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

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

August 1, 2019

Primary Completion Date

May 1, 2022

Study Completion Date

May 1, 2022

Conditions
Anesthesia, LocalOffice 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.

Trial Locations (1)

Unknown

Assuta Ashdod University Hospital, Ashdod

All Listed Sponsors
lead

Assuta Ashdod Hospital

OTHER

NCT05610371 - Intrauterine Anesthesia in Operative, Awake, Office Hysteroscopy. A Randomized Double-blind Placebo-controlled Trial | Biotech Hunter | Biotech Hunter