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

NCT05610371 | Completed

• 1 other identifier: 0054-19-AAA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hysteroscopy; lidocaine; see and treat

Outcome Measures

Primary Outcomes (1)

• The change in pain using a 20cm-wide VAS scale

  Patients quantified their pain using a 20cm-wide VAS scale ruler, the score range being 0-10.

  The change from baseline , procedure (while inserting the hysteroscope through the cervix); during the operative procedure; immediately after the procedure and 15 minutes

Secondary Outcomes (1)

• the number of complications

  up to one month following the procedure

Study Arms (2)

Lidocaine The study group

EXPERIMENTAL

The study group underwent hysteroscopy using saline to which 10ml of 2% lidocaine was added to the first 1000 ml.

Drug: Lidocaine; Drug: Saline

Saline The control group

PLACEBO COMPARATOR

The control group underwent hysteroscopy using a saline distension medium.

Drug: Saline

Interventions

Lidocaine DRUG

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.

Also known as: Essracaine

Lidocaine The study group

Saline DRUG

The control group underwent hysteroscopy using a saline distension medium.

Also known as: Sodium chloride

Lidocaine The study group; Saline The control group

Eligibility Criteria

• Age: 20 Years - 52 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women between the ages of 20 years - 52 years inclusive.
• Undergoing SATH office hysteroscopy
• Patients are able to provide written consent

You may not qualify if:

• Previous Pelvic Inflammatory Disease (PID) or documented tubal occlusion
• Inability to consent due to cognitive or language barrier
• Allergy to Lidocaine
• Documented failed hysteroscopy prior to the current referral

Sponsors & Collaborators

• Assuta Ashdod Hospital: lead

Study Sites (1)

Assuta Ashdod University Hospital

Ashdod, Israel

Location

MeSH Terms

Interventions

Lidocaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Oshri Barel, MD

  Assuta Ashdod Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: RCT double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT double blind

Study Record Dates

• First Submitted: October 23, 2022
• First Posted: November 9, 2022
• Study Start: August 1, 2019
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-09

Locations

IL (1)