Effect of Ultrasound Guided Pecs Block With Intravenous Ketamine and Ketamine Infusion Alone For Prevention of Chronic Post-Surgical Pain in Patients Undergoing Breast Cancer Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Frequency of Chronic Post-operative Pain
研究概览
简要总结
The goal of this clinical trial is to is to compare the effectiveness of ultrasound-guided Pecs block with intravenous ketamine versus intravenous ketamine infusion alone in preventing Chronic Post-Surgical Pain (CPSP) in patients undergoing breast cancer surgery. The main question it aims to answer is,
How effective is the ketamine and ketamine with pecs block in reducing the frequency of Chronic Post-Surgical Pain after breast cancer 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult female patients with breast cancer aged between 18-75 years
- •ASA (American Society of Anesthesia) physical status I, II, and III
- •Patients scheduled for elective breast cancer surgery (Mastectomy with or without axillary clearance)
排除标准
- •Refusal to participate or withdrawal of informed consent
- •Surgical procedures involving breast reconstruction with flaps or implants
- •Patient scheduled for bilateral mastectomy
- •Reoperation on the same side due to cancer recurrence
- •Known allergy or contraindication to study drugs
- •History of severe psychiatric illness (e.g., major depression, bipolar disorder, schizophrenia)
- •Chronic opioid use, substance abuse, or opioid addiction
- •Pre-existing chronic pain or neuropathic pain disorders
- •Coagulopathy, anticoagulation therapy, or localized infection at the site of block
- •Uncontrolled hypertension and ischemic heart disease
研究组 & 干预措施
Group K
Intravenous Nalbuphine 0.1 mg/kg Paracetamol 1g or 15mg/kg (if weight is < 50kg).
Additionally, before skin incision, a bolus 0.35 mg/kg ketamine will be given followed by a continuous infusion 0.25 mg/kg/hr (11) will be administered. Ketamine infusion will be stopped 30 minutes before the end of the surgery.
干预措施: Ketamine (Drug)
Group K
Intravenous Nalbuphine 0.1 mg/kg Paracetamol 1g or 15mg/kg (if weight is < 50kg).
Additionally, before skin incision, a bolus 0.35 mg/kg ketamine will be given followed by a continuous infusion 0.25 mg/kg/hr (11) will be administered. Ketamine infusion will be stopped 30 minutes before the end of the surgery.
干预措施: Nalbuphine (Drug)
Group K
Intravenous Nalbuphine 0.1 mg/kg Paracetamol 1g or 15mg/kg (if weight is < 50kg).
Additionally, before skin incision, a bolus 0.35 mg/kg ketamine will be given followed by a continuous infusion 0.25 mg/kg/hr (11) will be administered. Ketamine infusion will be stopped 30 minutes before the end of the surgery.
干预措施: Paracetamol (Drug)
Group K+ Pecs
Intravenous Nalbuphine 0.1 mg/kg Paracetamol 1g or 15mg/kg (if weight is < 50kg).
Additionally, before skin incision, a bolus 0.35 mg/kg ketamine will be given followed by a continuous infusion 0.25 mg/kg/hr (11) will be administered. Ketamine infusion will be stopped 30 minutes before the end of the surgery.
Additionally, Pecs block will be performed before surgical incision with the help of an ultrasound (US) by experienced anesthesiologist. The drug used for the pecs block will be two syringes of 10ml and 20 ml containing bupivacaine 0.25% (total 30 ml).
干预措施: Ketamine (Drug)
Group K+ Pecs
Intravenous Nalbuphine 0.1 mg/kg Paracetamol 1g or 15mg/kg (if weight is < 50kg).
Additionally, before skin incision, a bolus 0.35 mg/kg ketamine will be given followed by a continuous infusion 0.25 mg/kg/hr (11) will be administered. Ketamine infusion will be stopped 30 minutes before the end of the surgery.
Additionally, Pecs block will be performed before surgical incision with the help of an ultrasound (US) by experienced anesthesiologist. The drug used for the pecs block will be two syringes of 10ml and 20 ml containing bupivacaine 0.25% (total 30 ml).
干预措施: Pecs block (Procedure)
Group K+ Pecs
Intravenous Nalbuphine 0.1 mg/kg Paracetamol 1g or 15mg/kg (if weight is < 50kg).
Additionally, before skin incision, a bolus 0.35 mg/kg ketamine will be given followed by a continuous infusion 0.25 mg/kg/hr (11) will be administered. Ketamine infusion will be stopped 30 minutes before the end of the surgery.
Additionally, Pecs block will be performed before surgical incision with the help of an ultrasound (US) by experienced anesthesiologist. The drug used for the pecs block will be two syringes of 10ml and 20 ml containing bupivacaine 0.25% (total 30 ml).
干预措施: Nalbuphine (Drug)
Group K+ Pecs
Intravenous Nalbuphine 0.1 mg/kg Paracetamol 1g or 15mg/kg (if weight is < 50kg).
Additionally, before skin incision, a bolus 0.35 mg/kg ketamine will be given followed by a continuous infusion 0.25 mg/kg/hr (11) will be administered. Ketamine infusion will be stopped 30 minutes before the end of the surgery.
Additionally, Pecs block will be performed before surgical incision with the help of an ultrasound (US) by experienced anesthesiologist. The drug used for the pecs block will be two syringes of 10ml and 20 ml containing bupivacaine 0.25% (total 30 ml).
干预措施: Paracetamol (Drug)
Group C
Intravenous Nalbuphine 0.1 mg/kg Paracetamol 1g or 15mg/kg (if weight is < 50kg).
干预措施: Nalbuphine (Drug)
Group C
Intravenous Nalbuphine 0.1 mg/kg Paracetamol 1g or 15mg/kg (if weight is < 50kg).
干预措施: Paracetamol (Drug)
结局指标
主要结局
Frequency of Chronic Post-operative Pain
时间窗: Data will be collected from patients in the breast clinic or via telephone at one week, 1,2, 3, and 6 months after surgery.
Pain intensity will be assessed using an 11-point numeric rating scale (NRS) by an investigator blinded to group allocation. Scores range from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain severity and therefore a worse outcome. Data will be collected from patients in the breast clinic or via telephone at one week, 1,2, 3, and 6 months after surgery. All patients will be followed till six months after discharge from the hospital.
次要结局
- Character of Chronic Post-Surgical Pain(Till six months after discharge from the hospital.)
- Duration of Chronic Post-Surgical Pain(Till six months after discharge from the hospital.)
- Distribution of Chronic Post-Surgical Pain(Till six months after discharge from the hospital.)
研究者
Ali Sarfraz Siddiqui
Assistant professor
Aga Khan University