Efficacy of Uterine Lidocaine Flushing in HyFoSy

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ClinicalTrials.gov Identifier: NCT04433611

Recruitment Status : Recruiting

First Posted : June 16, 2020

Last Update Posted : July 28, 2020

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Sponsor:

Information provided by (Responsible Party):

Assaf-Harofeh Medical Center

Study Description

Brief Summary:

To evaluate the efficacy of flushing the uterine cavity with lidocaine before Hysterosalpingo-Foam Sonography (HyFoSy) to reduce procedure-related pain.

Condition or disease	Intervention/treatment	Phase
To Evaluate the Efficacy of Flushing the Uterine Cavity With Lidocaine Before Hysterosalpingo-Foam Sonography to Reduce Procedure-related Pain	Drug: 2% lidocaine Drug: 0.9 % normal saline	Not Applicable

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Detailed Description:

This randomized, double-blind, placebo-controlled trial was approved by the institutional ethics committee (# 0189-19; approval 22-09-2019) and written informed consent was obtained from all participants. The sample was composed of women who were referred for tubal patency evaluation as part of their fertility workup. Exclusion criteria were a known allergy to lidocaine, unprotected intercourse, profuse vaginal bleeding and genital tract inflammation or infections (e.g. pelvic inflammatory disease (PID) or suspected sexually transmitted diseases (purulent vaginal discharge upon speculum insertion), salpingitis or tubo-ovarian abscess), psychological or neurological lesions affecting sensation, prior cervical surgery, cervical stenosis.

Randomization took place on the day of the procedure so that the staff had sufficient time to prepare the instruments and the medication/placebo. Women were randomized into one of two groups in a 1:1 ratio, using a predetermined randomization code, prepared by a research nurse. They were allocated to receive either: (1) an intrauterine infusion of 2% lidocaine (Rafa laboratories, Israel) ('lidocaine flushing' group), or (2) an intrauterine infusion of 0.9 % normal saline (placebo group) just prior to HyFoSy.

An assigned nurse prepared the medications according to the allocation group. Lidocaine and normal saline were placed in identical 10-mL disposable syringes. The lidocaine solution as well as the normal saline were both colorless and thus indistinguishable by the women and the performing sonographer, all of whom were blind to the group assignment.

No form of premedication was given before HyFoSy. The exam was performed after complete cessation of menstrual bleeding and before the 14th day of the ovulatory cycle. The women were placed in the supine position on an examination couch and a baseline transvaginal scan was performed by one of two experienced clinicians to detect any pelvic pathologies. A vaginal speculum was introduced into the vagina for visualization of the cervix. The cervix and vagina were cleansed with iodine solution. A balloon-less GIS catheter (GynaecologIQ)19 with a soft tapered tip was inserted into the endocervical canal for all HyFoSy procedures. The use of a tenaculum for uterine traction or a cervical dilatator to introduce the catheter was avoided in all cases. The speculum was then removed, taking care not to dislodge the catheter, and the ultrasound transducer was introduced vaginally. The abovementioned phase of the exam was performed by the same physician in all cases. The un-labelled solution (2% lidocaine solution or normal saline) was instilled slowly into the uterine cavity through the catheter until good distension and clear visualization of the uterine cavity was obtained. The ExEm® Foam-kit was used to produce foam according to the manufacturer's instructions9. The foam was then injected slowly via the GIS catheter under direct ultrasound guidance, until its passage or non-passage through both fallopian tubes had been assessed. All examinations were performed using a Samsung WS80A ultrasound system equipped with a V5-9 MHz endovaginal probe.

Pain scores were obtained before the procedure to collect a baseline value and were reassessed after the HyFoSy examination. All patients were asked to stay for 10-20 min in a waiting area and were asked to score the level of pain they experienced during the procedure on a visual analog scale (VAS) as described in20. The VAS consisted of a 10 cm line ranging from 0 to 10 (anchored by 0=no pain and 10=very severe pain). Patients were asked to mark the number that represented their perceived level of pain. Based on the VAS scores, the pain level ratings were classified as: mild (rated 1-3), moderate (4-6) or severe (7-10).

Sample size was calculated to detect 1 unit of mean difference of pain score between the two groups using the VAS, assuming that 1 was the SD (standard deviation) within the group. Twenty-seven women were needed in each group to reject the null hypothesis of 0.05 with a power of 0.9. Adding 30% to that number to compensate for any missing data gave a number of 39 women in each group.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	150 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Care Provider)
Primary Purpose:	Treatment
Official Title:	Analgesic Efficacy of Intrauterine Lidocaine Flushing in Hysterosalpingo-foam Sonography: A Double-blind Randomized Controlled Trial
Actual Study Start Date :	June 17, 2020
Estimated Primary Completion Date :	October 1, 2020
Estimated Study Completion Date :	December 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Lidocaine hydrochloride Lidocaine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 'lidocaine flushing' group intrauterine infusion of 2% lidocaine (Rafa laboratories, Israel) just prior to HyFoSy	Drug: 2% lidocaine intrauterine infusion of 2% lidocaine (Rafa laboratories, Israel) just prior to HyFoSy The VAS consisted of a 10 cm line ranging from 0 to 10 (anchored by 0=no pain and 10=very severe pain). Patients were asked to mark the number that represented their perceived level of pain. Based on the VAS scores, the pain level ratings were classified as: mild (rated 1-3), moderate (4-6) or severe (7-10).
Placebo Comparator: Placebo group intrauterine infusion of 0.9 % normal saline (placebo group) just prior to HyFoSy.	Drug: 0.9 % normal saline intrauterine infusion of 0.9 % normal saline

Arm

Intervention/treatment

Experimental: 'lidocaine flushing' group

intrauterine infusion of 2% lidocaine (Rafa laboratories, Israel) just prior to HyFoSy

Drug: 2% lidocaine

intrauterine infusion of 2% lidocaine (Rafa laboratories, Israel) just prior to HyFoSy

The VAS consisted of a 10 cm line ranging from 0 to 10 (anchored by 0=no pain and 10=very severe pain). Patients were asked to mark the number that represented their perceived level of pain. Based on the VAS scores, the pain level ratings were classified as: mild (rated 1-3), moderate (4-6) or severe (7-10).

Placebo Comparator: Placebo group

intrauterine infusion of 0.9 % normal saline (placebo group) just prior to HyFoSy.

Drug: 0.9 % normal saline

intrauterine infusion of 0.9 % normal saline

Outcome Measures

Primary Outcome Measures :

visual analog scale (VAS) pain score [ Time Frame: 22 months ]
The VAS consisted of a 10 cm line ranging from 0 to 10 (anchored by 0=no pain and 10=very severe pain). Patients were asked to mark the number that represented their perceived level of pain. Based on the VAS scores, the pain level ratings were classified as: mild (rated 1-3), moderate (4-6) or severe (7-10).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

*all women who were referred for tubal patency evaluation as part of their fertility workup.

Exclusion Criteria:

known allergy to lidocaine.
unprotected intercourse.
profuse vaginal bleeding and genital tract inflammation or infections (e.g. pelvic inflammatory disease (PID).
suspected sexually transmitted diseases (purulent vaginal discharge upon speculum insertion), salpingitis or tubo-ovarian abscess).
psychological or neurological lesions affecting sensation, prior cervical surgery, cervical stenosis.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04433611

Contacts

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Contact: Yaakov Melcer, MD	0524551310	ymeltcer@gmail.com

Locations

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Israel
Yaakov Melcer	Recruiting
Yavne, Select A State Or Province, Israel, 8103908
Contact: Yaakov Melcer 0524551310 ymeltcer@gmail.com

Sponsors and Collaborators

Assaf-Harofeh Medical Center

Investigators

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Principal Investigator:	Yaakov Melcer	Assaf-Harofeh Medical Center

More Information

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Responsible Party:	Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:	NCT04433611
Other Study ID Numbers:	# 0189-19
First Posted:	June 16, 2020 Key Record Dates
Last Update Posted:	July 28, 2020
Last Verified:	May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Supporting Materials:	Analytic Code
Time Frame:	1 year

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Flushing Skin Manifestations Lidocaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs	Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action

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