The Role of Ketamine and Magnesium in Post-operative Pain Control After Laparoscopic Surgery in Patients With Chronic Pelvic Pain Treated With Opioids: A Double-Blinded Randomized Control Trial.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Post-operative pain score using the Numeric Rating Scale (NRS)
研究概览
简要总结
The goal of this research proposal is to determine if the intraoperative administrative of Ketamine and Magnesium during laparoscopic gynecologic surgery improves postoperative pain in patients on chronic opioid therapy for management of chronic pelvic pain.
详细描述
In this randomized control trial, patients' postoperative pain scores will be assessed as scored by the Numeric Rating Score (NRS) system. Intraoperative and postoperative narcotic usage, nausea scores and patients' perception of their quality of recovery via the QoR-40 survey will also be assessed.
The use of intraoperative Ketamine and Magnesium is predicted to decrease postoperative pain in patients on chronic opioid therapy for management of chronic pelvic pain and will overall improve patients' postoperative experience.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects undergoing elective laparoscopic gynecologic surgery
- •Patients with chronic pelvic pain defined as pain that has persisted for more than 6 months in duration which is localized to the pelvis, anterior abdominal wall, lower back or buttocks and has leads to functional disability or medical care1
- •Patients requiring opioids daily for >1 month
- •Consenting adults age 18-80
- •American Society of Anesthesiologists (ASA) Physical Status classification II to ASA III
排除标准
- •Patient refusal
- •Chronic Kidney disease (Creatinine>2)
- •Patients treated with methadone
- •Known allergy or adverse effect of ketamine or magnesium
- •Patient unable to give informed consent
- •Patient with limited or no English fluency
- •Uncontrolled hypertension
研究组 & 干预措施
Ketamine plus Magnesium sulfate
Ketamine 0.5mg/kg IV dose with 2g magnesium IV dose
干预措施: Ketamine plus Magnesium sulfate (Drug)
Placebo
Normal Saline (NaCl 0.9%)
干预措施: Placebo (Drug)
结局指标
主要结局
Post-operative pain score using the Numeric Rating Scale (NRS)
时间窗: 1st 24 hours post-op
Patient described pain level on a scale of 0-10
次要结局
- Post-operative opioid use(24 hours post operative)
- Recovery Questionnaire(3-5 days post operative)
- Nausea Scores using PONV Impact Scale Score(24 hours Post operative)
- Intraoperative fentanyl use(Intraoperative)
- Length of Hospital Stay(24 hours Post operative)
研究者
Stacey Duryea
Physician
Milton S. Hershey Medical Center