Phase I Randomized, Single-blind, Placebo-controlled, Single-center Study of the Effect of Postoperative Administration of Single Dose Ketamine on Pain and Recovery After Robotic Removal of Endometriosis in Patients With Chronic Pelvic Pain
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Pelvic Pain Score on Visual Analogue Scale (VAS)
研究概览
简要总结
This is a randomized, single blinded, placebo-controlled trial to study the effectiveness of a subanesthetic dose (0.6 mg/kg) of ketamine versus placebo (saline) on postoperative pain and pain on adult female chronic pelvic pain patients undergoing robotic removal of endometriosis. The objective of the study is to explore the effect of a sub anesthetic dose of ketamine (0.6 mg/kg) vs. saline control on postoperative pain and recovery in chronic pelvic pain patients who have undergone robotic removal of endometriosis.
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
- Single (Participant)
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
- •Adults, aged 18 to 65 years old
- •Experiencing chronic pain, defined as experiencing moderate to severe pelvic pain for greater than 6 months
- •Scheduled to undergo robotic endometriosis removal surgery
- •Willing to comply with all study procedures and be available for the duration of the study.
- •Subject is medically stable.
排除标准
- •Cognitive impairment (by history) or clinical signs of altered mental status such as confusion, amnesia, disorientation, fluctuating levels of alertness, etc. that may interference with adherence to study procedures and/or participant safety.
- •Past ketamine or phencyclidine misuse or abuse
- •Schizophrenia or history of psychosis
- •Known sensitivity or allergy to ketamine
- •Liver or renal insufficiency.
- •History of uncontrolled hypertension, chest pain, cardiac arrythmia, stroke, head trauma, intracranial mass or hemorrhage or pressure, glaucoma, acute globe injury, uncontrolled thyroid disease, porphyria, or any other contraindication to ketamine. Use of lamotrigine, alfentanil, physostigmine, and 4-aminopyridine are contraindicated
- •Pregnancy or nursing women
- •Currently participating in another pain interventional trial
- •Unwillingness to give informed consent
- •Non-English-speaking patients as the EHP-30 instrument has only been licensed to NYULH in English.
研究组 & 干预措施
Low-Dose Ketamine (LDK) Treatment Group
干预措施: Ketamine (Drug)
Control Group
干预措施: Placebo (Drug)
结局指标
主要结局
Pelvic Pain Score on Visual Analogue Scale (VAS)
时间窗: Post-Operative Day (POD) 83
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
次要结局
- Score on General Anxiety Disorder-7 Screener (GAD-7)(Post-Operative Day (POD) 83)
- Score on Montgomery-Åsberg Depression Rating Scale (MADRS)(Post-Operative Day (POD) 83)
- Change in Opioid Use(Baseline, Post-Operative Day (POD) 83)
- Score on Endometriosis Health Profile-30 (EHP-30) Questionnaire(Post-Operative Day (POD) 83)