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临床试验/CTRI/2026/01/101351
CTRI/2026/01/101351尚未招募不适用

Comparative Study of lignocaine gel versus lignocaine spray in addition to ibuprofen in pain management during hysterosalpingography - A Randomised controlled study

Monika Kumari1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2026年1月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
128
试验地点
1

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 49.00 Year(s)(—)
性别
Female

入选标准

  • All infertile women with primary or secondary infertility planned for hysterosalpingography.

排除标准

  • active vaginitis , PID , tubo ovarian mass , hydrosalpinx , active pelvic infections (TB) , h/o atopy to dye.

研究者

发起方
Monika Kumari
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Monika Kumari

AIIMS PATNA

研究点 (1)

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