The Effect of Opioid-Free Anesthesia in TMJ Surgery: A Prospective Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain Score
研究概览
简要总结
This study aims is to evaluate the effect of opioid free total intravenous anesthesia on postoperative quality of recovery in patients undergoing oral and maxillofacial surgery (OMF) temporomandibular joint (TMJ) surgery.
详细描述
This study will enroll 60 patients undergoing TMJ surgery at Massachusetts General Hospital. Anesthetic care will be standardized according to current institutional standards of care. Intraoperative clinicians will not be blinded to group assignment. Patients will be randomized to one of two groups:
- Group 1 - Opioid-free Anesthesia Patients: Patients who are not receiving opioids but the total intravenous anesthetic during surgery.
- Group 2 - Standard Anesthesia Patients: Patients who undergo the standard of care and receive opioids as part of their anesthetic regimen.
Both groups employ strategies that are routinely used as part of standard clinical practice for TMJ surgery. Patients will otherwise receive the institutional standards of care for their surgical procedure and perioperative care.
Following intraoperative drug administration patients will be followed until discharge from the PACU to assess study endpoints while in the hospital. At the time of discharge from the PACU, members of the study team will ask the patient to compete a brief survey on their satisfaction with pain management.
Patients in this study will be anticipated to be discharged the same day as the surgical procedure. At the time of hospital or PACU discharge, the patient will be provided with a Medication Diary. This will be used to record pain medication administration in the first 48 hours after surgery, as well as any pain or complication they might experience at home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 75 (inclusive)
- •Scheduled for TMJ surgery (including both unilateral and bilateral procedures)
- •Planned arthroscopic surgical procedure
- •Preoperative plan to discharge the same day
排除标准
- •Inability to provide written informed consent
- •Pregnant patients
- •Open TMJ Surgeries
- •Planned overnight admission
- •Mental status disorder or patient who are unable to communicate
研究组 & 干预措施
Opioid-free Anesthesia
Patients in this arm will not receiving opioids but the total intravenous anesthetic during surgery. Patients in this group will receive an infusion of lidocaine, ketamine, or dexmedetomidine supplemented with other intravenous analgesics and intravenous and inhaled anesthetics.
干预措施: Dexmedetomidine / Ketamine / Lidocaine (Drug)
结局指标
主要结局
Pain Score
时间窗: Through in-hospital study completion, an average of 1 day
Pain will be measured using the eleven point (0 to 10) numeric rating scale with higher values representing a worse outcome. Pain scores will be recorded every 15 minutes until discharge from the post-anesthesia care unit (PACU) and at 12 and 24 hours postoperatively. Clinically documented pain scores will be recorded. Our primary outcome will be the worst documented pain score while in the PACU. Additional pain score time points will be evaluated as secondary endpoints.
次要结局
- Perioperative Opioid Use(48 hours postoperatively)
- Rescue Analgesia in the PACU(Through in-hospital study completion, an average of 1 day)
- Pain Satisfaction(Completed upon the patient reaching PACU Phase I in the hospital, up to approximately 6 hours)
- Incidence of Opioid Related Adverse Effects(48 hours postoperatively)
- Length of Stay (PACU Discharge)(Through in-hospital study completion, an average of 1 day)
- Percocet Use(48 hours postoperatively)
- Length of Stay (Hospital Discharge)(Through in-hospital study completion, an average of 1 day)
研究者
Jingping Wang, MD, Ph.D.
Associate Professor
Massachusetts General Hospital