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Clinical Trials/CTRI/2025/12/098707
CTRI/2025/12/098707Not yet recruitingNot Applicable

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

SWETHA A1 site in 1 country62 target enrollmentStarted: December 20, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
62
Locations
1
Primary Endpoint
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.

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • undergoing elective laparoscopic abdominoperineal excision surgeries.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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.

Time Frame: 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.

Secondary Outcomes

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

Investigators

Sponsor
SWETHA A
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

SWETHA A

CHRISTIAN MEDICAL COLLEGE, VELLORE

Study Sites (1)

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