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临床试验/NCT07345039
NCT07345039招募中不适用

Comparison of Infraorbital-Infratrochlear Nerve Block and Transnasal Sphenopalatine Ganglion Block on Postoperative Analgesia and Recovery Outcomes in Septorhinoplasty: A Prospective, Randomized, Double-Blind Clinical Trial

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital0 个研究点目标入组 86 人开始时间: 2026年1月16日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
86
主要终点
Postoperative Pain Intensity

研究概览

简要总结

This prospective, randomized, double-blind clinical trial aims to compare the postoperative analgesic efficacy and recovery outcomes of infraorbital-infratrochlear nerve block and transnasal sphenopalatine ganglion block in patients undergoing septorhinoplasty under general anesthesia. Adult patients aged 18-65 years with ASA I-II status will be randomized to receive either bilateral infraorbital-infratrochlear block or transnasal sphenopalatine ganglion block after induction of anesthesia. Postoperative outcomes including pain scores (NRS at 0-2 h, 2-8 h, and 8-24 h), emergence agitation, Riker Sedation-Agitation Scale (RSAS) scores, time to first rescue analgesic, total tramadol consumption, adverse events, surgical site complications, and patient satisfaction will be assessed and compared between groups.

详细描述

This study is designed to evaluate the postoperative analgesic efficacy and clinical outcomes of two regional anesthesia techniques-infraorbital-infratrochlear nerve block (ION-ITN block) and transnasal sphenopalatine ganglion block (usg guided sphenopalatine ganglion block,SPG block)-in patients undergoing septorhinoplasty under general anesthesia. Eligible patients aged 18-65 years with ASA physical status I-II will be randomly assigned to one of two intervention groups. Blocks will be performed after induction by an anesthesiologist not involved in postoperative assessment. Patients, surgeons, anesthesiologists performing postoperative evaluations, follow-up investigators, and data analysts will remain blinded to group allocation.

Postoperative outcomes will include pain intensity assessed using the Numerical Rating Scale (NRS) at 0-2, 2-8, and 8-24 hours after surgery, agitation between extubation and PACU discharge assessed with the Riker Sedation-Agitation Scale (RSAS), emergence agitation (RSAS ≥5), time to first rescue analgesic, and total tramadol consumption within 24 hours. Additional outcomes include postoperative nausea and vomiting, cardiovascular and respiratory adverse events, surgical site complications (edema, hematoma, neurologic deficit), and patient satisfaction measured by a 5-point Likert scale. Preoperative demographics, BMI, ASA class, comorbidities, anesthesia and surgery duration, and intraoperative remifentanil consumption will be recorded. The study aims to determine whether SPG block provides superior postoperative analgesia compared with ION-ITN block in septorhinoplasty patients.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Patients, surgeons, anesthesiologists assessing postoperative outcomes, follow-up investigators, and data analysts were all blinded to group allocation throughout the perioperative period.

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

入选标准

  • age 18-65 years.
  • Scheduled for septorhinoplasty under general anesthesia.
  • American Society of Anesthesiologists (ASA) Physical Status I-II.
  • Ability to cooperate with postoperative evaluations.
  • Provision of written informed consent.

排除标准

  • Allergy or contraindication to local anesthetics used in the study.
  • Coagulopathy or anticoagulant therapy.
  • Local infection at the nerve block application sites.
  • Severe nasal anatomical abnormalities preventing transnasal block application.
  • Psychiatric disorders affecting pain or agitation assessment..
  • Chronic pain conditions or chronic opioid use.
  • Neurological disorders affecting sensory perception.
  • Refusal to participate.

研究组 & 干预措施

Infraorbital-Infratrochlear Nerve Block (ION-ITN Block)

Active Comparator

Infraorbital-Infratrochlear Nerve Block (ION-ITN Block)

干预措施: Infraorbital-Infratrochlear Nerve Block (Procedure)

Sphenopalatine Ganglion Block

Active Comparator

Transnasal Sphenopalatine Ganglion Block (SPG Block)

干预措施: Transnasal Sphenopalatine Ganglion Block (Procedure)

结局指标

主要结局

Postoperative Pain Intensity

时间窗: 0-24 hours postoperative

Pain intensity assessed using the Numerical Rating Scale (NRS, 0-10) at three postoperative intervals: 0-2 hours, 2-8 hours, and 8-24 hours. Higher scores indicate greater pain.

Postoperative Agitation

时间窗: Immediate postoperative period (from extubation to discharge from the post-anesthesia care unit [PACU]; up to 2 hours)

Agitation severity assessed using the Riker Sedation-Agitation Scale (RSAS). The highest postoperative RSAS score is recorded. RSAS ≥5 is defined as emergence agitation.

次要结局

  • Total Tramadol Consumption(First 24 hours postoperative)
  • Incidence of Postoperative Nausea and Vomiting (PONV)(0-24 hours postoperative)
  • Adverse Events in PACU(Immediate postoperative period (from extubation to discharge from the post-anesthesia care unit [PACU]; up to 2 hours))
  • Patient Satisfaction Score(At 24 hours postoperative)

研究者

发起方
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Acil,MD

Principal Investigator

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

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