“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”.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain Severity
研究概览
简要总结
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.
4o
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Pain Severity
时间窗: DURING PROCEDURE | IMMEDIATELY AFTER | 30 MINS POST PROCEDURE
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).
时间窗: DURING PROCEDURE | IMMEDIATELY AFTER | 30 MINS POST PROCEDURE
Need for Additional Analgesia
时间窗: DURING PROCEDURE | IMMEDIATELY AFTER | 30 MINS POST PROCEDURE
The number of patients requiring additional analgesia or rescue medication (such as oral pain relievers) during or after the procedure will be recorded
时间窗: DURING PROCEDURE | IMMEDIATELY AFTER | 30 MINS POST PROCEDURE
次要结局
- 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)
研究者
Dr Veldi Srujana Laxman
AIIMS BIBINAGAR