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CTRI Number  CTRI/2024/10/074911 [Registered on: 08/10/2024] Trial Registered Prospectively
Last Modified On: 13/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A randomised trial comparing pain relief under spinal anesthesia versus local anesthesia in surgery for fissure in Ano. 
Scientific Title of Study   A randomised controlled trial on periprocedural analgesia among fissure in ano patients undergoing LIS under perianal versus saddle block anesthesia. 
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 Narendra Chhettri 
Designation  Resident (MS General Surgery) 
Affiliation  Armed Forces Medical College, Pune 
Address  Department of General Surgery, AFMC
Wanowrie, Pune
Pune
MAHARASHTRA
411040
India 
Phone  8605160257  
Fax    
Email  kshetri.narendra@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jafar Husain 
Designation  Associate Professor 
Affiliation  Armed Forces Medical College, Pune 
Address  Department of General Surgery, AFMC
Wanowrie, Pune
Pune
MAHARASHTRA
411040
India 
Phone  9673868394  
Fax    
Email  jafarhusain01@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jafar Husain 
Designation  Associate Professor 
Affiliation  Armed Forces Medical College, Pune 
Address  Department of General Surgery, AFMC
Wanowrie, Pune
Pune
MAHARASHTRA
411040
India 
Phone  9673868394  
Fax    
Email  jafarhusain01@gmail.com  
 
Source of Monetary or Material Support  
Armed Forces Medical College, Pune, 411040, Maharashtra, India 
 
Primary Sponsor  
Name  Armed Forces Medical College 
Address  Pune, 411040, Maharashtra, India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Narendra Chhettri  Armed Forces Medical College, Pune  Department of General Surgery, AFMC Pune, Wanowrie, Pune, 411040
Pune
MAHARASHTRA 
8605160257

kshetri.narendra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medical Research Cell and Institutional Ethical Committee, Armed Forces Medical College, Pune  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 
Intervention  Lateral Internal Sphincterotomy (LIS) Under Peri-anal Block  Infiltrated with 40 ml of 0.20 % ropivacaine. 6 ml each at 4 columns of 2 O Clock, 4 O Clock, 8 O clock and 10 O Clock and rest S/C infiltration around anal opening 
Comparator Agent  Lateral Internal Sphincterotomy (LIS) under Saddle Block  1.4 ml of 0.5 % Hyperbaric ropivacaine will be administered via 25 G Quincke needle into the Sub-arachnoid space at L4/L5 Interspace and Patient Kept in sitting position for 5-7 mins 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  i. Anal Fissure Patients undergoing LIS during the study period

ii. 18 years of age or older

iii. Able to give informed, written consent

iv. Classified by the American Society of Anaesthesiologists (ASA) as I and II 
 
ExclusionCriteria 
Details  i. Patients with other concurrent peri-anal pathologies
ii. Patient With history of previous peri-anal surgeries 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the peri-procedural pain relief for Lateral Internal Sphincterotomy in fissure in ano patients under peri- anal versus saddle block anesthesia by comparing VAS-P at 6 hours and 24 hours  6 hours and 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
(I) To compare the mean time to requirement of rescue analgesia after Lateral Internal Sphincterotomy in fissure in ano patients under peri- anal versus Saddle block anesthesia

(II) To compare the mean hospital stay after Lateral Internal Sphincterotomy in fissure in ano patients under peri- anal versus Saddle block anesthesia 
Not Applicable 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/10/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  
The majority of acute anal fissures resolve without surgical intervention. The goals of nonoperative therapy are straightforward and consist of three components. The first component is to remove the underlying pathology responsible for the creation of the fissure. This often means the alleviation of constipation and straining, as well as avoidance of other causes of anal trauma. Frequent sitz baths, stool softeners, adequate fluid intake and a high-fibre diet are recommended. The second component involves the relaxation of the internal anal sphincter to improve blood flow and allow healing. This can be achieved through topical nifedipine, topical nitro-glycerine or botulinum toxin injections. The third component consists of reducing the symptoms from the fissure, which are typically bleeding and pain. Topical analgesics such as 2% lidocaine jelly are usually prescribed.

Local application of muscle relaxing therapy may be used in healing chronic anal fissure when considerable risk for surgery is present. These therapies include nitro-glycerine ointment, botulinum toxin, calcium channel blockers (diltiazem or nifedipine), hydrocortisone or topical anaesthetic ointment principally lignocaine, sitz baths. These therapies esp. GTN offers symptomatic relief and anti-inflammatory effects and possibility of avoiding surgery.

When chronic fissures develop, healing is more difficult to achieve. Conservative methods are likely to fail and have a higher failure rate with chronically recurring anal fissures. In these situations, the gold standard is the lateral internal sphincterotomy (LIS). Lateral internal sphincterotomy is the surgical treatment of choice for refractory anal fissures and may be offered without pharmacologic treatment failure according to the practice parameters by the American Society of Colon and Rectal Surgeons.
Although these commonly performed anorectal operations are short in duration the dense sensory supply of the perineum leads to significant post-operative pain, making adequate anaesthesia crucial.

General or regional (spinal, caudal) anaesthesia is predominantly used for anorectal surgery. Ano-rectal surgeries performed under conventional anaesthesia (GA/SA) are fraught with numerous side effects, such as, drowsiness, headache, nausea, vomiting, sore throat, backache, post operative pain and urinary retention. In addition to the need for anaesthetists’ expertise, GA/SA impose restrictions on pre/post procedural oral intake & movement, necessitate close inpatient post operative monitoring and contribute towards additional operation room time consumption, making them rather patient and surgeon unfriendly.

In the recent years several studies explored the use of local anaesthesia for anorectal surgery as an outpatient procedure with encouraging results. But significant proportion of surgeons still tend to perform LIS in the hospital, using spinal anaesthesia despite associated side effects and burden of hospitalization.

The aim of this study is to further explore the viability of peri-anal block in Lateral Internal Sphincterotomy.

PRIMARY RESEARCH QUESTION:
Is Perianal Block equally efficacious as Saddle block anesthesia for peri-procedural pain relief in Lateral Internal Sphincterotomy for Anal Fissures?
NULL HYPOTHESIS:
Visual Analogue Scale – Pain (VAS-P) scores at 6 hours, 24 hours are higher among fissure in ano patients undergoing LIS under peri-anal block than fissure in ano patients undergoing LIS under saddle block.
 
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