Effect of Intrathecal Morphine on Quality of Recovery of Patients Undergoing Laparoscopic Assisted Hysterectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To assess the impact of implementing ITM on QOR of patients undergoing laparoscopic-assisted hysterectomy between 18 to 70 years of age.
研究概览
简要总结
We hypothesize that patients receiving intrathecal morphine will have significantly improved quality of recovery, compared to those receiving standard analgesia following laparoscopic-assisted hysterectomy.
Aim of study To assess the impact of implementing ITM on QOR of patients undergoing laparoscopic-assisted hysterectomy between 18 to 70 years of age.
Primary objectiveQuality of recovery score on Postoperative Day 1.
Secondary objective****s
Quality of recovery score on POD 2 and To compare post-operative pain scores between both groups.
To compare post-operative analgesiaand IVopioid requirement in both groups.
To assess adverse effects related to the administration of intrathecal morphine
To assess the difference in length of hospital stay and overall patient satisfaction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients aged more than18 years up to 70 years ASA physical status I to ASAIII Patient scheduled for elective laparoscopic hysterectomy Ability to understand and complete the QoR-15 questionnaire.
排除标准
- •Declined consent to participate Contraindication to intrathecal morphine Morbid obesity BMI more than 35 kg per m2 History of chronic opioid use or opioid dependence Severe hepatic, renal, or respiratory disease Contraindications to neuraxial anesthesia.
结局指标
主要结局
To assess the impact of implementing ITM on QOR of patients undergoing laparoscopic-assisted hysterectomy between 18 to 70 years of age.
时间窗: pod 1
次要结局
- To compare post-operative analgesia/ IV-opioid requirement in both groups.
- To assess adverse effects related to the administration of intrathecal morphine
- To assess the difference in length of hospital stay and overall patient satisfaction
- Quality of recovery score on POD 2 and 3
- To compare post-operative pain scores between both groups.
研究者
BHAVYA PURI
PGIMER CHANDIGARH