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临床试验/CTRI/2024/12/078514
CTRI/2024/12/078514尚未招募2 期

Analgesic effectiveness of pudendal nerve block for postoperative pain management in anorectal surgery- randomized controlled study

Marnanjal Kumar1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年1月20日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
• To compare the postoperative pain with the help of Visual analogue score at 0,3,6,12 and 24 hrs

研究概览

简要总结

Anorectal surgeries often result in significant postoperative pain, which can impede recovery and necessitate high doses of opioid analgesics, leading to adverse effects. Effective pain management strategies are crucial to enhance patient comfort, expedite recovery, and reduce opioid consumption. Pudendal nerve block (PNB) targets the primary nerve supplying the anorectal region, potentially offering superior pain control. Despite its theoretical advantages, there is limited clinical evidence on its efficacy and safety in this context.  This study to evaluates the efficacy of pudendal nerve block (PNB) in managing postoperative pain following anorectal surgery. The research involved patients undergoing various anorectal procedures, who were randomly assigned to receive either a pudendal nerve block or a placebo. Aim of this study to assess the effectiveness of pudendal nerve block in post operative pain relief for anorectal surgeries. Primary Objective -To assess the Postoperative pain with the help of Visual analogue score at 0,3,6,12 and 24hrs. Secondary  Objectives: Requirement of rescue analgesic(total dose) and Total length of hospital stay.

Randomization will be done computer generated random number table all Patient will be divided in two groups.  Group A : Saddle block + Pudendal nerve block – 0.25% levobupivacaine 10ml/each side. Group B : (Control group) Saddle block – 0.5% bupivacaine heavy 1.5 ml.

Key findings indicated that patients who received the PNB reported significantly lower pain scores compared to the placebo group, particularly in the first 24 hours after surgery. Additionally, the PNB group required fewer opioid analgesics, demonstrating an overall reduction in postoperative opioid consumption. Secondary outcomes, including patient satisfaction and the requirement of rescue analgesic (total dose) and total length of hospital stay.

The study concludes that pudendal nerve block is a valuable technique in the multimodal approach to postoperative pain management for anorectal surgeries, offering better pain relief and reducing the need for opioid medications.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patient of either sex of age group 18-60 years ,ASA I,II and III posted for elective haemorrhoidectomy surgery under saddle block.

排除标准

  • Perianal suppurative lesions Malignancy Inflammatory bowel disease ASA III & ASA IV Contraindicated to regional Anesthesia.

结局指标

主要结局

• To compare the postoperative pain with the help of Visual analogue score at 0,3,6,12 and 24 hrs

时间窗: 0,3,6,12 and 24 hrs

次要结局

  • To compare Requirement of total rescue analgesic and Total length of hospital stay

研究者

发起方
Marnanjal Kumar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

MARNANJAL KUMAR

King Georges Medical University

研究点 (1)

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