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CTRI Number  CTRI/2024/06/069307 [Registered on: 20/06/2024] Trial Registered Prospectively
Last Modified On: 20/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   This is a clinical study for evaluation of pain relief following piles surgery using ultrasound guided pudendal nerve block. 
Scientific Title of Study   A comparative evaluation of ultrasound guided pudendal nerve block for postoperative analgesia in patients undergoing stapled hemorrhoidectomy.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Divesh Arora 
Designation  Director and HOD  
Affiliation  Asian Hospital Faridabad  
Address  Department of Anesthesia and OT services, 3rd floor, Asian Institute of medical sciences, Sector 21 A, badkal flyover road, Faridabad - 121002 HARYANA India

Faridabad
HARYANA
121002
India 
Phone  9650099113  
Fax    
Email  drdivesh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amit Choudhary 
Designation  DNB Resident  
Affiliation  Asian Hospital Faridabad  
Address  Department of Anesthesia and OT services, 3rd floor, Asian Institute of medical sciences, Sector 21 A, badkal flyover road, Faridabad - 121002 HARYANA India

Faridabad
HARYANA
121002
India 
Phone  7037134666  
Fax    
Email  akchaudhary798@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Divesh Arora 
Designation  Director and HOD  
Affiliation  Asian Hospital Faridabad  
Address  Department of Anesthesia and OT services, 3rd floor, Asian Institute of medical sciences, Sector 21 A, badkal flyover road, Faridabad - 121002 HARYANA India

Faridabad
HARYANA
121002
India 
Phone  9650099113  
Fax    
Email  drdivesh@gmail.com  
 
Source of Monetary or Material Support  
Asian Institute of medical sciences, Sector 21 A, badkal flyover road, Faridabad - 121002 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Divesh Arora  Asian Hospital Faridabad  Department of Anesthesia and OT services, 3rd floor, Asian Institute of medical sciences, Sector 21 A, badkal flyover road, Faridabad - 121002 Faridabad HARYANA
Faridabad
HARYANA 		 9650099113

drdivesh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE ASIAN HOSPITAL  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, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NO Block   Patients in this group will receive analgesics, intravenous Voveran 75 mg 12 th hourly and intravenous paracetamol 1 gm 6 th hourly.  
Intervention  Ultrasound guided pudendal nerve block.  Patients will receive 15 mls of injection ropivacaine 0.3% with 4 mg of dexamethasone on each side under ultrasound guidance using 22 G echogenic needle 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  • Patients undergoing stapled hemorrhoidectomy under GA

• American society of anesthesiology (ASA) grade 1 and 2 patients.
 
 
ExclusionCriteria 
Details  1. Patient refusal
2. ASA 3 and above
3. Patients with features of local infection at the site of block
4. Patients with history of bleeding disorder or on anticoagulant therapy
5. Patients with known allergy to local anesthetic drugs
6. Patients with mental illness
7. Patients with neuromuscular disorders
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Time of requirement of first rescue opioid analgesic.  0 , 4 , 8 ,12 and 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare overall requirements for Opioids in 24 hours.
2. Pain score.
3. Patient satisfaction score.
4. Side effects like nausea, vomiting and sedation.
 		 during first 24 hours. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   01/07/2024 
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 Yet Recruiting 
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   This is a clinical study designed to judge the efficacy of pudendal nerve block in patients undergoing stapled hemorrhoidectomy. This surgery is painful and use of regional analgesia technique as a part of multimodal analgesia regime is helpful for early rehabilitation of patient. 
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