NCT07178379: HARP

Hysteroscopy Anesthesia for Relief of Pain

Not yet recruiting NA Last updated 17 September 2025

What this trial tests

NA trial testing Local paracervical Anesthesia in Pain Management in 70 participants. Not yet recruiting.

Timeline

6 September 2025

Primary endpoint
31 October 2025

31 December 2025

Quick facts

Lead sponsor	Maimónides Biomedical Research Institute of Córdoba
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	70
Start date	6 September 2025
Primary completion	31 October 2025
Estimated completion	31 December 2025

Drugs / interventions tested

• Local paracervical Anesthesia
• Placebo

Conditions studied

• Pain Management — all drugs for Pain Management →
• Outpatient Hysteroscopy — all drugs for Outpatient Hysteroscopy →
• Local Anesthesia — all drugs for Local Anesthesia →
• Procedural Pain Relief — all drugs for Procedural Pain Relief →

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Who can join

18 and older, female only, with Pain Management or Outpatient Hysteroscopy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.