| CTRI Number |
CTRI/2019/11/022053 [Registered on: 19/11/2019] Trial Registered Prospectively |
| Last Modified On: |
15/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Perianal blocks for ambulatory proctologic surgeries |
|
Scientific Title of Study
|
A COMAPARATIVE STUDY OF INTRA AND PERISPHINCTERIC PERIANAL BLOCKS FOR AMBULATORY PROCTOLOGIC SURGERIES |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lt Col R Saranga Bharathi |
| Designation |
Classified Specialist (Surgery) & GI Surgeon |
| Affiliation |
Command Hospital Central Command Lucknow |
| Address |
Department of GI Surgery
Command Hospital Central Command
Lucknow Cantonment
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
8554061554 |
| Fax |
05222480354 |
| Email |
sarangabharathi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lt Col R Saranga Bharathi |
| Designation |
Classified Specialist (Surgery) & GI Surgeon |
| Affiliation |
Command Hospital Central Command Lucknow |
| Address |
Department of GI Surgery
Command Hospital Central Command
Lucknow Cantonment
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
8554061554 |
| Fax |
05222480354 |
| Email |
sarangabharathi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anchal Awasthi |
| Designation |
Resident |
| Affiliation |
Command Hospital Central Command LucknowCommand Lucknow |
| Address |
Department of Surgery
Command Hospital Central Command
Lucknow Cantonment
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
7991962907 |
| Fax |
05222480354 |
| Email |
anchalawasthi85@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical Services |
| Address |
Command Hospital Central Command Lucknow Cantonment |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| LT COL R SARANGA BHARATHI |
Department of Gastrointestinal Surgery |
Command Hospital Central Command Lucknow Cantonment
Lucknow
UTTAR PRADESH |
8554061554
05222480354
sarangabharathi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| COMMAND HOSPITAL CENTRAL COMMAND ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K605||Anorectal fistula, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intrasphicteric block |
Cocktail of local anaesthetic agents bupivacaine and lignocaine 20 ml each to be administered into the anal sphincter |
| Comparator Agent |
Perisphincteric block |
Cocktail of local anaesthetic agents Bupivacaine and Lignocaine 20 ml each to be injected around the anal sphincter |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients with benign anorectal conditions warranting surgery |
|
| ExclusionCriteria |
| Details |
Patients unwilling for the trial
Patients unwilling for local anaesthesia
Patients allergic to local anaesthetic agents
Paediatric patients
Patients with bleeding disorders
Patients in anticoagulants
Patients with acute perianal suppuration
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia |
Hours and minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for onset of anaesthesia |
Minutes |
| Degree of anal gaping |
Finger width |
| Ease of administration of anaesthesia |
Mild moderate or severe |
| Pain felt by patient while administering local anaesthesia |
Mild moderate or severe |
| Ease of performing surgery |
Easy, mild difficulty, moderate difficulty or severe difficulty |
| Duration of anaesthesia |
Hours and minutes |
| Complications |
As per Clavein Dindo scale |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
09/12/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ambulatory proctologic surgeries can well be performed under local blocks. Intra sphincteric and perisphincteric blocks are two different types of blocks that are commonly employed to block the nerve supply to ano-rectum to permit surgeries in ano-rectal region. Hitherto, no study has compared the efficacy of these two types of blocks for ambulatory proctologic surgeries. This study aims to do so. |