| CTRI Number |
CTRI/2025/08/093090 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To check the amount of pain after haemorrhoid surgery by giving injection of methylene blue and Bupivacaine after surgery at surgical site |
|
Scientific Title of Study
|
Study to compare the post operative effect of local infiltration of methylene blue versus bupivacaine versus control group in post-operative recovery following haemorrhoidectomy |
| 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 Anand Dahariya |
| Designation |
Post MBBS DNB Resident |
| Affiliation |
Govt. R.D.B.P Jaipuria Hospital Jaipur |
| Address |
Room no 101, Department of General Surgery Govt. R.D.B.P Jaipuria Hospital [Attached with RUHS college of medical science] Milap Nagar JLN MARG Jaipur Rajasthan
Jaipur
RAJASTHAN
302018
India |
| Phone |
7999616305 |
| Fax |
|
| Email |
anandrdx360@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. SANCHIT JAIN |
| Designation |
Professor [department of general surgery |
| Affiliation |
Rajasthan medical council jaipur |
| Address |
6,Kailash vihar,Lal kothi, Tonk Road,JAIPUR RAJASTHAN
rajasthan medical council sardar patel marg,C-Scheme,jaipur Rajasthan 302001
Jaipur
RAJASTHAN
302015
India |
| Phone |
9829078825 |
| Fax |
|
| Email |
drsanchit@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand Dahariya |
| Designation |
Post MBBS DNB Resident |
| Affiliation |
Govt. R.D.B.P Jaipuria Hospital Jaipur |
| Address |
Room no. 101 Department of General Surgery Govt. R.D.B.P Jaipuria Hospital[Attached with RUHS College of Medical science] JLN MARG Milap Nagar Jaipur Rajasthan
Jaipur
RAJASTHAN
302018
India |
| Phone |
7999616305 |
| Fax |
|
| Email |
anandrdx360@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery Govt R.D.B.P JAIPURIA HOSPITAL, Milap nagar , JLN MARG jaipur rajasthan 302018 |
|
|
Primary Sponsor
|
| Name |
Govt RDBP jaipuria hospital attached with RUHS medical college |
| Address |
Govt R.D.B.P Jaipuria hospital ,Milap nagar ,tonk road ,jaipur rajasthan pin 302018 |
| 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 Anand Dahariya |
Govt R.D.B.P Jaipuria hospital attached with RUHS medical college |
Room no. 101 Department of General Surgery, Govt. R.D.B.P Jaipuria Hospital Milap Nagar Jaipur
Jaipur
RAJASTHAN |
07999616305
anandrdx360@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RUHS CMS-Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K642||Third degree hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INJECTION 0.5% BUPIVACAINE |
LOCAL INFILTRATION OF 0.5% BUPIVACAINE AFTER HAEMORRHOID SURGERY |
| Intervention |
Intervention of local infiltration of methylene blue |
Injection methylene blue 1% injected at incision site ( Local Infilteration) |
| Comparator Agent |
NORMAL SALINE 0.9% NS |
LOCAL INFILTRATION OF 0.9% NORMAL SALINE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients with grade3 and grade4 haemorrhiods
patients who has given written and informed consent |
|
| ExclusionCriteria |
| Details |
patient with recurrent anal surgery,fistula,fissure,pregnant women,stenosis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is an interventional approach in reduction of perianal pain after haemorrhiods surgery |
At 4 hours, 8 hours,12 hours, 24 hours and 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is an interventional approach for early recovery , minimize hospital & decrease consumption of analgesics post heamorrds surgery |
after surgery At 4 hours 8 hours 12 hours 24 hours 48 hours for analgesic consumption & for hospital stay at 24 hour & 48 hour |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
25/08/2025 |
| 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
|
The patients included in the study would be those scheduled for elective haemorrhoids surgery will be injected intradermally injection methylene blue and bupivacaine post haemorrhoidectomy to reduce perianal pain, early recovery and to minimize hospital stay. |