NCT05700045已完成不适用
Effect of Dexmedetomidine Combined With Ropivacaine Transverse Abdominal Plane Block (TAP) on Opioid Dosage After Cesarean Section Under Multimodal Analgesia
Xijing Hospital2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年5月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Consumption of hydromorphone
研究概览
简要总结
To evaluate the effect of dexmedetomidine as an adjuvant of ropivacaine in the TAP block on cesarean section parturients under multimodal analgesia, optimize the multimodal analgesia program for cesarean section, and guide perioperative analgesia managemen。This is a single center, double-blind, randomized clinical trial.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •37-42 weeks of gestation
- •Plan cesarean section
- •Receiving patient controlled intravenous analgesia
- •Age>18 years
- •ASA（American Society of Anesthesiologists) grade I-III
- •Voluntary participation and informed consent
排除标准
- •The anesthesia method for cesarean section is general anesthesia or intraspinal anesthesia, and epidural administration is used
- •Combined with other opioids during operation
- •High risk pregnancy (multiple pregnancy, in vitro pregnancy, etc.) or pregnancy related complications (hypertension, preeclampsia, chorioamnionitis, etc.)
- •Times of previous cesarean section ≥ 3
- •BMI ≥ 50kg/m2 is not suitable for TAP block
- •Allergies or contraindications to the drugs involved in the study
- •Combined with operations other than tubal ligation and ovariectomy
- •Severe renal function impairment (SCR>176 µ mol/L and/or blood urea nitrogen>17.9 mmol/L), severe liver function impairment (ALT and/or aspartate aminotransferase exceed 3 times the upper limit of normal value)
- •Increased risk of coagulation dysfunction or bleeding (PLT<80 × 109/L or international normalized ratio> 1.5)
- •History of chronic pain or opiate abuse
- •Other clinical trials in the last three months
研究组 & 干预措施
dexmedetomidine + ropivacaine
Experimental
each side dexmedetomidine 0.5ug/kg+0.25% ropivacaine 20ml TAP block
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Consumption of hydromorphone
时间窗: 48 hours after surgery
Consumption of hydromorphone 48 hours after surgery
次要结局
- Postoperative Ramsay score(48 hours after surgery)
- Consumption of hydromorphone(24 hours after surgery)
- Numeric Rating Scale(48 hours after surgery)
- Postoperative satisfaction(48 hours after surgery)
- First time to press bolus(48 hours after surgery)
- Attempts of pressing bolus(48 hours after surgery)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety Study of Dexmedetomidine as an Additive to Local Anesthetics in Shoulder SurgeryDrug SafetySelf EfficacyNCT01557270Prof. Peter Gerner, M.D.62
已完成
不适用
A Comparative Study of the Effect of Epidural Dexmedetomidine Versus Fentanyl Added to Ropivacaine in Pediatric Orthopedic SurgeryCongenital Skelectal AnomalyNCT02375191Yonsei University58
已完成
4 期
A clinical trial to study the effect of addition of dexmedetomidine with local anesthesia on pain relief after arm and hand surgeryCTRI/2013/12/004209Director60
尚未招募
4 期
To compare whether Dexmedetomidine added to Ropivacaine or Ropivacaine alone in Transverse Abdominis Plane block in patients undergoing Laparoscopic cholecystectomy will be better in alleviating haemodynamic response and provide post operative analgesiaCTRI/2024/01/061166Rajendra Institute of Medical Sciences
已完成
1 期
Dexmedetomidine in Transversus Abdominis Plane Block for Laparoscopic CholecystectomyElective Laparoscopic CholecystectomyNCT02031510Imam Abdulrahman Bin Faisal University195