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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  
AIIMS PATNA BIHAR  
 
Primary Sponsor  
Name  Monika Kumari 
Address  Department of obstetrics and gynaecology aiims patna bihar 801507 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   NIL 
 
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  
Status 
Not Applicable 
 
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
 
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