The Efface of Ketamine vs. Lidocaine in the Management of Pain After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Postoperative Pain Score
研究概览
简要总结
This prospective interventional study conducted at Liaquat National Hospital and Medical College compared the analgesic efficacy of ketamine and lidocaine in managing postoperative pain after laparoscopic cholecystectomy. Total of 76 ASA I-II patients were randomly assigned into two equal groups (Group K: Ketamine, Group L: Lidocaine) using a sealed-envelope method in a double-blind, placebo-controlled design. Standard anesthesia with propofol, isoflurane, and atracurium was administered, and all patients received postoperative diclofenac sodium and ondansetron. Pain intensity was assessed using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours postoperatively. The study aimed to compare the pain-relieving effects of ketamine and lidocaine, contributing to improved strategies for postoperative pain management following laparoscopic cholecystectomy.
详细描述
Effective postoperative pain management is essential for promoting patient recovery, reducing stress response, and improving overall outcomes following laparoscopic cholecystectomy. This prospective interventional study was conducted at Department of Anesthesiology at Liaquat National Hospital and Medical College to compare the analgesic efficacy of intravenous ketamine and lidocaine in managing postoperative pain among patients undergoing elective laparoscopic cholecystectomy.
A total of 76 ASA grade I and II patients with uncomplicated symptomatic gallstone disease were enrolled after obtaining written informed consent and ethical approval. Using a sealed-envelope randomization method, patients were divided into two equal groups: Group K (n=38) received ketamine, and Group L (n=38) received lidocaine. The study followed a double-blinded, placebo-controlled design to ensure unbiased assessment. Patients with ASA grade III-V, chronic pain, psychiatric illness, pregnancy or lactation, major hepatic, renal, or cardiovascular dysfunction, or a recent history of opioid or NSAID use were excluded.
All participants underwent standard preoperative preparation, including overnight fasting and pre-anesthetic evaluation. General anesthesia was induced with propofol and atracurium and maintained with isoflurane. Standard intraoperative monitoring of pulse rate, blood pressure, ECG, SpO₂, and end-tidal CO₂ was performed. Following surgery, residual neuromuscular blockade was reversed with neostigmine. All patients received intravenous diclofenac sodium every 8 hours for baseline analgesia and ondansetron to prevent postoperative nausea and vomiting.
Pain intensity was assessed using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours postoperatively. Patients who reported pain received intravenous Kinz 5 mg as rescue analgesia, with timing recorded by nursing staff.
This study provided valuable insight into the comparative analgesic effects of ketamine and lidocaine for postoperative pain control following laparoscopic cholecystectomy, emphasizing their potential role in multimodal analgesia protocols to enhance patient comfort and recovery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-65 years.
- •ASA physical status I-II.
- •Elective laparoscopic cholecystectomy planned under general anesthesia.
- •Normal baseline renal, hepatic, and coagulation profile.
- •Able to give informed consent and communicate pain scores.
- •Negative pregnancy test for women of childbearing age.
排除标准
- •ASA III-V patients.
- •Allergy or hypersensitivity to ketamine, lidocaine, or related drugs.
- •History of psychiatric illness or substance abuse.
- •Chronic use of opioids, benzodiazepines, or MAO inhibitors.
- •Pregnant or breastfeeding women.
- •Chronic pain disorders or use of analgesics within 7 days pre-op.
- •Major hepatic, renal, or cardiovascular dysfunction.
- •History of myopathy or seizure disorders.
- •Patients with atrioventricular block or on calcium-channel blockers.
- •Conversion to open cholecystectomy during surgery.
- •Inability to understand or report pain postoperatively.
研究组 & 干预措施
Ketamine Group
The ketamine dose was calculated as 0.5 mg/kg of body weight, diluted with normal saline to a total volume of 10 mL, and administered intravenously as a stat dose during anesthesia reversal, following the completion of surgery.
干预措施: IV ketamine 0.5 mg/kg (Drug)
Lidocaine Group
A total of 3 mL of 2% lidocaine was diluted with 7 mL of normal saline to prepare a 10 mL solution, which was administered intravenously as a stat dose at the time of anesthesia reversal, immediately after completion of surgery.
干预措施: IV Lidocain 60 mg/kg (Drug)
结局指标
主要结局
Postoperative Pain Score
时间窗: Postoperative pain was assessed at the 1st, 6th, 12th, and 24th hours.
Postoperative pain intensity was assessed using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours after surgery to evaluate and compare the effectiveness and duration of analgesia between the ketamine and lidocaine groups. These time intervals were selected to monitor both the early and late postoperative pain responses during the first 24 hours of recovery.
次要结局
未报告次要终点
研究者
Mustafa Hussain Imam
Mustafa Hussain Imam
Liaquat National Hospital & Medical College