NCT04831736已完成4 期
Randomized, Single-blind, Placebo-controlled Study on the Effect of Postoperative Administration of Single Dose Ketamine After Mastectomy on Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score
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 (0.6mg/kg) of ketamine versus placebo (saline) on postoperative pain on adult women undergoing mastectomy.
The objective of the study is to examine the effect of a subanesthetic dose (0.6mg/kg) of ketamine vs. saline control on postoperative pain in subjects who have undergone mastectomy.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women, aged 18 to 80 years old, who will undergo mastectomy.
- •Willing to comply with all study procedures and be available for the duration of the study.
- •Will be scheduled for elective breast surgery for oncologic indication as follows: mastectomy +/- lymph node dissection, prophylactic mastectomy, unilateral or bilateral, with immediate reconstruction
- •No distant metastases.
- •Subject is American Society of Anesthesiologists (ASA) physical status 1, 2, or
- •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 QoR-15 and BCPQ have not been validated in all other languages
研究组 & 干预措施
Treatment
Experimental
干预措施: Ketamine (Drug)
Control
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score
时间窗: 48 Hours Post-Op (Day 3)
BPI Pain Severity Subscale consists of 4 questions (asking to rate pain). Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain.
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score(Day 7 Post-Op (Day 8))
- Generalized Anxiety Disorder (GAD-2) Score(Day 7 Post-Op (Day 8))
- Quality of Recovery (QoR-15) Survey Score(Day 7 Post-Op (Day 8))
- Number of Participants Who Experience Side Effects(Day 1 Post-Op (Day 2))
- Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score(Day 7 Post-Op (Day 8))
- Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score(Day 7 Post-Op (Day 8))
- Total Dosage of Opioid Use(Day 7 Post-Op (Day 8))
- Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score(Day 7 Post-Op (Day 8))
- Breast Cancer Pain Questionnaire (BCPQ) - Pain Score(Day 7 Post-Op (Day 8))
研究者
研究点 (1)
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