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Efficacy of Uterine Lidocaine Flushing in HyFoSy

Primary Purpose

To Evaluate the Efficacy of Flushing the Uterine Cavity With Lidocaine Before Hysterosalpingo-Foam Sonography to Reduce Procedure-related Pain

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
2% lidocaine
0.9 % normal saline
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for To Evaluate the Efficacy of Flushing the Uterine Cavity With Lidocaine Before Hysterosalpingo-Foam Sonography to Reduce Procedure-related Pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Yaakov MelcerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

'lidocaine flushing' group

Placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

visual analog scale (VAS) pain score
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).

Secondary Outcome Measures

Full Information

First Posted
June 7, 2020
Last Updated
July 26, 2020
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04433611
Brief Title
Efficacy of Uterine Lidocaine Flushing in HyFoSy
Official Title
Analgesic Efficacy of Intrauterine Lidocaine Flushing in Hysterosalpingo-foam Sonography: A Double-blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 17, 2020 (Actual)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
To Evaluate the Efficacy of Flushing the Uterine Cavity With Lidocaine Before Hysterosalpingo-Foam Sonography to Reduce Procedure-related Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
'lidocaine flushing' group
Arm Type
Experimental
Arm Description
intrauterine infusion of 2% lidocaine (Rafa laboratories, Israel) just prior to HyFoSy
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
intrauterine infusion of 0.9 % normal saline (placebo group) just prior to HyFoSy.
Intervention Type
Drug
Intervention Name(s)
2% lidocaine
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
0.9 % normal saline
Intervention Description
intrauterine infusion of 0.9 % normal saline
Primary Outcome Measure Information:
Title
visual analog scale (VAS) pain score
Description
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).
Time Frame
22 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yaakov Melcer, MD
Phone
0524551310
Email
ymeltcer@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaakov Melcer
Organizational Affiliation
Assaf-Harofeh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yaakov Melcer
City
Yavne
State/Province
Select A State Or Province
ZIP/Postal Code
8103908
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaakov Melcer
Phone
0524551310
Email
ymeltcer@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
1 year
Citations:
PubMed Identifier
33249268
Citation
Melcer Y, Nimrodi M, Levinsohn-Tavor O, Gal-Kochav M, Pekar-Zlotin M, Maymon R. Analgesic Efficacy of Intrauterine Lidocaine Flushing in Hysterosalpingo-foam Sonography: A Double-blind Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 Aug;28(8):1484-1489. doi: 10.1016/j.jmig.2020.11.019. Epub 2020 Nov 26.
Results Reference
derived

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Efficacy of Uterine Lidocaine Flushing in HyFoSy

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