Intraperitoneal Atomization of Levobupivacaine During Gynaecological Laparoscopic Procedures ; Impact on Pain, Opioid Use and Length of Recovery Room Stay (IPLA).
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Post-operative pain intensity after laparoscopic gynaecological surgery in 1-day hospital setting.
研究概览
简要总结
In this study, we will compare 3 treatments. The first group of patients will receive the standard treatment (paracetamol, diclofenac and an opioid if necessary) with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine) . The second group of patients will receive the standard of care, with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine) and additional injection of the local anesthetic ( 0.5% levobupivacaine, non -diluted) in the peritoneal cavity via a trocar both at the beginning and the end of the surgery . The third group of patients will receive the standard of care, with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine) and additional intraperitoneal atomization of the local anesthetic. We will use non-diluted 0.5% levobupivacaine delivered directly onto the target sites both at the beginning and the end of surgery. The drug will be delivered using OptiSpray® surgical spray device, an inexpensive delivery system that will direct a fine mist of drug directly to the areas of the peritoneal cavity that are theoretically the cause of post-op pain (diaphragms, peritoneal abdominal surface, surgical dissection site).
Our primary goal is to assess the efficacy of intraperitoneal atomization of levobupivacaine in reducing postoperative pain and of opioid requirements in patients undergoing gynecological laparoscopic procedures in one-day surgery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who are planned for gynaecological laparoscopic interventions on an ambulatory basis.
排除标准
- •Less than 18 year old.
- •Weight less than 50 kg and more than 80 kg.
- •Pregnant.
- •Prisoners;
- •Allergic to topical anesthetics (Amides specifically).
- •Allergic to Opioids as a class.
- •Currently or within the last 30 days been prescribed an opiate medication.
- •Chronic pain syndrome.
研究组 & 干预措施
Infiltration of portal sites with 0,5% levobupivacaine.
The first group of patients will receive the standard treatment (paracetamol, diclofenac and an opioid if necessary) with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine).
干预措施: Standard Injection of Levobupivacaine in portal sites. (Drug)
Additional injection of 0.5% levobupivacaine via a trocar
The second group of patients will receive the standard of care, with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine) and additional injection of the local anesthetic ( 0.5% levobupivacaine, non -diluted) in the peritoneal cavity via a trocar both at the beginning and the end of the surgery.
干预措施: Standard Injection of Levobupivacaine in portal sites. (Drug)
Additional injection of 0.5% levobupivacaine via a trocar
The second group of patients will receive the standard of care, with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine) and additional injection of the local anesthetic ( 0.5% levobupivacaine, non -diluted) in the peritoneal cavity via a trocar both at the beginning and the end of the surgery.
干预措施: Additional injection of 0,5% levobupivacaine. (Drug)
Additional intraperitoneal atomization of levobupivacaine.
The third group of patients will receive the standard of care, with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine) and additional intraperitoneal atomization of the local anesthetic.
干预措施: Standard Injection of Levobupivacaine in portal sites. (Drug)
Additional intraperitoneal atomization of levobupivacaine.
The third group of patients will receive the standard of care, with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine) and additional intraperitoneal atomization of the local anesthetic.
干预措施: Intraperitoneal atomization of levobupivacaine. (Drug)
结局指标
主要结局
Post-operative pain intensity after laparoscopic gynaecological surgery in 1-day hospital setting.
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 1 day.
Pain evaluation will be done using an 11-point numeric rating scale (0 = no pain, 10 = worst pain possible).
Post-operative shoulder pain after laparoscopic gynecological procedure in 1-day hospital setting.
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 1 day.
Pain evaluation will be done using an 11-point numeric rating scale (0 = no pain, 10 = worst pain possible).
次要结局
- Post-operative opioid analgesic requirements after laparoscopic gynaecological surgery.(Participants will be followed for the duration of hospital stay, an expected average of 1 day.)
- Post-operative shoulder pain after laparoscopic gynecological surgery from hospital discharge until 24 hrs post-operatively.(Patients will be followed until 24 hours post-operatively.)
- Time until discharge from hospital.(Patients will be followed until an estimated 24 hours post-operatively.)
- Time until discharge from recovery room.(Up until discharge from recovery room post-operatively, probably a few hours.)
- Post-operative pain intensity after laparoscopic gynaecological surgery from hospital discharge until 24 hrs post-operatively.(Patients will be followed until 24 hours post-operatively.)
- Post-operative nausea and vomiting (PONV) in the first 24 hrs post-operatively, after laparoscopic gynecological surgery.(Patients will be followed until 24 hours post-operatively.)
- Post-operative sedation until hospital discharge, after laparoscopic gynecological surgery.(Patients will be followed up to 6 hrs post-operatively.)