Comparison of Intrathecal Dexmedetomidine Versus Intrathecal Fentanyl as Adjuvants to Bupivacaine on Post-Operative Urinary Retention in Lower Limb Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Incidence of Postoperative Urinary Retention (POUR) at the 3rd Postoperative Hour
研究概览
简要总结
This study aims to compare two medications, dexmedetomidine and fentanyl, when used alongside a commonly used spinal anesthetic called bupivacaine in patients undergoing lower limb surgery. The main focus of the study is to see which combination causes fewer problems with urination after surgery - a condition known as postoperative urinary retention (POUR). POUR can lead to discomfort, delayed recovery, and a need for catheterization. Dexmedetomidine is a newer drug that may help reduce this problem compared to fentanyl, which is more commonly used but may increase the risk of urinary retention. This trial will help determine which medication combination provides better pain relief while reducing urinary side effects. The study is being conducted as a randomized, double-blind trial at a hospital in Nepal and will include 190 adult patients.
详细描述
Spinal anaesthesia is a common and effective method used to manage pain during lower limb surgeries. It allows patients to remain awake and comfortable while providing excellent pain control. To make spinal anaesthesia last longer and provide better pain relief, certain medications called adjuvants are added to the main anaesthetic drug, bupivacaine. Two commonly used adjuvants are fentanyl, an opioid, and dexmedetomidine, a medication that works on the body's alpha-2 receptors to provide sedation and pain relief.
However, a known side effect of spinal anaesthesia especially when combined with certain adjuvants is postoperative urinary retention (POUR). This condition occurs when a patient is unable to urinate normally after surgery. POUR can be uncomfortable, may delay recovery, and often requires insertion of a urinary catheter, which can increase the risk of infection and hospital stay.
This clinical trial, called the D-FAB POUR Trial, is designed to find out which of these two adjuvants dexmedetomidine or fentanyl is more likely to cause or prevent POUR when used with bupivacaine in patients undergoing elective lower limb surgery.
The study will involve 190 adult patients. Each participant will receive spinal anaesthesia with bupivacaine and be randomly assigned to also receive either dexmedetomidine or fentanyl. Neither the patients nor the doctors will know which medication is given in a process known as double-blinding to ensure fairness and eliminate bias.
The researchers will monitor the ability of patients to urinate at the third and sixth hours after surgery, using ultrasound to measure bladder volume. If the patient is unable to pass urine and the bladder is overly full, temporary or longer-term catheterisation may be needed. These outcomes will help determine how each drug affects bladder function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
In this double-blind study, both the participants and the care providers (anesthesiologists) will be blinded to group allocation. The study drugs will be prepared in identical syringes by an independent assistant who is not involved in patient care or outcome assessment. Outcome assessors responsible for measuring postoperative urinary retention and other clinical parameters will also be masked. However, the data analyst will not be blinded to group assignments during statistical analysis, as unblinded data will be required for appropriate group comparisons.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 60 years
- •Scheduled for elective lower limb surgery under spinal anesthesia
- •Classified as American Society of Anesthesiologists (ASA) physical status II or III
- •Minimum height of 150 cm (to ensure uniform drug volume)
- •Able to understand the study procedures and provide written informed consent (in English or Nepali)
排除标准
- •Contraindications to spinal anesthesia (e.g., coagulopathy, infection at injection site, hemodynamic instability)
- •Known allergy or hypersensitivity to bupivacaine, fentanyl, or dexmedetomidine
- •Chronic pain conditions or long-term opioid use
- •Neurological, Cardiac, Renal, or uncontrolled diabetic conditions
- •Current treatment for prostatic pathology or use of alpha-2 blockers
- •Presence of a Foley's catheter preoperatively
- •Estimated surgical duration: >2.5 hours
- •Inability or unwillingness to provide informed consent
结局指标
主要结局
Incidence of Postoperative Urinary Retention (POUR) at the 3rd Postoperative Hour
时间窗: 3 hours after spinal anesthesia
The primary outcome is the number of participants who are unable to void urine at the 3rd postoperative hour with a urinary bladder (UB) volume of ≥600 mL, confirmed by bladder ultrasound. Participants meeting this criterion will be considered to have postoperative urinary retention and will undergo in-out catheterization.
次要结局
- Requirement of Urinary Catheterization at 6th Postoperative Hour(6 hours after spinal anesthesia)
研究者
Sujan Dhakal, MD
Principal Investigator
Tribhuvan University Teaching Hospital, Institute Of Medicine.