A Randomized Comparative Study of Pudendal Nerve Block With Bupivacaine Alone and Bupivacaine With Methylene Blue for Postoperative Analgesia in Perianal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Time to the first rescue analgesic administration (in minutes) in the two study groups
研究概览
简要总结
Study Description:
The goal of this clinical trial is to compare the duration of postoperative pain relief achieved with two different approaches to pudendal nerve block in patients undergoing elective perianal surgery. The main question this study aims to answer is whether adding Methylene Blue to Bupivacaine pudendal nerve block can prolong postoperative analgesia compared to using Bupivacaine alone.
Participants in this study will be individuals with ASA I and II physical status undergoing elective perianal surgery under spinal anesthesia. They will be randomly assigned to one of two groups:
- Group A (Case Group): Participants will receive a pudendal nerve block with Bupivacaine combined with Methylene Blue.
- Group B (Control Group): Participants will receive a pudendal nerve block with Bupivacaine alone.
The pudendal nerve block will be performed using ultrasound guidance at the level of the ischial spine. The needle tip will be positioned between the Sacro tuberous and sacrospinous ligaments to inject the local anesthetic or the local anesthetic combined with Methylene Blue.
Throughout the study, the researchers will monitor the time to the first rescue analgesic, assess pain levels using the Numeric Rating Scale at various time intervals (2, 6, 24, 48 hours, and 7 days), and observe for any side effects or complications related to the intervention.
Participants will be closely observed after surgery to assess their pain levels and analgesic requirements. The researchers will also evaluate patient satisfaction using the Likert scale.
By comparing the outcomes between the two groups, the study aims to determine if the addition of Methylene Blue to Bupivacaine pudendal nerve block provides superior postoperative analgesia in perianal surgery patients. This information will contribute to the understanding of effective pain management strategies for individuals undergoing perianal surgical procedures and potentially reduce the need for opioids and improve patient outcomes.
详细描述
Study Description:
The aim of this randomized comparative study is to investigate the effectiveness of two different approaches to postoperative analgesia in patients undergoing perianal surgery. The study will compare the use of Bupivacaine alone with Bupivacaine combined with Methylene Blue in a pudendal nerve block.
Perianal surgical procedures, such as abscess drainage, fistulectomy, and hemorrhoidectomy, can cause significant postoperative pain. The goal of this study is to find a more effective and prolonged method of pain relief to improve patient comfort and reduce the need for opioids.
Participants in this study will be individuals scheduled for elective perianal surgery and classified as ASA I and II. They will be randomly assigned to one of two groups:
- Group A: Participants will receive a pudendal nerve block with Bupivacaine and Methylene Blue.
- Group B: Participants will receive a pudendal nerve block with Bupivacaine alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients of ASA I and II undergoing elective perianal surgery under spinal anesthesia
排除标准
- •Patient's refusal
- •Patient with a history of allergy to the local anesthetic or Methylene blue
- •Bleeding diathesis or coagulopathy
- •Extensive infection at the site of injection
- •Pregnancy and lactating mother
- •Spinal abnormality
- •Patients with neurological deficit
结局指标
主要结局
Time to the first rescue analgesic administration (in minutes) in the two study groups
时间窗: 48 hours
We will compare the time at which patients in either group will demand rescue analgesic
Patient satisfaction assessed using the Likert scale after receiving Bupivacaine pudendal nerve block with or without Methylene Blue.
时间窗: Seven days
We will ask the patient to select one of the following satisfaction scores: Very satisfied Moderately satisfied Neither satisfied nor dissatisfied Moderately dissatisfied Very dissatisfied
次要结局
- Complications(seven days)
- Numeric Rating Scale (NRS) score for pain intensity at different time intervals(Seven days)
研究者
Saurav Raj Khatiwada
Resident Doctor
Nepal Mediciti Hospital