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CTRI Number  CTRI/2024/12/078514 [Registered on: 24/12/2024] Trial Registered Prospectively
Last Modified On: 21/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Role of pudendal nerve block in pain management after anorectal surgeries. 
Scientific Title of Study   Analgesic effectiveness of pudendal nerve block for postoperative pain management in anorectal surgery- randomized controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MARNANJAL KUMAR 
Designation  Junior Resident  
Affiliation  King Georges Medical University  
Address  Department of Anesthesiology, King Georges Medical University, Chowk

Lucknow
UTTAR PRADESH
226003
India 
Phone  9838655303  
Fax    
Email  marnanjalkv10a1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shefali Gautam 
Designation  Additional Professor 
Affiliation  King Georges Medical University  
Address  Department of Anesthesiology, King Georges Medical University, Chowk

Lucknow
UTTAR PRADESH
226003
India 
Phone  9559468440  
Fax    
Email  drshefaligautam@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shefali Gautam 
Designation  Additional Professor 
Affiliation  King Georges Medical University  
Address  Department of Anesthesiology, King Georges Medical University, Chowk

Lucknow
UTTAR PRADESH
226003
India 
Phone  9559468440  
Fax    
Email  drshefaligautam@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology, King Georges Medical University, Chowk, Lucknow, Uttar Pradesh, India  
 
Primary Sponsor  
Name  Marnanjal Kumar 
Address  Department of Anesthesiology, King Georges Medical University, Chowk, Lucknow, Uttar Pradesh, India  
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 
DR MARNANJAL KUMAR  King Georges Medical University  Department of Anesthesiology
Lucknow
UTTAR PRADESH 
05222258880

info@kgmcindia.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KING GEORGES MEDICAL UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  SADDLE BLOCK  WE WILL GIVE SADDLE BLOCK WITH BUPIVACAINE HEAVY(1.5 ML)  
Intervention  USG GUIDED PUDENDAL NERVE BLOCK  WE WILL GIVE SADDLE BLOCK WITH BUPIVACAINE HEAVY(1.5 ML) AND THEN WE GIVE PUDENDAL NERVE BLOCK WITH 0.25% LEVOBUPIVACAINE 5 ML ON EACH SIDE. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient of either sex of age group 18-60 years ,ASA I,II and III posted for elective haemorrhoidectomy surgery under saddle block 
 
ExclusionCriteria 
Details  Perianal suppurative lesions
Malignancy
Inflammatory bowel disease
ASA III & ASA IV
Contraindicated to regional Anesthesia.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
• To compare the postoperative pain with the help of Visual analogue score at 0,3,6,12 and 24 hrs   0,3,6,12 and 24 hrs  
 
Secondary Outcome  
Outcome  TimePoints 
To compare Requirement of total rescue analgesic and Total length of hospital stay
 
Extra drugs required and length of hospital stay 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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   Phase 2 
Date of First Enrollment (India)   20/01/2025 
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="1"
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  

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.

 
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