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Lidocaine gel combined with ibuprofen versus ibuprofen alone for pain relief during an endometrial biopsy; A randomized controlled trial.

Lidocaine gel combined with ibuprofen versus ibuprofen alone for pain relief during an endometrial biopsy; A randomized controlled trial.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240620003
Enrollment
100
Registered
2024-06-20
Start date
2024-07-15
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Endometrial biopsy can cause moderate to severe pain during endometrial biopsy. Endometrial biopsy, lidocaine gel, ibuprofen, pain control

Interventions

Ibuprofen 400 mg orally 30 minutes before procedure. with 2% lidocaine gel ,3 mL, apply on all cervical surface and cervical canal.,Ibuprofen 400 mg orally 30 minutes before procedure. with Placebo ge
Experimental Drug,Placebo Comparator Drug
2% lidocaine gel with ibuprofen,KY jelly with ibuprofen

Sponsors

Khon Kaen Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >=18 years old. 2. Women who had an indication for an endometrial sampling: abnormal uterine bleeding in age >=35 years, age < 35 years with risk factors (history of unoppsed estrogen exposure, failed medical management, persistent abnormal uterine bleeding), abnormal uterine bleeding with tamoxifen taking, postmenopausal bleeding.

Exclusion criteria

Exclusion criteria: 1.Previous history of lidocaine allergy. 2.Previous history of NSAIDs allergy. 3.Previous history of sulfa drugs allergy. 4.History of gastric ulcer, gastritis, gastrointestinal bleeding. 5.Asthma. 6.Uncontrolled hypertension. 7.Bleeding disorder. 8.Kidney disease. 9.Liver disease. 10.G6PD deficiency. 11.Cardiac arrhythmias. 12.Coronary heart disease. 13.Uterine anomaly. 14.Massive vaginal bleeding. 15.Recieves misoprostol for cervical dilation. 16.Inability to give consent or participant in postoperative assessment owing to dementia, cognitive impairment or language barrier. 17. Unable to use visual analogue scale (VAS). 18. Ongoing vagina or cervix or pelvic infection. 19.Combination with endocervical biopsy. 20.Cervical stenosis. 21.Cannot pass instrument into endometriod cavity.

Design outcomes

Primary

MeasureTime frame
Pain score during aspiration during intervention VAS score

Secondary

MeasureTime frame
Pain score speculum insertion Before intervention VAS score,Pain score while grasping tenaculum while grasping tenaculum VAS score,Pain score immediately after biopsy immediately after biopsy VAS score,Pain score 10 minutes after procedure 10 minutes after procedure VAS score,Satisfaction score of patients after procedure questionnare,Satisfaction of physicians after procedure questionnare,Additional analgesic requirement after procedure questionnare ,Side effect of lidocaine gel, after procedure questionnare

Countries

Thailand

Contacts

Public ContactKemmanut Tueman

Khon Kaen hospital

numphetty.mw@gmail.com0889539451

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026