NCT00510666已完成4 期
Butorphanol and Tramadol for Morphine PCA Pain Management After Total Hysterectomy
Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 841 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 841
- 试验地点
- 1
- 主要终点
- VAS pain scoring;
研究概览
简要总结
Intravenous patient-controlled analgesia (PCA) is a popular technique for postoperative pain management. Although several drugs are recognized as effective therapeutic options, optimal selection of drugs in hysterectomy patients underwent different anesthesia treatments remains unknown explicitly. The investigators hypothesized that butorphanol and tramadol can produce different analgesic effects with intravenous PCA after abdominal hysterectomy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-II
- •Uterus myoma
排除标准
- •Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records.
- •Participants younger than 18yr，older than 65yr or pregnancy was eliminated.
- •Due to the significant changes in vital signs might affect cognition of pain and that of sensation, over 20% variation of these records from the baselines or below 92% of SpO2 under 20-40% nasal tube oxygen at any time should be excluded from the study.
- •Those who were not willing to or could not finish the whole study at any time.
- •Any patient who exhibited a combative or incoherent state of PCA analgesia would be excluded from the study.
- •Allergy to local anesthetics.
- •Failed to perform the epidural catheterization.
- •Those who demonstrated significant nerve-associated side effects from the insertion of the epidural needle.
研究组 & 干预措施
1
Experimental
Butorphanol basal infusion adjunct to morphine PCA
干预措施: Butorphanol tartrate (Drug)
2
Experimental
Saline infusion adjunct to morphine PCA
干预措施: Saline (Drug)
3
Experimental
Premedication of Tramadol
干预措施: Tramadol Hydrochloride (Drug)
4
Experimental
Preemptive saline for morphine PCA
干预措施: Saline (Drug)
结局指标
主要结局
VAS pain scoring;
时间窗: 5 months
次要结局
- VAS sedation scoring; VAS happiness scoring; Adverse effects; Patient's overall conditions.(5 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Comparing Post-Operative Analgesic Effects of PCAM With Dexmedetomidine 1 mcg/ml vs PCAM With Dexmedetomidine 2 mcg/mlPost-Operative AnalgesiaOpioid Use, UnspecifiedLaparotomy SurgeryNCT05288738Universiti Kebangsaan Malaysia Medical Centre68
已完成
不适用
Tailored PCA Based on Preoperative Pain SensitivityAnalgesia, Patient-ControlledNCT03252977Seoul National University Hospital118
已完成
4 期
Bupivacaine Liposomal Injection (Exparel) for Postsurgical Analgesia in Patient Undergoing Laparoscopic Bariatric SurgeryPain, PostoperativeNCT02969187The Cleveland Clinic126
Unknown
不适用
Comparison of Analgesic Efficacy and Occurrence of Emesis Among Different Background Infusion and Bolus Administration Regimens of Fentanyl Based Intravenous Patient-controlled Analgesia in Patients After Laparoscopic Assisted Gastrectomy - a Randomized Blind Study -The Patients With Gastric Cancer Who Are Scheduled to Receive Laparoscopy Assisted GastrectomyNCT01863355Yonsei University225
已完成
不适用
NSAIDs With Morphine-PCA Compared to Epidural Analgesia in Thoracotomy PainPostoperative PainNCT01541137Helsinki University Central Hospital30