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| Name | Class |
|---|---|
| Aljazeera Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Hyoscine butylbromide and Placebo Spray | Experimental | 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. |
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| Topical lidocaine-prilocaine spray and placebo oral tablet | Active Comparator | 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. |
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| Double Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Hyoscine butylbromide and Placebo Spray | Drug | Hyoscine butylbromide 20 mg oral tablet, single dose, administered 30 minutes before HSG, plus placebo cervical spray applied to the ectocervix and external cervical os 10 minutes before HSG. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain during cervical instrumentation | 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 | Within 1 minute after tenaculum placement and cervical cannulation, before contrast injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain after speculum insertion before cervical instrumentation | Pain intensity will be assessed immediately after speculum insertion and before tenaculum placement or cervical cannulation using the 11-point Numerical Rating Scale for Pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain intensity. | Intra-procedure, immediately after speculum insertion and before cervical instrumentation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahmoud Alalfy, MD | Algezeera Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algezeera Hospital | Giza | Egypt |
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| ID | Term |
|---|---|
| D002086 | Butylscopolammonium Bromide |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D012602 | Scopolamine Derivatives |
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| Topical lidocaine-prilocaine spray and placebo oral tablet | Drug | Topical lidocaine-prilocaine spray, Manovipercaine Plus, EVA Pharma, Egypt, containing lidocaine 15% and prilocaine 5%, applied as three sprays to the ectocervix and external cervical os 10 minutes before HSG, plus placebo oral tablet administered 30 minutes before HSG. |
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| Double Placebo | Drug | Placebo oral tablet administered 30 minutes before HSG plus placebo cervical spray applied 10 minutes before HSG, at the same time points as the active interventions. |
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| Pain 30 minutes after HSG | Pain intensity will be assessed 30 minutes after completion of hysterosalpingography using the 11-point Numerical Rating Scale for Pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain intensity. | 30 minutes post-procedure |
| Patient satisfaction 30 minutes after HSG | Patient satisfaction with the procedure, measured using a 0-10 satisfaction scale, where 0 indicates no satisfaction and 10 indicates maximum satisfaction. | 30 minutes postprocedure |
| Pain during uterine filling | Pain intensity during or immediately after contrast injection at the end of uterine filling, measured using an 11-point numerical rating scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. | During HSG, at the end of uterine filling / immediately after contrast injection. |
| Post-procedure rescue analgesia | Number and percentage of participants requiring rescue analgesia after completion of the 30-minute post-procedure pain assessment. Rescue analgesia consisted of oral paracetamol 1,000 mg. | After the 30-minute post-procedure pain assessment. |
| Adverse events related to study medications or hysterosalpingography | Adverse events will be reported as the number and percentage of participants experiencing any adverse event potentially related to the study medications or the hysterosalpingography procedure. Events assessed will include dry mouth, nausea, dizziness, blurred vision, tachycardia, vasovagal reaction, allergic symptoms, local irritation or burning, and any other unexpected adverse event. | Periprocedural: during hysterosalpingography and up to 30 minutes after completion of the procedure. |
| Serious adverse events related to study medications or hysterosalpingography | Serious adverse events will be reported as the number and percentage of participants experiencing any serious adverse event during or after hysterosalpingography, including events requiring urgent medical intervention, hospital referral, or prolonged medical observation. | Periprocedural: during hysterosalpingography and up to 30 minutes after completion of the procedure. |
| D014326 |
| Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |