Effect of Preoperative Ultrasound-guided Bilateral Maxillary Nerve Block Via the Pterygopalatine Fossa on Intraoperative Remifentanil Use in Septorhinoplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Intraoperative remifentanil consumption
研究概览
简要总结
Septorhinoplasty is generally a prolonged surgical procedure that frequently involves osteotomy, which may lead to increased intraoperative remifentanil requirements. Moreover, it is often associated with significant bleeding due to the dense capillary network of the nasal region, making the maintenance of low-to-normal blood pressure preferable during surgery. Consequently, achieving stable hemodynamics and providing sufficient analgesia throughout the procedure is essential.
This study aims to evaluate the effects of bilateral maxillary nerve block on intraoperative remifentanil consumption and postoperative analgesic efficacy in patients undergoing Septorhinoplasty. A total of 90 patients will be included in the study. Forty-five patients (Group M) will undergo Septorhinoplasty under general anesthesia combined with bilateral maxillary nerve block, while the remaining 45 patients (Group N) will receive general anesthesia alone.
In the preoperative phase, a bilateral maxillary nerve block will be performed under ultrasound guidance via the pterygopalatine fossa. During the intraoperative period, total remifentanil consumption will be recorded, alongside assessments of hemodynamic stability, sevoflurane consumption, extubation time, intraoperative bleeding volume, and the satisfaction levels of both the anesthesiologist and the surgeon.
In the postoperative period, patient satisfaction, pain scores at 0, 1, 2, 4, 6, 12, 18, and 24 hours as well as at 1 month (measured using the Visual Analog Scale - VAS), additional analgesic requirements, and Quality of Recovery-15 (QoR-15) scores (assessed on preoperative day 1, postoperative day 1, and at 1 month) will be evaluated.
详细描述
Septorhinoplasty is a surgical procedure that involves reshaping the nasal soft tissues, cartilage, and bone, and it frequently requires osteotomy. Manipulation of these structures typically results in moderate to severe postoperative pain. Nearly 30% of patients report pain scores of 6 or higher on the Numeric Rating Scale (NRS). Additionally, the use of nasal tampons in the postoperative period may exacerbate discomfort.
For postoperative pain management, nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids may be used. The American Society of Anesthesiologists (ASA) recommends the use of multimodal analgesia combined with regional anesthesia techniques during the perioperative period for the management of acute pain. The incorporation of regional techniques enhances analgesic efficacy synergistically and helps reduce opioid requirements, thereby lowering the incidence of related adverse effects. Moreover, regional techniques applied in the preoperative period are known to support more stable hemodynamic responses.
The trigeminal nerve provides the primary sensory innervation of the face. Its maxillary branch (V2) innervates the nasopharynx, palate, nasal cavity, maxillary sinus, skin of the nasal sidewall, and upper lip. After exiting the middle cranial fossa, it passes through the foramen rotundum and enters the pterygopalatine fossa, where it gives rise to several sensory branches. Among these, the infraorbital and nasopalatine nerves supply sensory innervation to the nasal septum mucosa. The posterior, superior, and inferior lateral nasal nerves, which also arise from the maxillary nerve, innervate the superior, middle, and inferior turbinates. Other branches supply sensation to the skin of the nasal ala and upper lip.
Although bilateral isolated infraorbital nerve block-a branch of the maxillary nerve-has been shown to provide analgesia following nasal surgeries, several studies have reported that analgesia may remain insufficient even with the addition of an infratrochlear nerve block. Therefore, rather than targeting individual branches, blockade of the maxillary nerve itself has been proposed. For this purpose, ultrasound-guided injection via the pterygopalatine fossa has been described.
The aim of this study is to compare intraoperative remifentanil consumption between patients who receive a preoperative bilateral maxillary nerve block and those who do not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those with an ASA (American Society of Anesthesiologists) score of I-II
- •Those with a body mass index (BMI) between 18 and 30
- •Those scheduled for elective surgery
- •Those who are fully cooperative Patients who meet the criteria for septorhinoplasty surgery
排除标准
- •Conditions that constitute a relative contraindication to regional anesthesia (e.g., coagulation disorders, thrombocytopenia, severe valvular heart disease, local infection at the injection site, allergy to local anesthetic agents)
- •International Normalized Ratio (INR) > 1.5
- •Facial paralysis or a history of facial paralysis
- •History of central nervous system vascular disease
- •Presence of neuropathy
- •History of surgery in the region where the block will be performed
- •American Society of Anesthesiologists (ASA) physical status classification of III or higher
- •Patients who do not want to participate in the study
- •Patients with chronic pain or chronic opioid use
- •Patients with alcohol, substance or drug addiction
- •Patients with limited cooperation such as dementia, psychiatric disorders
- •Pregnant and breastfeeding patients will be excluded from the study.
- •Patients who cannot communicate in their native language will be excluded from the study
结局指标
主要结局
Intraoperative remifentanil consumption
时间窗: İntraoperative-From induction of anesthesia to extubation (anesthesia duration)
Intraoperative remifentanil infusion will be initiated at 0.05 µg·kg-¹·min-¹. In accordance with the protocol, the rate will be titrated upward or downward based on arterial blood pressure, and the total intraoperative remifentanil dose will be recorded. The average remifentanil dose will be calculated by dividing the total dose by the total anesthesia time and the patient's body weight, and reported as µg·kg-¹·min-¹ and µg·kg-¹·h-¹
次要结局
- Intraoperative sevoflurane consumption(İntraoperative-İntraoperative-From induction of anesthesia to extubation (anesthesia duration))
- Extubation time(From the discontinuation of remifentanil and sevoflurane anesthesia until the time of tracheal extubation, assessed up to 30 minutes post-anesthesia discontinuation)
- The Quality of Recovery-15 (QoR-15) questionnaire(To be examined in the preoperative phase, at the 24th hour postoperatively and at the 1st month postoperatively)
- Postoperative pain(Postoperative day 1 (0-24 hours))
- Anesthesiologist, surgeon and patient satisfaction will be evaluated(Satisfaction ratings for the surgeon and anesthesiologist will be obtained immediately after surgery; the patient will be assessed at 24 hours postoperatively.)
- Postoperative bleeding index (Boezaart Bleeding Score)(İntraoperative ( during extubation))
研究者
Can Ozan Yazar
Principal İnvestigator
Ankara Etlik City Hospital