Gynecologic Procedure, Local Anesthesia, Outpatient Hysteroscopy, Pain Management, Procedural Pain Relief
Conditions
Keywords
hysteroscoy, outpatient hysteroscopy, pain assessment, visual analog scale, localanesthesia, ambulatory surgery, randomized controlled trial
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 during hysteroscopy remains a leading cause of procedural failure and patient discomfort. Current evidence on the effectiveness of local anesthetic techniques is limited, with considerable variability in study designs, patient populations, and outcomes measured. This study will compare pain levels between two groups: one receiving local anesthetic infiltration (3% mepivacaine into the uterosacral ligaments), and the other undergoing a placebo-like intervention (saline irrigation without injection). Pain will be assessed using a standardized Visual Analog Scale (VAS). The primary objective is to determine whether local anesthesia significantly reduces pain perception during the procedure. Secondary objectives include evaluating which patient or procedural variables may influence pain (e.g., parity, uterine position, BMI, operator experience) and whether local anesthesia impacts the need for post-procedural analgesia or complication rates. Patients will be randomly assigned in a 1:1 ratio using a simple randomization method. Although the study design does not allow for double blinding, efforts will be made to minimize expectation bias-patients will not be explicitly informed whether they are receiving anesthesia or not, and the placebo group will receive simulated intervention. The principal investigator and the statistician will be blinded to the treatment allocation during data analysis. Inclusion criteria are: age ≥ 18 years, indication for office-based diagnostic hysteroscopy or minor operative procedures (e.g., polypectomy or biopsy), and no previous hysteroscopy experience. Exclusion criteria include known anesthetic allergy, complex procedures (e.g., myomectomy), anatomic uterine malformations, severe complications, or lack of consent. A total sample size of 58 patients (29 per group) has been calculated based on an expected clinically relevant VAS difference of 1.5 points and a standard deviation of 2.0. To account for possible dropouts, up to 70 patients may be enrolled. The results of this trial will provide higher quality evidence on whether local anesthesia should be routinely recommended in outpatient hysteroscopy and may support cost-effectiveness studies in the future.
Interventions
PROCEDURELocal paracervical Anesthesia
1\. Intervention Group (Local Anesthesia) Name: Mepivacaine 3% uterosacral ligament block Type: Pharmacological (local anesthetic). Dose/Administration: Drug: Mepivacaine hydrochloride 3% (4 vials of 1.7 mL each, total 6.8 mL). Route: Bilateral injection into uterosacral ligaments (2 injections per ligament, 3.4 mL per side). Technique: Patient in lithotomy position. Uterosacral ligaments identified posteriorly to the cervix. Injection with a 27G Carpule needle (25 mm length) at 2-3 mm depth. Slow infusion (to minimize dispersion). Timing: Administered ≥1 minute before hysteroscopy.
OTHERPlacebo
Procedure: Vaginal and cervical irrigation with 0.9% saline solution (4 irrigations, mimicking anesthesia administration). Mimicry: Same equipment (syringe, speculum) as intervention group. Identical patient positioning and timing
Sponsors
Maimónides Biomedical Research Institute of Córdoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
This is a single-blind study with partial masking. Patients will not be explicitly informed whether they are receiving local anesthesia or placebo. In the control group, a simulated intervention (saline irrigation of the cervix and vagina) will be performed to mimic the anesthetic procedure. However, due to the nature of the intervention (injection of anesthetic vs. no injection), full blinding of patients is not feasible. The healthcare provider administering the intervention is not blinded, but both the principal investigator and the statistician will be blinded to group allocation during data analysis. This aims to reduce observer and analysis bias
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity during hysteroscopy | Immediately after the procedure | Pain will be measured using a 10-point Visual Analog Scale (VAS) immediately after the procedure. Patients will be asked to rate the maximum pain experienced during the hysteroscopy. Measure Type: Continuous (VAS score 0-10) Unit of Measure: Points on VAS scale Method of Aggregation: Mean (± SD) Statistical Analysis Plan: Comparison between groups using Student's t-test or Mann-Whitney U test depending on normality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for post-procedure analgesia | Within 30 minutes post-procedure | Whether patients required any analgesic medication after the hysteroscopy, and what type. Measure Type: Binary (Yes/No), plus qualitative record of analgesic used Unit of Measure: Proportion of patients (%) |
| Procedure-related complications | During and immediately after the procedure | Description: Recording of any intraoperative or immediate postoperative complications (e.g., vasovagal episodes, perforation, bleeding). Measure Type: Binary (Yes/No), with qualitative subtype Unit of Measure: Number of events |
| Indication for surgical hysteroscopy due to intolerable pain | Immediately post-procedure | Description: Whether the patient had to be referred for surgical hysteroscopy under anesthesia due to failure or intolerance of office hysteroscopy. Measure Type: Binary (Yes/No) Unit of Measure: Number of cases |
Contacts
Primary ContactJorge Garcia Fernandez, MD, Principal Investigator
Backup ContactPaula Caballero, MD, Collaborator, Investigator
Outcome results
None listed