| CTRI Number |
CTRI/2026/02/103851 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain relief during the procedure for taking tissue sample from inner surface of uterus |
|
Scientific Title of Study
|
Analgesic efficacy of combined intrauterine lignocaine flushing and paracervical block in hysteroscopy guided endometrial biopsy - A 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 shreen |
| Designation |
post graduate |
| Affiliation |
sri manakula vinayagar medical college kalitheerthalkuppam pondicherry |
| Address |
NO 68 Department ofObstetrics and gyneacology Sri manakula vinayagar medical college and hospital
NO 68 Department of Obstetrics and gyneacology Sri manakula vinayagar medical college and hospital
Pondicherry
PONDICHERRY
605107
India |
| Phone |
6385759911 |
| Fax |
|
| Email |
shreenshaki@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.G.Poomalar |
| Designation |
post graduate |
| Affiliation |
sri manakula vinayagar medical college kalitheerthalkuppam pondicherry |
| Address |
NO 68 Department ofObstetrics and gyneacology Sri manakula vinayagar medical college and hospital
NO 68 Department of Obstetrics and gyneacology Sri manakula vinayagar medical college and hospital
Pondicherry
PONDICHERRY
605107
India |
| Phone |
09442044679 |
| Fax |
|
| Email |
poomalrpragash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr shreen |
| Designation |
post graduate |
| Affiliation |
sri manakula vinayagar medical college kalitheerthalkuppam pondicherry |
| Address |
NO 68 Department ofObstetrics and gyneacology Sri manakula vinayagar medical college and hospital
NO 68 Department of Obstetrics and gyneacology Sri manakula vinayagar medical college and hospital
Pondicherry
PONDICHERRY
605107
India |
| Phone |
6385759911 |
| Fax |
|
| Email |
shreenshaki@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri manakula vinayagar medical college and hospital ,madagadipet,kalitheerthalkupam,605107 |
|
|
Primary Sponsor
|
| Name |
Dr shreen |
| Address |
NO 68 Obstetrics and gyneacology department Sri manakula vinayagar medical college |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sri Manakula Vinayagar Medical College and Hospital |
Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthalkuppam, Puducherry |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shreen |
Sri Manakula Vinayagar Medical College and Hospital |
No 68, Department of obstetrics and gynecology, Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthalkuppam,
Pondicherry.
Pondicherry
PONDICHERRY |
6385759911
shreenshaki@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH-ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
normal saline and lignocaine |
lignocaine active agent and normal saline -no active agent |
| Intervention |
Paracervical block and intrauterine lignocaine flushing
normal saline |
intrauterine lignocaine flushing done using intrauterine insemination catheter with 2 % lignocaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
women of repoductive age group |
|
| ExclusionCriteria |
| Details |
1 Cervical stenosis
2 Cervical amputation
3 Allergy to lignocaine
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the analgesic efficacy of combined intrauterine lignocaine flushing and paracervical block versus paracervical block alone in women undergoing hysteroscopy guided biopsy. |
18 months from now |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the adverse effects of combined intrauterine lignocaine flushing & paracervical block versus paracervical block alone
2. To compare patient satisfaction during & after the procedure between the two groups
3. To compare surgeon satisfaction during the procedure in the two groups |
18 months from now |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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 3 |
|
Date of First Enrollment (India)
|
27/02/2026 |
| 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="3"
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
|
Diagnostic hysteroscopy is a minimally invasive technique in modern gynecological practice. It enables direct visualization of the uterine cavity, facilitating accurate evaluation and treatment of intrauterine pathologies in an outpatient setting. This procedure avoids the need for general anesthesia or hospitalization, enhancing patient comfort and reducing healthcare costs. Despite these benefits, pain remains a key concern in influencing patient compliance, procedural success, and satisfaction. Para cervical block (PCB) is the most common route of administration of local anesthetic agent in various gynecology procedures. There are other routes of lignocaine administration (lignocaine) apart from PCB, such as cervical infiltration, local spray onto cervix. Emerging evidence from the past decade supports the use of intrauterine 2% lignocaine flushing for pain relief in minor gynecology procedures. The concept behind intrauterine lignocaine instillation is that, there are different neuronal pathways supplying uterus and cervix which have synergistic effect. Autonomic nerve fibers arising from S2 to S4 roots and innervating the uterus in the base of broad ligament as the Frankenhauser plexus. The basis of paracervical block is to interrupt these dense plexuses. However, the uterus and cervix receive nerve supply from other sources as well. Sympathetic nerve fibers arising from T10 to L1 roots enters the uterus along the course of Uterine artery. So, combination of intrauterine lignocaine flushing and paracervical block can take care of both pathways. Hence, we aimed to study the analgesic efficacy of combination of intrauterine lignocaine flushing and PCB versus PCB alone in hysteroscopy guided biopsy |