Comparative Study of Intraperitoneal Instillation of Ropivacaine with Two Different Doses of Dexmedetomidine for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To evaluate the duration of analgesia following intraperitoneal
研究概览
简要总结
This study is a prospective randomized double blind parallel group active controlled trial conducted in patients undergoing elective laparoscopic cholecystectomy. The aim is to compare the efficacy of intraperitoneal ropivacaine combined with two different doses of dexmedetomidine for postoperative analgesia. Patients will be randomly assigned to receive ropivacaine with dexmedetomidine 0.5 microgram per kilogram or ropivacaine with dexmedetomidine 1 microgram per kilogram. The primary outcome is the duration of analgesia measured as time to first rescue analgesic requirement. Secondary outcomes include total analgesic consumption in the first 24 hours, incidence of shoulder pain, sedation scores, and postoperative bowel movements. This study is expected to identify the optimal and safe dose of dexmedetomidine for intraperitoneal use in order to improve postoperative pain relief and reduce opioid related adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 to 65 years undergoing elective laparoscopic cholecystectomy ASA physical status I,II.
排除标准
- •ASA physical status III or IV.
- •Patients with contraindications to ropivacaine or dexmedetomidine.
- •Patients with chronic pain conditions or on chronic opioid therapy.
- •Patients who are unwilling to participate in the study.
结局指标
主要结局
To evaluate the duration of analgesia following intraperitoneal
时间窗: Continuous monitoring until first rescue analgesic — records exact time (hours and minutes) from end of surgery to first rescue dose. | Pain scores (NPRS) to detect the need for rescue will be recorded at: 0 h (on arrival to PACU), 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 12 h, 18 h and 24 h. | If no rescue analgesic is required within 24 h, duration is censored at 24 h.
administration of ropivacaine with two different doses of
时间窗: Continuous monitoring until first rescue analgesic — records exact time (hours and minutes) from end of surgery to first rescue dose. | Pain scores (NPRS) to detect the need for rescue will be recorded at: 0 h (on arrival to PACU), 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 12 h, 18 h and 24 h. | If no rescue analgesic is required within 24 h, duration is censored at 24 h.
dexmedetomidine.
时间窗: Continuous monitoring until first rescue analgesic — records exact time (hours and minutes) from end of surgery to first rescue dose. | Pain scores (NPRS) to detect the need for rescue will be recorded at: 0 h (on arrival to PACU), 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 12 h, 18 h and 24 h. | If no rescue analgesic is required within 24 h, duration is censored at 24 h.
次要结局
- To evaluate the total analgesic consumption in the first 24 hours(postoperatively.)
研究者
Maneesh V S
Naruvi Hospitals