scores indicating greater hypervigilance. The QoR-40 score ranges from 40 (indicating a poor quality of recovery) to 200 (indicating an excellent quality of recovery).
Time frame: The day before surgery participants completed Croatian version of all psychological questionnaires (BHS). Second day after the surgical procedure and at discharge day (an average of third day after surgical procedure) participants completed QoR-40.
How mental status (somatosensory amplification) affects the Quality of Recovery
Somatosensory Amplification Scale (SSAS), ranges from 10 to 50, with higher scores indicating greater somatosensory amplification. The QoR-40 score ranges from 40 (indicating a poor quality of recovery) to 200 (indicating an excellent quality of recovery).
Time frame: The day before surgery participants completed Croatian version of psychological questionnaires (SSAS). Second day after the surgical procedure and at discharge day (an average of third day after surgical procedure) participants completed QoR-40.
How mental status (anxiety) affects the Quality of Recovery
General Anxiety Disorder-7 (GAD7) scale has a total score range of 0 to 21 and scores are categorized as follows: 0-4 indicates minimal anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety, and 15-21 indicates severe anxiety. The QoR-40 score ranges from 40 (indicating a poor quality of recovery) to 200 (indicating an excellent quality of recovery).
Time frame: The day before surgery participants completed Croatian version of psychological questionnaires (GAD7). Second day after the surgical procedure and at discharge day (an average of third day after surgical procedure) participants completed QoR-40.
Influence of the level of pain expressed on the VAS scale to the satisfaction with the surgical procedure
Postoperative pain levels were assessed using the VAS scale (0-10). Higher scores indicating greater pain. For a general assessment of satisfaction with the surgical procedure, the Surgical Satisfaction Questionnaire (SSQ-8) was used.SSQ-8 ranges from 0 to 100, where 100 represents the highest level of satisfaction.
Time frame: VAS scale at 1 hour, 3 hours, 5 hours, 7 hours, 9 hours, 12 hours, and 24 hours after the end of the surgery. Two months after the surgical procedure, the patient completed the SSQ-8 questionnaire.
How mental status (catastrophizing) affects the satisfaction with the surgical procedure
Pain Catastrophizing Scale (PCS), total score ranges from 0 to 52, with higher scores indicating more severe pain catastrophizing. For a general assessment of satisfaction with the surgical procedure, the Surgical Satisfaction Questionnaire (SSQ-8) was used.SSQ-8 ranges from 0 to 100, where 100 represents the highest level of satisfaction
Time frame: The day before surgery participants completed Croatian version of psychological questionnaires. Two months after the surgical procedure, the patient completed the SSQ-8 questionnaire.
How mental status (hypervigilance) affects the satisfaction with the surgical procedure
Brief Hypervigilance Scale (BHS), range from 0 to 20, with higher scores indicating greater hypervigilance. For a general assessment of satisfaction with the surgical procedure, the Surgical Satisfaction Questionnaire (SSQ-8) was used.SSQ-8 ranges from 0 to 100, where 100 represents the highest level of satisfaction
Time frame: The day before surgery participants completed Croatian version of psychological questionnaires. Two months after the surgical procedure, the patient completed the SSQ-8 questionnaire.
How mental status (somatosensory amplification) affects the satisfaction with the surgical procedure
Somatosensory Amplification Scale (SSAS), ranges from 10 to 50, with higher scores indicating greater somatosensory amplification. For a general assessment of satisfaction with the surgical procedure, the Surgical Satisfaction Questionnaire (SSQ-8) was used.SSQ-8 ranges from 0 to 100, where 100 represents the highest level of satisfaction
Time frame: The day before surgery participants completed Croatian version of psychological questionnaires. Two months after the surgical procedure, the patient completed the SSQ-8 questionnaire.
How mental status (anxiety) affects the satisfaction with the surgical procedure
General Anxiety Disorder-7 (GAD7) scale has a total score range of 0 to 21 and scores are categorized as follows: 0-4 indicates minimal anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety, and 15-21 indicates severe anxiety. For a general assessment of satisfaction with the surgical procedure, the Surgical Satisfaction Questionnaire (SSQ-8) was used.SSQ-8 ranges from 0 to 100, where 100 represents the highest level of satisfaction
Time frame: The day before surgery participants completed Croatian version of psychological questionnaires. Two months after the surgical procedure, the patient completed the SSQ-8 questionnaire.
The length of hospital stay after the surgical procedure
Number of days spent in hospital after the procedure
Time frame: The day count starts from the first postoperative day until the day of discharge from the hospital day (an average of third day after surgical procedure).
Complications and side effects
All complication of surgery and preemptive block
Time frame: Recording of complications begins from the time the regional block is administered until the day of discharge from the hospital day (an average of third day after surgical procedure).
Plan to share: Yes — All data included in the research can be shared. Except for the personal data of the participants.
Supporting information: Icf
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Clinical Hospital Center Rijeka