Postoperative quality of recovery after hysterectomy in patient on Duloxetine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- 1. Quality of Recovery-40
研究概览
简要总结
Postoperative pain is one of the main issues in postoperative care and plays an important role
in accelerating the improvement of surgical patient’s general condition 1 . Female patients have
worse quality of recovery after surgery than male patients. The greater propensity for pain
and opioid-related side effects are likely contributing factors for poor postsurgical recovery in
women. Hysterectomy is a commonly performed surgical procedure in women, and it often
results in significant pain and slow recovery 2 . One of the strategies to prevent chronic
postoperative pain is to reduce the acute pain in the initial phase using effective medications
with the least side effects. Nevertheless, pharmacologic strategies to improve global quality
of recovery after hysterectomy have yet to be examined 2 .
In this study, we intended to evaluate the effect of perioperative administration of oral
Duloxetine on postoperative pain and recovery in patients undergoing hysterectomy.
Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) commonly
used to treat depression, anxiety and chronic pain. The medication works by increasing the
levels of serotonin and norepinephrine in the brain, which can help to reduce pain, improve
mood and promote relaxation. Duloxetine has also been found to have a mild analgesic effect
and has been investigated as a premedication for various surgical procedures, including
hysterectomy. Duloxetine premedication in hysterectomy effectively reduces pain and
improves patient satisfaction. Duloxetine has been shown to improve the quality of
anaesthesia, reduce the need for additional pain medication and cause lesser adverse events
when compared to those who do not receive premedication.
This study aims to investigate the efficacy and safety of perioperative oral Duloxetine on
quality of recovery and as an analgesia in adult patients undergoing hysterectomy and the
Quality of Recovery-40 questionnaire (QoR-40) shall be used for evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients with benign gynaecologic conditions (fibroids, pelvic pain, uterine prolapse) who are planned to undergo hysterectomy under spinal anaesthesia.
- •Female patients older than 18 years with ASA I or II.
排除标准
- •Patients with chronic non-gynaecologic conditions (liver or pulmonary disease, diabetes mellitus)
- •The history of use of psychotropic drugs (anti-depressants, neuroleptics, lithium) in the last 1 year.
- •Those with Duloxetine allergy.
- •Patients using opioids for gynaecologic or non-gynaecologic conditions.
结局指标
主要结局
1. Quality of Recovery-40
时间窗: Both the respective Groups will be assessed Postoperatively at 6th, 12th and 24th hours after the surgery.
questionnaire total score
时间窗: Both the respective Groups will be assessed Postoperatively at 6th, 12th and 24th hours after the surgery.
2. Visual Analogue score
时间窗: Both the respective Groups will be assessed Postoperatively at 6th, 12th and 24th hours after the surgery.
次要结局
- 1. Opioid analgesic consumption(doses (Fentanyl))
研究者
Dr Kashmla Khan
Kasturba Medical College, Mangalore