Patient-Controlled Analgesia (PCA) With Ketamine-Morphine (PCA KetaMorph) vs PCA Morphine for Postoperative Analgesia in Idiopathic Scoliosis Surgery - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Cumulative Morphine Consumption
研究概览
简要总结
The goal of this clinical trial is to evaluate whether adding low-dose ketamine to PCA morphine reduces opioid requirements after posterior spinal fusion surgery in adolescent idiopathic scoliosis patients. Selected patients aged 10-18 years undergoing elective AIS surgery at University Malaya Medical Centre will be randomised to ketamine-morphine or morphine-only PCA. The primary outcome is cumulative morphine consumption at 48 hours, with secondary outcomes including pain scores, opioid-related adverse effects, time to ambulation, and patient satisfaction. This study aligns with national priorities for safe opioid stewardship and enhanced peri-operative care in Malaysia.
详细描述
Posterior spinal fusion (PSF) is the definitive surgical treatment for patients with scoliosis. However, the procedure involves extensive tissue dissection, resulting in significant postoperative pain. Although patient-controlled analgesia (PCA) with intravenous morphine remains the current standard, the large doses required are frequently associated with side effects such as nausea, vomiting, pruritus, and sedation [4-6]. These complications delay mobilisation, prolong hospital stay, increase healthcare costs, and may contribute to opioid tolerance, undermining effective pain control.
Enhanced Recovery After Surgery (ERAS) protocols strongly promote multimodal analgesia, which combines opioid and non-opioid agents to achieve synergistic pain relief while minimising opioid exposure. This strategy has been shown to reduce side effects, improve recovery, shorten hospital stay, and lower the risk of opioid-related tolerance, hyperalgesia, and potential long-term dependence. Despite these advantages, evidence for the use of ketamine-morphine PCA in scoliosis surgery remains limited, and subanaesthetic ketamine-though effective intraoperatively as an opioid-sparing agent-remains underutilised in postoperative PCA regimens. Our previous study demonstrated that co-administration of subanaesthetic ketamine (0.5 mg/kg) at induction reduced postoperative pain sensitivity and hyperalgesia typically associated with high-dose remifentanil infusion, a strong opioid analgesic [13]. This finding underscores the potential role of ketamine as an opioid-sparing adjunct.
Building on this, we propose a single-centre, double-blind, randomised controlled trial in 114 idiopathic scoliosis patients undergoing elective PSF at University Malaya Medical Centre. Participants will be randomised to receive PCA containing ketamine-morphine (1 mg/mL + 1 mg/mL) or morphine (1 mg/mL) alone, with identical syringes to ensure allocation concealment. The primary endpoint is cumulative morphine consumption at 48 hours, while secondary outcomes include pain scores, opioid-related side effects, time to ambulation, and patient satisfaction.
This study aims to provide the first Malaysian evidence on an opioid-sparing PCA regimen, addressing national ERAS priorities and contributing to global opioid stewardship.
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged > 10 years old
- •Idiopathic scoliosis scheduled for single-stage posterior spinal fusion (PSF).
- •American Society of Anaesthesiologists (ASA) physical status I-II.
排除标准
- •Known hypersensitivity to morphine, ketamine or formulation excipients.
- •Hepatic dysfunction (ALT or AST > 2 × upper limit of normal).
- •Renal impairment (eGFR ≤ 60 mL min-¹ 1·73 m-²).
- •Uncontrolled asthma or severe restrictive lung disease.
- •Cardiac disease or clinically significant arrhythmia.
- •Intellectual disability precluding PCA use.
- •Chronic opioid therapy or pre-operative pain > 3 months.
- •Concomitant monoamine-oxidase inhibitor or tricyclic antidepressant therapy.
- •History of severe postoperative delirium.
研究组 & 干预措施
Ketamine-Morphine PCA (1:1 ratio)
This group receives a ketamine-morphine PCA solution (1 mg mL-¹ + 1 mg mL-¹). This device deliver a 1 mL bolus, enforce a five-minute lock-out and cap delivery at 20 mL per four hours, with no background infusion. The patient will use PCA for at least 48 hours duration.
干预措施: Ketamine-Morphine PCA (Combination Product)
Morphine only PCA
This group receives morphine alone PCA (1 mg mL-¹). This device deliver a 1 mL bolus, enforce a five-minute lock-out and cap delivery at 20 mL per four hours, with no background infusion. The patient will use PCA for at least 48 hours duration.
干预措施: Morphine (Intravenous patient-controlled analgesia) (Drug)
结局指标
主要结局
Cumulative Morphine Consumption
时间窗: From end of surgery (Hour 0) to 48 hours post-operation (Day 2).
Total amount of intravenous morphine (in milligrams) administered via the Patient-Controlled Analgesia (PCA) device. This includes both the demand doses and any clinician-administered boluses.
次要结局
- Post-operative Pain Intensity(At 6, 12, 18, 24, 30, 36, 42, and 48 hours post-operatively.)
- Incidence of Opioid-Related Adverse Events (ORAEs)(From the end of surgery through 48 hours post-operatively.)
- Duration of Hospital Stay(From date of surgery until hospital discharge (approximately 3-7 days).)
- Time to First Post-operative Flatus(Up to 48 hours post-operatively.)
- Time to First Ambulation(Up to 48 hours post-operatively.)
- Patient Satisfaction With Pain Management(At the time of hospital discharge (approximately Day 3 to Day 7 post-operatively).)
研究者
MUHAMMAD FAEEZ BIN MOHD YUSOH
Postgraduate Medical Officer
University of Malaya