跳至主要内容
临床试验/CTRI/2025/12/098707
CTRI/2025/12/098707尚未招募不适用

Evaluation Of Efficacy Of Bilateral Pudendal Nerve Block As Postoperative Analgesia In Laparoscopic Abdominoperineal Excision Surgeries- A Prospective Observational Study

SWETHA A1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2025年12月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
62
试验地点
1
主要终点
Assessment of postoperative pain intensity at intervals of 6, 12, 24 and 48 hours using Visual Analog Scale (VAS: 0–10) at rest and on movement.

研究概览

简要总结

Laparoscopic Abdominoperineal excision (APE) remains a key surgical option for low rectal cancers and certain anal malignancies where sphincter preservation is not feasible, particularly for tumours involving the anal sphincter complex. Even with advanced sphincter preserving approaches, laparoscopic APE is sometimes indispensable, especially for ensuring adequate oncologic margins. Postoperative pain, especially from the perineal wound, is a common and significant problem after APE. Standard analgesic strategies for APE such as intravenous opioids and epidural analgesia may be only partially effective for perineal pain and are associated with adverse effects like urinary retention, sedation, and delayed bowel function.

In this context, bilateral pudendal nerve block (PNB) has emerged as a valuable adjunct to conventional analgesia, directly targeting the sensory supply of the perineal region. The pudendal nerve arises from sacral roots S2,S3,S4 and innervates most perineal structures. Bilateral pudendal nerve block performed by anatomical landmark, nerve stimulator, or ultrasound guidance, has been shown in systematic reviews and randomized studies to significantly reduce pain intensity and opioid requirements after perineal surgery, including APE.

The use of PNB is associated with high efficacy, relatively favourable safety profile, and low incidence of complications. Incorporating bilateral PNB into multimodal analgesic protocols for laparoscopic APE thus enhances postoperative pain control, promotes earlier mobilization, reduces opioid-related side effects, and improves patient satisfaction and recovery.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • undergoing elective laparoscopic abdominoperineal excision surgeries.

排除标准

  • Patient refusal 1.Patients with allergic history for local anesthetic drug
  • Patients with coagulopathies
  • Patients with active infection at injection site 4.Emergency surgeries
  • Conversion to open laparotomy.

结局指标

主要结局

Assessment of postoperative pain intensity at intervals of 6, 12, 24 and 48 hours using Visual Analog Scale (VAS: 0–10) at rest and on movement.

时间窗: Assessment of postoperative pain intensity at intervals of 6, 12, 24 and 48 hours using Visual Analog Scale (VAS: 0–10) at rest and on movement.

次要结局

  • 1.Time for rescue analgesia.(2.Perineal pain score.)

研究者

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

SWETHA A

CHRISTIAN MEDICAL COLLEGE, VELLORE

研究点 (1)

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