Effects of Ultrasound-guided Maxillary Nerve Block Performed After Bimaxillary Osteotomy in Adult Patients
NCT Number: NCT06460051
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Maxillary Diseases|Pain, Postoperative|Adult Patients Undergoing Bimaxillary Osteotomy
Interventions: PROCEDURE: Maxillary nerve block
Sponsor: Gloria Molins Ballabriga
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2024-09
Locations: Servei Central d'Anestesiologia Centro Medico Teknon, Barcelona, 08034, Spain

Summary:
Bimaxillary osteotomy is a surgery procedure of the orthognathic surgery field for correction of dental and facial abnormalities, for both functional and aesthetic cases. The incidence of this abnormality is 5-10% of the population, and the etiology is unknown, with genetic, environmental and embryonic factors related. The surgery technic is complex, and requires osteotomy of the maxilla and jaw, which allows toward, forward, impact and rotation of these bones to fix the edges of the face. The anesthetic management of these patients is a challenge because of the difficult airway management and the perioperative pain control. Multimodal approach for pain control is a fact, and the use of local and regional anaesthesia is mandatory. The investigators propose bilateral ultrasound-guided suprazigomatic maxillary nerve block after bimaxillary osteotomy for a proper control of postoperative pain.

Primary Outcome Measures: Inmediate Postoperative pain, Postoperative pain in patients undergoing elective bimaxillary osteotomy, evaluated using the visual analog pain scale in the immediate postoperative period (2 hours postoperative). VAS: Visual analogue scale (0=minimum pain - 10=maximum pain), 2 hours postoperatively
Secondary Outcome Measures: Pain at 8 hours postoperatively, Pain in patients undergoing elective bimaxillary osteotomy, evaluated using the visual analog pain scale at 8 hours postoperatively. VAS: Visual analogue scale (0=minimum pain - 10=maximum pain), 8 hours postoperatively|Pain 18 hours after surgery, Pain in patients undergoing elective bimaxillary osteotomy, evaluated using the visual analog pain scale at 18 hours postoperatively. VAS: Visual analogue scale (0=minimum pain - 10=maximum pain), 18 hours postoperatively|Inmediate Use of Opioids, Use of rescue opioids (milligrams of methadone) in the immediate postoperative period in resuscitation ward (milligrams of intravenous methadone at 2 hours postoperatively), 2 hours postoperatively|Use of rescue opioids from 2 to 18 hours postoperatively, Use of rescue oipoids in the hospitalization ward (milligrams of subcutaneous methadone from 2 to 18 hours postoperatively), 2 to 18 hours postoperatively|Incidence of immediate postoperative nausea and vomiting, Incidence of immediate postoperative nausea and vomiting (PONV) in resuscitation ward (2 hours postoperatively), 2 hours postoperatively|Incidence of postoperative nausea and vomiting up to 18 hours postoperatively, Incidence of postoperative nausea and vomiting up to 18 hours postoperatively, 18 hours postoperatively