Effects of Ultrasound-guided Maxillary Nerve Block Performed After Bimaxillary Osteotomy in Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Inmediate Postoperative pain
研究概览
简要总结
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.
详细描述
Bimaxillary osteotomy is a surgical procedure in the field of orthognathic surgery (from Latin; "orthos" rectum and "gnathos" mandible) for the correction of dentofacial deformities, both for functional and aesthetic reasons. The incidence of this deformity is estimated to be in the order of 5-10% of the population; and its origin is still unknown, and genetic, environmental and embryonic factors are postulated. The surgical technique is complex, with the performance of mandibular and upper jaw osteotomies that allow these bones to be advanced, retracted, impacted and rotated, to align the facial axes. For all these reasons, the anesthetic management of these patients is a challenge. First, the foreseeable difficulty of managing the patient's airway; and second, the control of the patient's pain in the perioperative period.
Therefore, it is said that bimaxillary osteotomy is a frequent and potentially painful surgery in adults. Bimaxillary surgery under general anesthesia is common practice. And isolated non-ultrasound-guided peripheral nerve blocks and surgical field infiltration are widely used practices by surgeons. These minor blockages and infiltrations are used to avoid the unwanted effects of anesthetics and analgesics; particularly the adverse respiratory effects of opioids. The practice of loco-regional anesthesia therefore provides perioperative pain control in a multimodal way, showing effective postoperative analgesia and minimizing respiratory depression due to excessive use of opioids.
The introduction of loco-regional nerve blocks in the last three decades has meant a revolution in the management and control of perioperative pain for the anesthesiologist. The expansion of the practice of loco-regional nerve blocks has been seen in both the upper and lower limbs, as well as the trunk and abdomen. Conversely, facial blocks, superficial and deep, have not experienced the same; relegating its practice to the surgeon, or to the anesthesiologist who works in the field of chronic pain. The subsequent introduction of ultrasonography (USG) in the 1990s in the perioperative period was also an important advance for the anesthesiologist, both in terms of safety and in terms of ease of handling catheterizations of the venous and arterial lines, and the practice of loco-regional blocks.
Consequently, anesthesiologists already experienced at the USG have recently published on the use of ultrasound (US) for facial nerve block in children and adults undergoing maxillofacial surgery. USG devices are becoming more accessible, more portable, cheaper, and more secure; And therefore, its introduction in the field of perioperative pain management of maxillofacial surgery still has a long way to go.
The maxillary nerve, like the ophthalmic nerve, is only sensory. It is detached from the anterolateral border of the trigeminal ganglion, laterally to the ophthalmic. From its origin, it heads anteriorly, traverses the foramen round, and penetrates the background of the infratemporal fossa until it enters the pterygopalatine fossa (except for the middle meningeal nerve, all its branches reach the pterygopalatine fossa before reaching the facies). In the pterygopalatine fossa, the maxillary nerve is located at the top of the cavity and passes superiorly to the maxillary artery and superolaterally to the pterygopalatine ganglion. The maxillary nerve receives and conducts through its endings the sensitivity of the skin of the cheek, lower eyelid, wing of the nose and upper lip. Its deep branches conduct the sensitivity of the mucosa of the lower part of the nasal cavities or respiratory area, of the tooth roots and of the gums of the maxilla.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
A 1:1 randomization table for patient allocation will be generated by a statistician who will not otherwise be involved in the study. Immediately upon the patient's arrival to the operating room, the research anesthesiologist will open a sealed, sequentially numbered opaque envelope containing the patient's assignment (block before surgery or block after surgery). Only anesthesiologists and operating room surgeons will not be blinded to patient assignment. This will be a double-blind study (patient and nurse). Patients will be unaware of the group they have been consecutively assigned to; and both the postoperative resuscitation nurses and the hospitalization ward nurses who will record visual analogue scale, analgesic consumption, onset of oral tolerance, postoperative nausea-vomiting and postoperative complications, will also be unaware of the analgesic treatment that the patient has received in the operating room.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing scheduled bimaxillary surgery
排除标准
- •refusal to participate in the study
- •patients scheduled for bimaxillary surgery together with another complementary surgical procedure (such as rhinoplasty, blepharoplasty)
- •age < 18 years
- •reinterventions
- •urgent surgeries
- •allergies to local anesthetics
- •allergies to anti-inflammatories
- •allergies to opioids
结局指标
主要结局
Inmediate Postoperative pain
时间窗: 2 hours postoperatively
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)
次要结局
- Pain at 8 hours postoperatively(8 hours postoperatively)
- Inmediate Use of Opioids(2 hours postoperatively)
- Pain 18 hours after surgery(18 hours postoperatively)
- Incidence of postoperative nausea and vomiting up to 18 hours postoperatively(18 hours postoperatively)
- Use of rescue opioids from 2 to 18 hours postoperatively(2 to 18 hours postoperatively)
- Incidence of immediate postoperative nausea and vomiting(2 hours postoperatively)
