?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?.

?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?. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093561

Enrollment

Registered

2025-08-25

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N99- Intraoperative and postproceduralcomplications and disorders of genitourinary system, not elsewhere classified

Interventions

Intervention1: 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

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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 Timepoint: DURING PROCEDURE IMMEDIATELY AFTER 30 MINS POST PROCEDURE	—

Measure

Time frame

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 Timepoint: DURING PROCEDURE IMMEDIATELY AFTER 30 MINS POST PROCEDURE

—

Secondary

Measure	Time frame
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 Timepoint:	—

Measure

Time frame

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 Timepoint:

—

Countries

India

Contacts

Public ContactDr Veldi Srujana Laxman

AIIMS BIBINAGAR

draparnaj@gmail.com09834550107

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026