Status:
NOT_YET_RECRUITING
Hysteroscopy Anesthesia for Relief of Pain
Lead Sponsor:
Maimónides Biomedical Research Institute of Córdoba
Conditions:
Pain Management
Outpatient Hysteroscopy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This randomized clinical trial aims to evaluate the effect of local anesthesia on pain perception in patients undergoing outpatient diagnostic hysteroscopy. Although generally well tolerated, pain dur...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age ≥ 18 years: To ensure that participants are legal adults and able to provide informed consent.
- Indication for office-based diagnostic hysteroscopy: The patient must be scheduled for a diagnostic hysteroscopy, either for uterine cavity evaluation or diagnostic purposes.
- Simple procedures like uterine polypectomies involving 1, 2, or more than 3 polyps or endometrial biopsy
- No previous hysteroscopies
- Exclusion Criteria
- Age \< 18 years
- Known allergy to any local anesthetic
- General contraindications to hysteroscopy including pregnancy (established via interview, last menstrual period, contraceptive use, or pregnancy test), active infection (e.g., pyometra or recent pelvic inflammatory disease), recent uterine perforation, etc.
- Complex procedures like myomectomy with morcellator
- Failure to access the uterine cavity
- Anatomic conditions preventing cavity access
- Excessive procedure duration or fluid use (fluid deficit \> 1000 cc)
- Known uterine malformations
- Waiting times exceeding 60 minutes
- Use of analgesic medication prior to the procedure
- Major complications related to the procedure including uterine perforation, creation of a false passage, or significant bleeding requiring interventions beyond standard care.
- Incomplete delivery of informed consent or failure to complete the pre-procedure anxiety questionnaire.
Exclusion
Key Trial Info
Start Date :
September 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT07178379
Start Date
September 6 2025
End Date
December 31 2025
Last Update
September 17 2025
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