AnesthesiaNCT07133048
Evaluation of Regional Blocks Efficacy in Orthognathic Surgery
A study testing Levobupivakain 0.25 % and NaCl 0.9 % in people with Anesthesia, run by Clinical Hospital Center Rijeka at 1 site in Croatia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Levobupivakain 0.25 % and NaCl 0.9 %
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteCroatia
- Study dates
- 2 Mar 2020to 2 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Anesthesia
- Being tested
- Levobupivakain 0.25 %, NaCl 0.9 %
- Keywords
- anesthesia, conduction;, nerve block;, orthognathic surgery;, pain, postoperative;, postoperative nausea and vomiting;, psychosocial factors
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levobupivakain 0.25 %Procedure or surgery
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 or surgery
The high tuberosity approach blocks for blockage of II. branch of trigeminal nerve.
Standard intraoral approach for inferior alveolar nerve block.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Levobupivakain 0.25 % (Regional block) | Experimental | Participants receive regional block to II. branch of trigeminal nerve and standard intraoral block to infraorbital nerve. Receives: Procedure: Levobupivakain 0.25 % |
| Placebo: NaCl 0.9% (Regional block) | Placebo comparator | Participants receive regional block to II. branch of trigeminal nerve and standard intraoral block to infraorbital nerve. Receives: Procedure: NaCl 0.9 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: In the first 24 hours after surgery
Secondary outcomes (32)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: The day before surgery participants completed Croatian version of psychological questionnaires. Two months after the surgical procedure, the patient completed the SSQ-8 questionnaire.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start2 Mar 2020
- Primary completion2 Sep 2022
- Study completion2 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Center Rijeka
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Harmicar, Clinical Hospital Center Rijeka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133048
- Sponsor's protocol ID
- CHCRijeka
- Status last verified
- Jul 2025
- First submitted
- 25 Jun 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data included in the research can be shared. Except for the personal data of the participants.
Publications
Harmicar D, Belusic M, Goles Jurisa A, Zupan Z, Zubovic A, Cerovic R. The true benefit of the regional block in orthognathic surgery lies in the preemptive effect. Oral Maxillofac Surg. 2026 Mar 6;30(1):47. doi: 10.1007/s10006-026-01522-y.
PubMed 41790271
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Regional Blocks Efficacy in Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT07133048
- Acronym / sponsor ID
- CHCRijeka
- Conditions
- Anesthesia
- Keywords
- anesthesia, conduction;, nerve block;, orthognathic surgery;, pain, postoperative;, postoperative nausea and vomiting;, psychosocial factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Clinical Hospital Center RijekaUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Dec 2023 (actual)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Levobupivakain 0.25 % (Regional block) | Experimental | Procedure: Levobupivakain 0.25 %Participants receive regional block to II. branch of trigeminal nerve and standard intraoral block to infraorbital nerve. |
| Placebo: NaCl 0.9% (Regional block) | Placebo comparator | Procedure: NaCl 0.9 %Participants receive regional block to II. branch of trigeminal nerve and standard intraoral block to infraorbital nerve. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levobupivakain 0.25 %The high tuberosity approach blocks for blockage of II. branch of trigeminal nerve. Standard intraoral approach for inferior alveolar nerve block. | Procedure or surgery | Experimental: Levobupivakain 0.25 % (Regional block) |
| NaCl 0.9 %The high tuberosity approach blocks for blockage of II. branch of trigeminal nerve. Standard intraoral approach for inferior alveolar nerve block. | Procedure or surgery | Placebo: NaCl 0.9% (Regional block) |
Primary outcome
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
32 secondary outcomes
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.
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.
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.
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
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.
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.
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.
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.
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.
How block affect on postoperative nausea and vomiting
Time frame: On the first postoperative day, participants completed the PONV questionnaire.
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.
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.
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.
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.
Influence of the block on the Quality of Life
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
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
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
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
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
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
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
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)
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
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
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
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
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
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
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
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Derived from this study: PubMed 41790271Harmicar D, Belusic M, Goles Jurisa A, Zupan Z, Zubovic A, Cerovic R. The true benefit of the regional block in orthognathic surgery lies in the preemptive effect. Oral Maxillofac Surg. 2026 Mar 6;30(1):47. doi: 10.1007/s10006-026-01522-y.
- Individual participant dataSharing planned: Yes. All data included in the research can be shared. Except for the personal data of the participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levobupivakain 0.25 % and NaCl 0.9 % in people with Anesthesia, run by Clinical Hospital Center Rijeka at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of analgesics given after surgery (time frame: In the first 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07133048, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.