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CTRI Number  CTRI/2025/12/098707 [Registered on: 09/12/2025] Trial Registered Prospectively
Last Modified On: 08/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study to assess the postoperative pain score after pudendal nerve block in patients undergoing laparoscopic abdominoperineal excision surgery for anorectal carcinoma. 
Scientific Title of Study   Evaluation Of Efficacy Of Bilateral Pudendal Nerve Block As Postoperative Analgesia In Laparoscopic Abdominoperineal Excision Surgeries- A Prospective Observational Study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SWETHA A 
Designation  POST GRADUATE RESIDENT 
Affiliation  CHRISTIAN MEDICAL COLLEGE, VELLORE 
Address  Department of Anaesthesia,New Paul brand building,7th floor,Anaesthesia Office,CMC vellore Town Campus,Ida scudder road,Vellore-632004
20,VINAYAGAR STREET,KRISHNAPURAM COLONY, 7TH STREET,RAMALAKSHMI ILLAM, ALATHUR ,MADURAI-14
Madurai
TAMIL NADU
632004
India 
Phone  7538836784  
Fax    
Email  swethaalagarsamy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  BERNICE THEODRE 
Designation  ASSOCIATE PROFESSOR 
Affiliation  CHRISTIAN MEDICAL COLLEGE,VELLORE 
Address  Department of Anaesthesia,New Paul brand building,7th floor,Anaesthesia Office,CMC vellore Town Campus,Ida scudder road,Vellore-632004
Department of Anaesthesia,New Paul brand building,7th floor,Anaesthesia Office,CMC vellore Town Campus,Ida scudder road,Vellore-632004
Vellore
TAMIL NADU
632004
India 
Phone  9486843882  
Fax    
Email  berniceranjan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  PREETHI ELIZABETH KURYAN 
Designation  ASSISTANT PROFESSOR 
Affiliation  CHRISTIAN MEDICAL COLLEGE,VELLORE 
Address  Department of Anaesthesia,New Paul brand building,7th floor,Anaesthesia Office,CMC vellore Town Campus,Ida scudder road,Vellore-632004
Department of Anaesthesia,New Paul brand building,7th floor,Anaesthesia Office,CMC vellore Town Campus,Ida scudder road,Vellore-632004
Vellore
TAMIL NADU
632004
India 
Phone  7708720289  
Fax    
Email  preethikuryan@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Christian Medical College Department of Anaesthesia, New Paul brand building, 7th Floor, Anaesthesia Office, CMC Vellore Town Campus, Ida Scudder Road, Vellore – 632004, Tamil Nadu. 
 
Primary Sponsor  
Name  SWETHA A 
Address  Post graduate resident, Department of Anaesthesia,New Paul brand building,7th floor,Anaesthesia Office,CMC vellore Town Campus,Ida scudder road,Vellore-632004 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSWETHA A  CHRISTIAN MEDICAL COLLEGE  Department of Anaesthesia New Paul brand building 7th floor Anaesthesia Office CMC vellore Town Campus Ida scudder road Vellore 632004
Vellore
TAMIL NADU 
7538836784

swethaalagarsamy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional review board,christian medical college,vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  undergoing elective laparoscopic abdominoperineal excision surgeries 
 
ExclusionCriteria 
Details  Patient refusal
1.Patients with allergic history for local anesthetic drug
2. Patients with coagulopathies
3. Patients with active infection at injection site
4.Emergency surgeries
5. Conversion to open laparotomy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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.  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 Outcome  
Outcome  TimePoints 
1.Time for rescue analgesia.
2.Perineal pain score.
3.Number & timing of additional analgesic doses/interventions within the first 48h
4.Duration of effective block in hours. 
6,12,24 & 48 hours. 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 

 
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