Evaluation of Regional Blocks Efficacy in Orthognathic Surgery

NCT07133048 | Completed

• 1 other identifier: CHCRijeka
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

anesthesia, conduction;; nerve block;; orthognathic surgery;; pain, postoperative;; postoperative nausea and vomiting;; psychosocial factors

Outcome Measures

Primary Outcomes (1)

• 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

  In the first 24 hours after surgery

Secondary Outcomes (32)

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

  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

  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

  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

  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

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

Other Outcomes (2)

• The length of hospital stay after the surgical procedure

  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

  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).

Study Arms (2)

Experimental: Levobupivakain 0.25 % (Regional block)

EXPERIMENTAL

Participants receive regional block to II. branch of trigeminal nerve and standard intraoral block to infraorbital nerve.

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.

Procedure: NaCl 0.9 %

Interventions

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.

Experimental: Levobupivakain 0.25 % (Regional 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.

Placebo: NaCl 0.9% (Regional block)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Hospital Center Rijeka: lead

Study Sites (1)

Clinic for Maxillofacial surgery

Rijeka, Croatia

Location

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: August 20, 2025
• Study Start: March 2, 2020
• Primary Completion: September 2, 2022
• Study Completion: December 2, 2023
• Last Updated: August 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF

Locations

CR (1)