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NCT Number: NCT07133048

Evaluation of Regional Blocks Efficacy in Orthognathic Surgery

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.

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Key information

Conditions

Anesthesia Nausea Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic for Maxillofacial surgery

Rijeka, Croatia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • bone deformities for which one of the following surgical procedures is performed: bimaxillary osteotomy, bimaxillary osteotomy with genioplasty, isolated Le Fort I osteotomy, or isolated sagittal osteotomy of the mandible
  • patients who have reached skeletal maturity and are under 50 years of age
  • patient classified as ASA I and ASA II (American Society of Anesthesiologists).

Exclusion criteria

  • known allergy to local anesthetics
  • refusal to participate in the study
  • patients with a cleft of the primary and/or secondary palate
  • patients with craniofacial syndromes
  • patients who have undergone surgical revision for any reason

Treatment and study plan

Levobupivakain 0.25 %

Procedure

The high tuberosity approach blocks for blockage of II. branch of trigeminal nerve.

Standard intraoral approach for inferior alveolar nerve block.

NaCl 0.9 %

Procedure

The high tuberosity approach blocks for blockage of II. branch of trigeminal nerve.

Standard intraoral approach for inferior alveolar nerve block.

Primary outcomes

  1. The amount of analgesics given after surgery

    Time frame: In the first 24 hours after surgery

    The amount of analgesics given after surgery will be measured; patients who have more severe pain will request more analgesics

Secondary outcomes

  1. How mental status (catastrophizing) affects the amount of analgesics taken

    Time frame: The day before surgery participants completed Croatian version of all psychological questionnaires. Analgesics given in the first 24 hours after surgery.

    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.

  2. How mental status (hypervigilance) affects the amount of analgesics taken

    Time frame: The day before surgery participants completed Croatian version of all psychological questionnaires. Analgesics given in the first 24 hours after surgery.

    Brief Hypervigilance Scale (BHS), range from 0 to 20, with higher scores indicating greater hypervigilance. Number of analgesics in 24 hours.

  3. How mental status (somatosensory amplification) affects the amount of analgesics taken

    Time frame: The day before surgery participants completed Croatian version of all psychological questionnaires. Analgesics given in the first 24 hours after surgery.

    Somatosensory Amplification Scale (SSAS), ranges from 10 to 50, with higher scores indicating greater somatosensory amplification. Number of analgesics in 24 hours.

  4. How mental status (anxiety) affects the amount of analgesics taken

    Time frame: The day before surgery participants completed Croatian version of all psychological questionnaires. Analgesics given in the first 24 hours after surgery

    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.

  5. Influence of the block on postoperative pain levels

    Time frame: At 1 hour, 3 hours, 5 hours, 7 hours, 9 hours, 12 hours, and 24 hours after the end of the surgery.

    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.

  6. How mental status (catastrophizing) affects the pain level.

    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.

    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.

  7. How mental status (hypervigilance) affects the pain level.

    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.

    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.

  8. How mental status (somatosensory amplification) affects the pain level

    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.

    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.

  9. How mental status (anxiety) affects the pain level

    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.

    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.

  10. How block affect on postoperative nausea and vomiting

    Time frame: On the first postoperative day, participants completed the PONV questionnaire.

    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

  11. How mental status (catastrophizing) affects postoperative nausea and vomiting

    Time frame: The day before surgery participants completed Croatian version of all psychological questionnaires. On the first postoperative day, participants completed the PONV questionnaire.

    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.

  12. How mental status (hypervigilance) affects postoperative nausea and vomiting

    Time frame: The day before surgery participants completed Croatian version of all psychological questionnaires. On the first postoperative day, participants completed the PONV questionnaire.

    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.

  13. How mental status affects (somatosensory amplification) postoperative nausea and vomiting

    Time frame: The day before surgery participants completed Croatian version of all psychological questionnaires. On the first postoperative day, participants completed the PONV questionnaire.

    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.

  14. How mental status (anxiety) affects postoperative nausea and vomiting

    Time frame: The day before surgery participants completed Croatian version of all psychological questionnaires. On the first postoperative day, participants completed the PONV questionnaire.

    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.

  15. Influence of the block on the Quality of Life

    Time frame: 2 days after the surgical procedure and at discharge day

    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.

  16. Influence of the level of pain expressed on the VAS scale to the Quality of Life

    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

    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.

  17. How mental status (catastrophizing) affects the Quality of Life

    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.

    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.

  18. How mental status (hypervigilance) affects the Quality of Life

    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.

    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.

  19. How mental status (somatosensory amplification) affects the Quality of Life

    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.

    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.

  20. How mental status (anxiety) affects the Quality of Life

    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.

    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.

  21. Influence of the block on the 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.

    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).

  22. Influence of the block on the satisfaction with the surgical procedure

    Time frame: Two months after the surgical procedure, the patient completed the SSQ-8 questionnaire.

    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

  23. Influence of the level of pain expressed on the VAS scale to the Quality of Recovery (QoR-40)

    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.

    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).

  24. How mental status (catastrophizing) affects the 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.

    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).

  25. How mental status (hypervigilance) affects the 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.

    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).

  26. How mental status (somatosensory amplification) affects the 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.

    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).

  27. How mental status (anxiety) affects the 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.

    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).

  28. Influence of the level of pain expressed on the VAS scale to the satisfaction with the surgical procedure

    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.

    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.

  29. How mental status (catastrophizing) affects the satisfaction with the surgical procedure

    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.

    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

  30. How mental status (hypervigilance) affects the satisfaction with the surgical procedure

    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.

    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

  31. How mental status (somatosensory amplification) affects the satisfaction with the surgical procedure

    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.

    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

  32. How mental status (anxiety) affects the satisfaction with the surgical procedure

    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.

    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

Other outcomes

  1. The length of hospital stay after the surgical 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).

    Number of days spent in hospital after the procedure

  2. Complications and side effects

    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).

    All complication of surgery and preemptive block

Sponsors and collaborators

Lead sponsor

Clinical Hospital Center Rijeka

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Aug 20, 2025
Registry last updated
Aug 20, 2025

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View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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