Comparison of the Efficacy of Opioid-Free Anaesthesia and Opioid-Based Anaesthesia in Gynecological Laparoscopic Sterilization Under ERAS Protocol : A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Postoperative Pain Control and Recovery Outcomes
研究概览
简要总结
The study aims to compare the efficacy of opioid-free anesthesia (OFA) versus opioid-based anesthesia (OA) in gynecological laparoscopic sterilization surgeries within the framework of Enhanced Recovery After Surgery (ERAS) protocols. With India’s high demand for efficient and safe surgical options, particularly in family planning methods, exploring optimized perioperative strategies is imperative.
Gynecological laparoscopic surgeries have gained popularity due to their minimally invasive nature and associated benefits such as reduced postoperative pain and shorter hospital stays. The adoption of ERAS protocols further enhances recovery outcomes by emphasizing multidisciplinary approaches to patient care.
OFA represents a promising alternative to traditional opioid-based anesthesia, offering improved safety profiles and effective analgesia. However, its efficacy within ERAS protocols, particularly in gynecological laparoscopic surgery, requires further investigation.
Several studies have examined OFA’s impact on perioperative outcomes, indicating comparable efficacy to OA in terms of pain control and recovery parameters. However, concerns regarding prolonged recovery times and sedation levels necessitate additional research.
The proposed study will be a prospective, randomized, double-blinded controlled trial conducted at Dr. Radhakrishnan Medical College, focusing on postoperative pain control, recovery outcomes, and patient satisfaction. The primary objective is to determine if OFA is non-inferior to OA in terms of pain control, satisfaction, and recovery time. Secondary objectives include assessing postoperative pain scores, hemodynamic stability, patient satisfaction, and quality of recovery using the QoR-15 questionnaire.
The study will enroll 62 female participants aged 25 to 45 years scheduled for elective gynecological laparoscopic sterilization surgeries. Anesthesia techniques, data collection, and statistical analysis will adhere to established protocols. Ethical considerations and patient safety will be paramount throughout the study.
By evaluating the comparative efficacy of OFA and OA within ERAS protocols, the study aims to refine anesthesia approaches and improve patient outcomes in gynecological laparoscopic surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Scheduled for elective gynecological laparoscopic sterilisation.
- •2.Able to provide informed consent.
- •3.ASA grade I or II.
- •4.Hemodynamically stable with no acute medical illness requiring urgent intervention.
- •5.Not pregnant or breastfeeding.
- •6.No known allergies to study medications.
- •7.Willing to comply with study procedures and follow-up assessments.
排除标准
- •1.Emergency surgeries or surgeries requiring conversion to open procedures.
- •2.ASA physical status above II.
- •3.History of significant cardiac, hepatic, renal, or respiratory disease.
- •4.Known allergy or contraindication to study medications.
- •5.Chronic opioid use or dependence.
- •6.Pregnancy or breastfeeding 7.Inability to provide informed consent.
- •8.Any condition deemed by the investigator to pose a risk to the patient or interfere with the study procedures.
- •9.Duration of surgery more than 30 min.
结局指标
主要结局
Postoperative Pain Control and Recovery Outcomes
时间窗: Preoperative (baseline assessment) | Intraoperative (during surgery) | Postoperative: | a. Immediate postoperative period (e.g., recovery room) | b. 24 hours postoperative
次要结局
- 1. Postoperative pain scores and analgesic requirements in first 24 hours post-surgery(2. Intraoperative hemodynamic stability during surgery)
研究者
DrIkshit Singh
Dr.Radhakrishnan Government Medical College