| 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
|
|
|
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
|
|
|
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. |