Effectiveness of Low-Dose Ketamine and Intravenous Lidocaine Versus Fentanyl for Postoperative Pain for Patients Undergoing Elective Gynecologic Surgery Under General Anesthesia: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The numerical rating scale will measure the postoperative pain severity
研究概览
简要总结
Background: Rational approaches to perioperative patient management have been used to meet intraoperative analgesic needs and avoid opioid-related adverse effects. A combination of drugs, such as ketamine, sodium channel blockers, anti-inflammatories, and alpha-2 agonists, can be used. This study aimed to compare the effectiveness of low-dose ketamine and intravenous lidocaine with fentanyl for intraoperative pain in patients undergoing gynecologic surgery.
Objective: To determine the effectiveness of low-dose ketamine and intravenous lidocaine versus fentanyl for postoperative pain in patients undergoing elective gynecologic surgery under general anesthesia at Dilla University General and Teaching Hospital from April 10, 2023, to June 10, 2023.
Methodology: A randomized, controlled, single-blind trial will be conducted with 68 adult patients undergoing elective gynecologic surgery under GA. Eligible patients undergoing gynecologic surgery in both study areas will be allocated by a computer-generated random allocation sequence in equal ratios to the treatment group (T) receiving low-dose ketamine and IV lidocaine and the control group (C) receiving fentanyl. The primary outcome variable is the postoperative pain score measured at PACU, 6 hours, 12 hours, and 24 hours postoperatively. Secondary outcomes are analgesic consumption, postoperative hypoxemia, Quality of immediate postoperative recovery assessed by the quality of recovery (QoR-40) questionnaire on postoperative days 1, and postoperative nausea and vomiting. It will be collected up to 24 hours postoperatively. Data will be analyzed using Student's t-test, analysis of variance, chi-square test, and Mann-Whitney test. Parametric and non-parametric categorical data will be analyzed using the chi-squared test and Fisher's exact test, respectively. Statistical significance will be a p-value of 0.05.
Work plan and budgeting: - study will be conducted from April 10, 2023, to June 10, 2023, with a cost of 41625 ETB.
详细描述
After obtaining ethical clearance from Dilla University College of Health Sciences and Medicine's ethics review board, a structured questionnaire will be developed and translated into the respective languages by the principal investigator (PI). Two BSC anesthetists involved in patient management will be selected at the study area and trained in the overall process of participant handling and data collection.
During the preoperative period Patients undergoing gynecologic operations during the study period will be assessed and informed about the study process and anesthesia on the day before surgery. The patient will receive maintenance fluid, have bilateral peripheral IV lines secured, and will be NPO the night before surgery. On the morning of the procedure, both a standard informed consent form for the procedure and a separate consent form for the study were available.
The availability and functionality of the bilateral IV line and NPO status will be checked, and prophylactic drugs will be given. Standard preoperative questionnaires were used, and data were collected through patient responses and medical records, such as patient monitoring and charts.
During the intraoperative period Routine ASA monitoring will be checked and applied for patients in both groups when they present to the OR. The functionality and availability of the bilateral IV line and urinary catheter were rechecked. Propofol (3 mg/kg) was used to induce anesthesia after the patient had been pre-oxygenated for both groups. An intravenous bolus of 0.5 mg/kg of ketamine during the induction phase for patients in the treatment group, then a continuous infusion of 0.2 mg/kg/hr. 0f ketamine. A bolus of 1.5 mg/kg was given before induction, and the same dose of lidocaine was administered every 15 to 20 minutes after induction of anesthesia until the start of skin closure.
Patients in the control group were induced with fentanyl 2 μg/kg given during induction of anesthesia with propofol 3mg/kg. 0.5 μg /kg of fentanyl was given every 20-30 minutes up to the start of skin closure.
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
- Single (Participant)
盲法说明
Only participants will not be allowed to now the group they allocated. The anesthetist involved in patient management will prepare drugs. Apart from patient management, the anaesthetist will not be involved in any other study processes. Participants will be given the study group code and allowed to present it to OR. Participants assigned to groups will not know which group they have been selected for.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •ASA I and II patients between the ages of 18 and 65 undergoing elective gynecologic surgery under general anaesthesia
排除标准
- •Patients with allergies to any of the drugs used in the trial Patients with chronic pain Patients who are diagnosed with CNS diseases like psychiatric diseases, epilepsy Patients who are hypertensive and taking beta blockers, as well as those who have preoperative bradycardia, hypotension, or any type of heart block, Breastfeeding and pregnant women Patients weighing less than 40 kg or obese patients (BMI > 35 kg/m2) Patients with a history of smoking
研究组 & 干预措施
An Experimental or treatment group (T)
The Experimental or treatment group (T) will receive ketamine 0.5 mg/kg bolus, then 0.2 mg/kg infusion, and IV lidocaine 1.5 kg/kg bolus. The same bolus dose of lidocaine will be repeated every 15 to 20 minutes.
干预措施: Low dose intravenous ketamine (Drug)
Control group (C)
The control group (C) will receive a conventional general anesthesia (GA) with fentanyl 2µg/kg given during induction of anesthesia and one fourth of initial dose of fentanyl will be given over 20-30 minutes.
干预措施: Low dose intravenous ketamine (Drug)
结局指标
主要结局
The numerical rating scale will measure the postoperative pain severity
时间窗: From the patient's arrival at PACU to 24 hours postoperatively (at PACU, at 6 hours, 12 hours, and 24 hours).
Will be assessed by the validated numerical rating scale, a reliable tool for assessing pain intensity in all populations, regardless of literacy level which employs a 0-to-10 ratings. scale, with 0 representing no pain and 10 representing the worst possible pain. The English and Amharic versions of the scale are attached in
次要结局
- The occurrence of postoperative nausea and vomiting (PONV)(At arrival at PACU to 24hours (at PACU, at 6 hours, 12 hours, and 24 hours))
研究者
Amanuel Asefa Akirso
Effectiveness of Low-Dose Ketamine and Intravenous Lidocaine Versus Fentanyl for Postoperative Pain for Patients Undergoing Elective Gynecologic Surgery
Dilla University