Oral Hyoscine Butylbromide Versus Topical Lidocaine-Prilocaine Spray Versus Placebo for Pain Relief During Hysterosalpingography: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Pain during cervical instrumentation
研究概览
简要总结
This single-centre, three-arm, randomised, double-blind, double-dummy, placebo-controlled trial evaluated the efficacy and safety of oral hyoscine butylbromide, topical lidocaine-prilocaine spray and placebo for reducing pain during hysterosalpingography in women with primary infertility. Pain was self-rated using an 11-point numerical rating scale at predefined procedural time points, including cervical instrumentation and uterine filling.
详细描述
This was a single-centre, three-arm, randomised, double-blind, double-dummy, placebo-controlled trial conducted at the Department of Obstetrics and Gynaecology, Al Gezeera Hospital, Giza, Egypt. Women aged 18-40 years with primary infertility scheduled for hysterosalpingography during the early proliferative phase of the menstrual cycle were randomly assigned in a 1:1:1 ratio to receive oral hyoscine butylbromide 20 mg with placebo cervical spray, topical lidocaine-prilocaine spray with placebo oral tablet, or double placebo. A double-dummy technique was used to preserve blinding across oral and topical routes of administration. Pain was assessed using a 0-10 numerical rating scale at predefined procedural time points. The primary outcome was pain during cervical instrumentation. Secondary outcomes included pain during uterine filling, pain after speculum insertion, pain 30 minutes after the procedure, patient satisfaction, rescue analgesia and adverse events.Before recruitment and randomisation of the first participant, the protocol was amended and approved by the Research Ethics Committee to specify the topical lidocaine-prilocaine spray formulation and the final outcome hierarchy described below. The registry record was subsequently updated during final study-data updating to reflect the approved amended protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 to 40 years
- •Primary infertility
- •Scheduled to undergo hysterosalpingography as part of routine infertility evaluation
- •Regular menstrual cycles
- •Hysterosalpingography scheduled during the early proliferative phase of the menstrual cycle, days 6 to 12
- •Negative urine pregnancy test on the day of the procedure
- •Able to understand and use the 0 to 10 Numerical Rating Scale for Pain assessment
排除标准
- •Secondary infertility
- •Known hypersensitivity to hyoscine, lidocaine, or prilocaine
- •Use of systemic analgesics, sedatives, or antispasmodics within 24 hours before hysterosalpingography
- •Chronic pelvic pain or severe dysmenorrhoea requiring regular analgesia
- •Active pelvic infection
- •Known uterine anomaly
- •Cervical stenosis necessitating anaesthesia
- •History of contrast allergy
- •Inability to cooperate with numerical pain scoring
- •Current pregnancy
- •Severe systemic disease corresponding to American Society of Anesthesiologists physical status class III or higher
研究组 & 干预措施
Oral Hyoscine butylbromide and Placebo Spray
Participants received a single 20 mg oral tablet of hyoscine butylbromide 30 minutes before hysterosalpingography, together with placebo cervical spray applied 10 minutes before the procedure.
干预措施: Oral Hyoscine butylbromide and Placebo Spray (Drug)
Double Placebo
Participants received a placebo oral tablet 30 minutes before HSG and placebo cervical spray applied to the ectocervix and external cervical os 10 minutes before the procedure.
干预措施: Double Placebo (Drug)
Topical lidocaine-prilocaine spray and placebo oral tablet
Participants received topical lidocaine-prilocaine spray applied as three sprays to the ectocervix and external cervical os 10 minutes before hysterosalpingography, together with a placebo oral tablet given 30 minutes before the procedure.
干预措施: Topical lidocaine-prilocaine spray and placebo oral tablet (Drug)
结局指标
主要结局
Pain during cervical instrumentation
时间窗: Within 1 minute after tenaculum placement and cervical cannulation, before contrast injection.
Pain intensity during cervical instrumentation, including tenaculum placement and cervical cannulation, measured using an 11-point numerical rating scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable
Pain intensity (VAS) during cervical instrumentation (after tenaculum and cannula placement)
时间窗: IMMEDIATE(1 MINUTE)
Pain will be measured using a 0-10 Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable
Pain at end of uterine filling
时间窗: INTRA-PROCEDURE
"Pain will be measured using a 0-10 Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable
次要结局
- Pain after speculum insertion before cervical instrumentation(Intra-procedure, immediately after speculum insertion and before cervical instrumentation.)
- Pain 30 minutes after HSG(30 minutes post-procedure)
- Patient satisfaction 30 minutes after HSG(30 minutes postprocedure)
- Pain during uterine filling(During HSG, at the end of uterine filling / immediately after contrast injection.)
- Post-procedure rescue analgesia(After the 30-minute post-procedure pain assessment.)
- Adverse events related to study medications or hysterosalpingography(Periprocedural: during hysterosalpingography and up to 30 minutes after completion of the procedure.)
- Serious adverse events related to study medications or hysterosalpingography(Periprocedural: during hysterosalpingography and up to 30 minutes after completion of the procedure.)
- Baseline pain after speculum insertion(INTRAPROCEDURE)
- pain 30 minutes post procedure(30 minutes post-procedure)
- women satisfaction(30 minutes postprocedure)