| CTRI Number |
CTRI/2025/07/090074 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [To compare the efficacy of Pain relief method in endometrial sampling ] |
| Study Design |
Other |
|
Public Title of Study
|
"Best Pain Relief Options for Women with Primary Infertility Undergoing Endometrial Aspiration: Comparing Diclofenac, Paracervical Block, and Their Combination"
|
|
Scientific Title of Study
|
Comparative Efficacy of Diclofenac Suppository, Paracervical Block, and Their Combination for Pain Relief during Endometrial Sampling in Women with Primary Infertility: An Open-ended, Three-Arm, Randomized Controlled Trial |
| 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 Deepak chitara |
| Designation |
Junior resident |
| Affiliation |
Aiims gorakhpur, uttar pradesh |
| Address |
Department of obstetrics & Gynecology ALL India Institute Of Medical sciences Gorakhpur.
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
6378588280 |
| Fax |
|
| Email |
deepakchitara1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr shikha seth |
| Designation |
Professor and Head of department, obstetrics and gynaecology ,aiims gorakhpur |
| Affiliation |
Aiims gorakhpur, uttar pradesh |
| Address |
Opd no 149 Department of obstetrics &Gynecology ALL India Institute Of Medical sciences Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
7827440230 |
| Fax |
|
| Email |
drseth_shikha@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr shikha seth |
| Designation |
Professor and Head of department, obstetrics and gynaecology ,aiims gorakhpur |
| Affiliation |
Aiims gorakhpur, uttar pradesh |
| Address |
Opd no.149 Department of obstetrics &Gynecology ALL India Institute Of Medical sciences Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
7827440230 |
| Fax |
|
| Email |
drseth_shikha@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of obstetrics and Gynecology Aiims Gorakhpur 273008, uttar pradesh,India |
|
|
Primary Sponsor
|
| Name |
Dr Deepak chitara |
| Address |
Department of obstetrics and Gynaecology All India Institute Of Medical sciences Gorakhpur 273008 uttar pradesh |
| 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 |
| Dr Deepak chitara |
All India Institute of medical sciences Gorakhpur |
Department of Obstetrics and Gynaecology All India Institute of medical sciences Gorakhpur 273008
Gorakhpur
UTTAR PRADESH |
6378588280
deepakchitara1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee All India Institute of Medical Sciences, Gorakhpur, India-273008 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
primary infertile women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
paracevical block |
10 ml of 1% lignocaine administered bilaterally at 4 and 8 clock position at the time of procedure |
| Intervention |
Diclofenac Suppository |
Rectal Diclofenac suppository 100mg 30 minutes Before the procedure |
| Intervention |
Diclofenac suppository + paracevical block |
100mg rectal diclofenac Suppository 30 minutes before the procedure + 10ml of 1% lignocaine as paracevical block at 4 and 8 clock |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
20 to 40yrs primary infertile women |
|
| ExclusionCriteria |
| Details |
Known Hypersensitive to NSAIDS or local anesthesic
Active pelvic infection
Coagulopathy or on anticoagulation therapy
Chronic pelvic pain and neurological disorders affecting pain perception
History of any past cervical surgery like LEEP |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean pain scores as assessed by visual analogue scale [VAS] at two time points- |
Immediately after endometrial sampling
30 minutes post procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Incidence of Adverse effects
2.Completion of procedure without the need for additional
analgesia
3. procedure ease as rated by the performing clinician on a 5 points likert scale |
At baseline & After procedure Completion. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/08/2025 |
| 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="6"
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
|
My thesis protocol is Comparative Efficacy of Diclofenac Suppository, Paracervical Block, and Their Combination for Pain Relief during Endometrial Sampling in Women with Primary Infertility. In which , I compare which one is better pain relief method [ assessed by visual analogue scale]or ease method [assessed by 5 point likert scale]during endometrial sampling.Also check Adverse effects and need of additional analgesia in this procedure |