Effect of Pre-extubation Bupivacaine Infiltration on Postoperative Pain and Opioid Consumption After Orthognathic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity
研究概览
简要总结
This study aims to evaluate whether injecting a long-acting local anesthetic (bupivacaine) at surgical sites before awakening from anesthesia can reduce pain and the need for opioid medications after orthognathic surgery. Orthognathic surgery is a major procedure that can cause significant postoperative pain, often requiring opioid analgesics, which may lead to side effects such as nausea, vomiting, and drowsiness. In this randomized clinical study, patients undergoing jaw surgery received either standard care or additional bupivacaine infiltration before extubation. Pain levels and opioid consumption were measured during the first 48 hours after surgery. We hypothesized that pre-extubation bupivacaine infiltration would improve pain control and reduce opioid requirements.
详细描述
Orthognathic surgery is commonly associated with moderate to severe postoperative pain, often requiring opioid-based analgesia. However, opioid use may be associated with adverse effects such as nausea, vomiting, sedation, and respiratory depression. Therefore, optimizing postoperative pain management while minimizing opioid consumption remains an important clinical goal.Local anesthetic infiltration has been proposed as a simple and effective method for improving postoperative analgesia. Bupivacaine, a long-acting local anesthetic, may provide prolonged pain control when administered at surgical sites.This randomized clinical study was conducted to evaluate the effect of pre-extubation infiltration of bupivacaine on postoperative pain and opioid consumption in patients undergoing orthognathic surgery. Patients undergoing one-piece Le Fort I osteotomy combined with bilateral sagittal split ramus osteotomy were randomly assigned to either a control group receiving standard care or a study group receiving additional infiltration of 0.5% bupivacaine with epinephrine at surgical sites prior to extubation.Postoperative pain was assessed using a visual analogue scale at predefined time points over a 48-hour period. Morphine consumption, including total and rescue doses, was recorded during the first 24 hours.It was hypothesized that pre-extubation bupivacaine infiltration would reduce postoperative pain intensity and opioid requirements compared with standard care
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
Participants, anesthesiologists, and outcome assessors were blinded to group allocation, whereas the surgeons performing the procedures were not blinded
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
- •American Society of Anesthesiologists (ASA) physical status I-II, age between 18 and 65 years, and planned one-piece Le Fort I osteotomy combined with bilateral sagittal split ramus osteotomy
排除标准
- •refusal to participate, ASA score ≥ III, congenital craniofacial anomalies, previous maxillofacial surgery, history of chronic opioid use, and allergy to local anesthetics or opioids.
研究组 & 干预措施
Bupivacaine group
Patients received standard perioperative care along with pre-extubation infiltration of 0.5% bupivacaine with epinephrine at the surgical sites
干预措施: Bupivacaine Infiltration (Drug)
Control group
Patients received standard perioperative care without pre-extubation bupivacaine infiltration.
干预措施: Standard medical treatment (Drug)
结局指标
主要结局
Postoperative Pain Intensity
时间窗: Up to 48 hours after surgery
Pain intensity assessed using the Visual Analog Scale (VAS), a 0-10 scale where 0 indicates no pain and 10 indicates worst possible pain, with higher scores indicating greater pain intensity, measured at 3, 6, 9, 12, 18, 24, 30, and 48 hours postoperatively.
Morphine Consumption
时间窗: Total and rescue morphine consumption recorded during the first 24 hours postoperatively.
Within the first 24 hours after surgery
次要结局
未报告次要终点
研究者
Esra Beyler
Assistant Professor
Baskent University
