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Intrauterine Anesthesia in Operative, Awake, Office Hysteroscopy. A Randomized Double-blind Placebo-controlled Trial

NCT05610371 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-11-09

No results posted yet for this study

Summary

Objective: to evaluate intrauterine lidocaine infusion effectiveness in reducing pain associated with operative, awake office hysteroscopy Methods: A total of 100 patients will be randomized for this study The control group underwent hysteroscopy using a saline distension medium. The study group underwent hysteroscopy using 10ml of 2% lidocaine that was added to the first liter of distension medium. Patients quantified their pain using a 0-10 VAS score, at the following five predefined points: baseline, before the procedure; while inserting the hysteroscope through the cervix; during the operative procedure; immediately after the procedure and 15 minutes following the procedure.

Conditions

  • Anesthesia, Local
  • Office Hysteroscopy

Interventions

DRUG

Lidocaine

The study group underwent hysteroscopy using saline to which 10ml of 2% lidocaine was added to the first 1000 ml. This dose of lidocaine was calculated to allow maximal benefits with minimal potential complications. The maximal dose of lidocaine is 5mg\\kg in adults which translates to 200mg in a 40kg patient. We have set 200 mg as the maximal dose of lidocaine in our study, assuring the dosage is safe. The rest of the procedure following the first 1000ml of saline was completed using saline alone as needed.

DRUG

Saline

The control group underwent hysteroscopy using a saline distension medium.

Sponsors & Collaborators

  • Assuta Ashdod Hospital

    lead OTHER

Principal Investigators

  • Oshri Barel, MD · Assuta Ashdod Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
52 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2022-05-01
Completion
2022-05-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05610371 on ClinicalTrials.gov