Role of Topical Application of Lignocaine Versus 0.2% Glyceryl Trinitrate (GTN) Ointment as a Postoperative Local Analgesic in Hemorrhoidectomy in Terms of Pain Score,Wound Healing Time and Patient Satisfaction Level
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Postoperative pain score
研究概览
简要总结
This study is being conducted at the Department of General Surgery, King Edward Medical University, Lahore, Pakistan. The purpose of the trial is to compare the effectiveness of topical Lignocaine ointment versus topical Glyceryl Trinitrate (GTN) ointment in reducing postoperative pain following hemorrhoidectomy.
Patients undergoing hemorrhoidectomy will be randomly assigned to receive either Lignocaine ointment or GTN ointment applied locally after surgery. Pain relief will be assessed using a visual analog scale (VAS) at regular intervals during the postoperative period. The study aims to determine which ointment provides better pain control and improves patient comfort during recovery.
详细描述
This study aims to compare the effectiveness of lignocaine versus 0.2% glyceryl trinitrate (GTN) ointment as postoperative analgesics in patients who have undergone hemorrhoidectomy.
Background
Hemorrhoids are swollen veins in the anal region, commonly treated through Milligan-Morgan hemorrhoidectomy. Postoperative pain is a major concern, affecting mobility and delaying recovery.
Various treatments have been explored to alleviate post-hemorrhoidectomy pain, including anal dilatation, NSAIDs, opioids, and topical treatments like nifedipine, botulinum toxin, lignocaine, and GTN ointment.
Both GTN and lignocaine have been shown to reduce pain, but the most effective and safe option is still unclear.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 - 60 years
- •Both genders
- •Grade III and IV hemorrhoids diagnosed on the basis of history and clinical examination by consultant Surgeon.(Grade III Hemorrhoid manually reduced by patient with finger and Grade IV is prolapsed)
- •ASA (American society of Anesthesia) grades I, and II
排除标准
- •Previously reported allergy or reaction to lignocaine and GTN
- •Pregnancy or lactation
- •Concomitant perianal pathology warranting surgery
- •Cardiovascular disease
- •Patient taking Nitrates or Calcium channel blocker
研究组 & 干预措施
1.Lignocaine Ointment Group
Participants will receive topical lignocaine ointment applied to the anal wound post-hemorrhoidectomy for pain control.
干预措施: Lignocaine Ointment (Drug)
1.Lignocaine Ointment Group
Participants will receive topical lignocaine ointment applied to the anal wound post-hemorrhoidectomy for pain control.
干预措施: Glyceryl Trinitrate Ointment 0.2% (Drug)
Glyceryl Trinitrate Ointment Group
Participants will receive topical 0.2% glyceryl trinitrate ointment applied to the anal wound post-hemorrhoidectomy for pain control.
干预措施: Lignocaine Ointment (Drug)
Glyceryl Trinitrate Ointment Group
Participants will receive topical 0.2% glyceryl trinitrate ointment applied to the anal wound post-hemorrhoidectomy for pain control.
干预措施: Glyceryl Trinitrate Ointment 0.2% (Drug)
结局指标
主要结局
Postoperative pain score
时间窗: Up to 1 month postoperatively.
Pain intensity will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain severity.
Wound Healing Time
时间窗: Up to 1 month postoperatively.
Defined as the number of days from the date of surgery until complete wound healing (full epithelialization with no discharge or open area). Shorter duration indicates a better outcome.
次要结局
- patient Satisfaction Level(6 weeks postoperatively)
- Time to Request of First Analgesic Dose(Within 24 hours postoperatively)
- Amount of Analgesia Administered in First 24 Hours(0-24 hours postoperatively)
- Incidence of Wound Secretion(1 month postoperatively)
- Incidence of Itching(1 month postoperatively)
- Incidence of Postoperative Bleeding(1 month postoperatively)
- Incidence and Severity of Headache(1 month postoperatively)