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CTRI Number  CTRI/2025/08/093561 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 23/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   “A Randomised placebo-controlled trial to compare the efficacy of intrauterine lignocaine instillation with paracervical block in perimenopausal women undergoing outpatient endometrial biopsies at a tertiary care centre in Telangana”. 
Scientific Title of Study   “A Randomised placebo-controlled trial to compare the efficacy of intrauterine lignocaine instillation with paracervical block in perimenopausal women undergoing outpatient endometrial biopsies at a tertiary care centre in Telangana”. 
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 Veldi Srujana Laxman 
Designation  JR OBGY 
Affiliation  AIIMS BIBINAGAR 
Address  AIIMS BIBINAGAR, NALGONDA, TELANGANA

Nalgonda
TELANGANA
508126
India 
Phone  09834550107  
Fax    
Email  veldisrujana0402@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr APARNA J 
Designation  ASSOCIATE PROFESSOR OBGY 
Affiliation  AIIMS BIBINAGAR 
Address  AIIMS BIBINAGAR, NALGONDA, TELANGANA, INDIA 508126
AIIMS BIBINAGAR NALGONDA TELANGANA INDIA 508126
Nalgonda
TELANGANA
508126
India 
Phone  09834550107  
Fax    
Email  draparnaj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Veldi Srujana Laxman 
Designation  JR OBGY 
Affiliation  AIIMS BIBINAGAR 
Address  AIIMS BIBINAGAR, NALGONDA, TELANGANA

Nalgonda
TELANGANA
508126
India 
Phone  09834550107  
Fax    
Email  veldisrujana0402@gmail.com  
 
Source of Monetary or Material Support  
AIIMS BIBINAGAR, BIBINAGAR TELANGANA 508126 
 
Primary Sponsor  
Name  Dr Veldi Srujana 
Address  AIIMS BIBINAGAR, BIBINAGAR, TELANGANA, INDIA 508126 
Type of Sponsor  Other [primary investigator] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Aparna J  AIIMS BIBINAGAR 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Veldi Srujana Laxman  AIIMS BIBINAGAR  ROOM NO- 21, AIIMS BIBINAGAR OPD NALGONDA TELANAGANA
Nalgonda
TELANGANA 		 9834550107

veldisrujana0402@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE AIIMS-BBN  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N99||Intraoperative and postproceduralcomplications and disorders of genitourinary system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Paracervical block + Intrauterine normal saline  10 ml 0.9 % normal saline will be instilled intrauterine after PCB 
Intervention  paracervical block +intrauterine lignocaine  After 0.1 ml lignocaine intradermal test dose, for the paracervical block, 10 mL of 1% lignocaine without adrenaline will be injected at the 4 o’clock and 8 o’clock positions at the cervicovaginal junction with 22 G syringe. For the intrauterine anesthesia, 5 mL of 2% lignocaine will be instilled into the uterine cavity using a pediatric Foley catheter 8 Fr, or NG tube of 8 Fr, and the procedure will begin after waiting 5 minutes for the anesthetic to take effect. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  Perimenopausal women (40-55 years).
Patients without structural abnormalities of the uterus or cervix (e.g., no fibroids, uterine size less than 12 weeks, polyps, or cervical stenosis).
Patients who provide informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  Pregnant or breastfeeding women.
Patients with known allergies or contraindications to lignocaine, NSAID (Tab. Diclofenac)
Patients with uncontrolled hypertension, diabetes mellitus, thyroid disorders, history of epilepsy
Patients with contraindications to endometrial biopsy (e.g., active pelvic infection).
Patients with neurological or psychological disorders that may affect pain perception or response to anesthesia.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain Severity
Pain will be assessed using the Visual Analog Scale (VAS) before, immediately after, and 30 minutes post-procedure to compare pain levels between the two groups (intrauterine lignocaine vs. paracervical block).
Need for Additional Analgesia
The number of patients requiring additional analgesia or rescue medication (such as oral pain relievers) during or after the procedure will be recorded
 		 DURING PROCEDURE
IMMEDIATELY AFTER
30 MINS POST PROCEDURE
 
 
Secondary Outcome  
Outcome  TimePoints 
o Procedure Completion Time: The time taken to perform the endometrial biopsy (from insertion of the speculum to completion of the biopsy) will be measured for both groups to assess any potential impact of the pain management technique on the procedural efficiency.
o Adverse Effects: The occurrence of any adverse effects related to the anesthesia (e.g., allergic reactions, dizziness, nausea, or local complications) will be monitored and documented
 		  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   04/09/2025 
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="2"
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  

This study aims to evaluate the effectiveness of combining intrauterine lignocaine with paracervical block (PCB) versus PCB alone for pain relief during outpatient endometrial biopsy in perimenopausal women. Pain during this procedure often affects patient compliance and comfort. While PCB is commonly used, its efficacy is variable. Recent studies suggest intrauterine lignocaine may offer superior pain control. This randomized, placebo-controlled trial will compare pain scores, procedure duration, need for additional analgesia, and adverse effects between two groups—one receiving PCB with lignocaine and the other with saline. A total of 88 participants aged 40–55 years will be enrolled. Pain will be assessed using the Visual Analogue Scale (VAS) during and after the procedure. The outcome may support a multimodal analgesic approach for improved patient satisfaction. The study is feasible in outpatient settings and aligns with ongoing efforts to enhance gynecological care. Results could lead to standardized, evidence-based pain management protocols.

 
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