Evaluation of Regional Blocks Efficacy in Orthognathic Surgery

Clinical Hospital Center Rijeka

Status: Completed

Conditions: Anesthesia

Treatments: Procedure: NaCl 0.9 %; Procedure: Levobupivakain 0.25 %

Study type: Interventional

Funder types: Other

Identifiers

NCT07133048

CHCRijeka

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups, including a placebo group

Experimental: Levobupivakain 0.25 % (Regional block)

Experimental group

Description:

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

Treatment:

Procedure: Levobupivakain 0.25 %

Placebo: NaCl 0.9% (Regional block)

Placebo Comparator group

Description:

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

Treatment:

Procedure: NaCl 0.9 %