Hysteroscopy Anesthesia for Relief of Pain (HARP)

Maimónides Biomedical Research Institute of Córdoba

Status: Not yet enrolling

Conditions: Pain Management; Local Anesthesia; Outpatient Hysteroscopy; Gynecologic Procedure; Procedural Pain Relief

Treatments: Other: Placebo; Procedure: Local paracervical Anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT07178379

HARP

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Patients in the control group will undergo a placebo-like intervention in which the vagina and cervix will be irrigated with 0.9% normal saline using a syringe, simulating the motion and timing of the anesthetic application without actual injection. This aims to reduce expectation bias. No active anesthetic agent will be used. Intervention Type: Placebo Comparator Substance: Saline (0.9% sodium chloride) Route: Vaginal and cervical irrigation Purpose: To serve as the control arm for comparison of pain levels in patients not receiving anesthetic injections.

Treatment:

Other: Placebo

Local Anesthesia (Mepivacaine 3%)

Experimental group

Description:

Patients in this group will receive an injection of 3% mepivacaine into the uterosacral ligaments before undergoing diagnostic hysteroscopy. The anesthetic will be administered using a 25 mm Carpule needle, with 3.4 mL injected into each uterosacral ligament under standard gynecological positioning. The procedure will begin approximately one minute after administration to allow time for the anesthetic effect. Intervention Type: Drug Drug Name: Mepivacaine 3% Dose and Route: Local injection - 6.8 mL total (3.4 mL per side) Purpose: To assess the effect of local anesthesia on pain perception during outpatient hysteroscopy.

Treatment:

Procedure: Local paracervical Anesthesia