| CTRI Number |
CTRI/2026/02/102668 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
31/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of intradermal methylene blue injection on postoperative Pain relief in haemorrhoidectomy - a randomized control study |
|
Scientific Title of Study
|
Efficacy of intradermal methylene blue infiltration on postoperative analgesia in haemorrhoidectomy - a randomized control study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushanta Kumar Das |
| Designation |
Professor |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of General Surgery, Kalinga Institute of Medical Sciences Kushabhadra Campus, 5, KIIT Rd, Bhubaneswar, Odisha 751024, India
Khordha
ORISSA
751024
India |
| Phone |
9238507404 |
| Fax |
|
| Email |
sushanta.das@kims.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Rishi Middha |
| Designation |
Post Graduate Trainee |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of General Surgery, Kalinga Institute of Medical Sciences Kushabhadra Campus, 5, KIIT Rd, Bhubaneswar, Odisha 751024, India
Khordha
ORISSA
751024
India |
| Phone |
8826423431 |
| Fax |
|
| Email |
rishimiddha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rishi Middha |
| Designation |
Post Graduate Trainee |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of General Surgery, Kalinga Institute of Medical Sciences Kushabhadra Campus, 5, KIIT Rd, Bhubaneswar, Odisha 751024, India
Khordha
ORISSA
751024
India |
| Phone |
8826423431 |
| Fax |
|
| Email |
rishimiddha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rishi Middha |
| Address |
DEPARTMENT OF GENERAL SURGERY, KALINGA INSTITUTE OF MEDICAL SCIENCES |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
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 |
| Rishi Middha |
Kalinga Institute of Medical Sciences |
Department of surgery, 1st Floor, KIMS, Kushabhadra Campus, 5, KIIT Rd, Bhubaneswar, Odisha 751024, India
Khordha
ORISSA |
8826423431
rishimiddha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC KIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K642||Third degree hemorrhoids, (2) ICD-10 Condition: K643||Fourth degree hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacine |
Intradermal Bupivacaine infiltration in perianal skin post haemorrhoidectomy |
| Intervention |
Methylene Blue with Bupivacaine |
Intradermal Methylene Blue with Bupivacaine infiltration in perianal skin post haemorrhoidectomy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing haemorrhoidectomy in KIMS, Deparment of General Surgery |
|
| ExclusionCriteria |
| Details |
- Pregnant and Breast feeding female
- Allergic to Methlene Blue
- Patient having any other perianal condition
- Patient not giving consent to be a part of the study |
|
|
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measurement of Visual Analogue Score on DAYS 1-3 |
Day 1 and Day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparision of decrease in requirement of postoperative analgesics between the two groups |
Day 1 & Day 3 |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
12/02/2026 |
| 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="2"
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 STUDY IS BEING DONE IN AN EFFORT TO REDUCE THE POST OPERATIVE PAIN AND THE NEED FOR POST OPERATIVE ANALGESIA IN CASE OF HAEMORRHOIDECTOMY WITH THE HYPOTHESIS BEING THAT INTRADERMAL PERIANAL INFILTRATION OF METHYLENE BLUE RESULTS IN A DECREASE IN THE POSTOPERATIVE PAIN DUE TO TEMPORARY ABLATION OF CUTANEOUS NERVE ENDINGS BY BLOCKING VOLTAGE GATED SODIUM CHANNELS |