| CTRI Number |
CTRI/2026/01/101351 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
01/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of lignocaine gel versus lignocaine spray in addition to ibuprofen in reducing pain during hysterosalpingography in primary or secondary infertile women |
|
Scientific Title of Study
|
Comparative Study of lignocaine gel versus lignocaine spray in addition to ibuprofen in pain management during hysterosalpingography - A Randomised controlled 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 |
Monika Kumari |
| Designation |
post graduate First year junior resident |
| Affiliation |
AIIMS PATNA |
| Address |
Obstetrics and gynaecology department , AIIMS PATNA
Patna BIHAR 801505 India |
| Phone |
08307433109 |
| Fax |
|
| Email |
monikakumari9609@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Indira prasad |
| Designation |
Additional professor |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Obstetrics and gynaecology aiims patna bihar
Patna BIHAR 801507 India |
| Phone |
8860033085 |
| Fax |
|
| Email |
indiralh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Shamshad ahmad |
| Designation |
Associate professor |
| Affiliation |
AIIMS PATNA |
| Address |
Department of community medicine aiims patna bihar
Patna BIHAR 801507 India |
| Phone |
7980084450 |
| Fax |
|
| Email |
drshamshadahmad@aiimspatna.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Monika Kumari |
| Address |
Department of obstetrics and gynaecology aiims patna bihar
801507 |
| Type of Sponsor |
Other [self] |
|
|
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 Indira Prasad |
AIIMS PATNA |
Department of obstetrics and gynaecology aiims patna bihar Patna BIHAR |
8860033085
drindirap@aiimspatna.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N971||Female infertility of tubal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lignocaine gel applied on cervix along with tab ibuprofen p/o |
400mg tab ibuprofen taken p/o 1 hour before the procedure with lignocaine gel 10% 1gm applied on cervix 10minutes before the procedure |
| Comparator Agent |
Lignocaine spray applied on cervix along with tab ibuprofen |
tab ibuprofen 400mg given p/o 1 hour before the procedure with lignocaine spray 2% 0.020gm on cervix 3 minute before the procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
All infertile women with primary or secondary infertility planned for hysterosalpingography |
|
| ExclusionCriteria |
| Details |
active vaginitis , PID , tubo ovarian mass , hydrosalpinx , active pelvic infections (TB) , h/o atopy to dye |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Comparing lignocaine gel and lignocaine spray plus ibuprofen for analgesia after 30min of procedure of hysterosalpingography as measured by the numerical rating scale |
9-12months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess efficacy in relieving pain specifically during application of teneculum between control (lignocaine and intervention arm
2. To assess efficacy in relieving pain during contrast dye instillation between control and intervention arm |
9-12months |
|
|
Target Sample Size
|
Total Sample Size="128" Sample Size from India="128"
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)
|
31/01/2026 |
| 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="1" 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
|
Hysterosalpingography is a commonly performed diagnostic procedure for evaluation of female infertility , particularly for assessing uterine cavity and tubal patency . Despite its clinical utility, HSG is frequently associated with mild to moderate pain, especially during cervical manipulation and contrast dye instillation, which can negatively affect patient comfort and compliance. Non-steroidal anti-inflammatory drugs such as ibuprofen and topical local anesthetics like lignocaine are routinely used to reduce pain; however, there is no standardized protocol regarding the optimal formulation of lignocaine for analgesia during HSG. This study is designed as a two-arm, open-label, randomized controlled trial to compare the analgesic efficacy of lignocaine gel plus oral ibuprofen versus lignocaine spray plus oral ibuprofen during hysterosalpingography. A total of 128 infertile women aged 18–49 years, undergoing HSG as part of infertility evaluation at AIIMS Patna, will be enrolled and randomized equally into two groups. Participants in Arm A will receive oral ibuprofen 400 mg one hour prior to the procedure along with topical application of lignocaine gel to the cervix 10 minutes before HSG. Participants in Arm B will receive oral ibuprofen 400 mg one hour prior to the procedure along with lignocaine spray applied to the cervix 3 minutes before HSG. Pain will be assessed using the Numerical Rating Scale NRS during tenaculum application, during contrast instillation, and 30 minutes after completion of the procedure. The primary outcome is comparison of post-procedure pain scores between the two groups. Secondary outcomes include pain during tenaculum application and during contrast dye instillation. The findings of this study are expected to help identify a more effective, simple, and evidence-based analgesic protocol for pain management during hysterosalpingography, thereby improving patient comfort and procedural acceptability |