| 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
|
|
|
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
|
|
|
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. |