Clinical trial NCT05246436: Effect of Warm Fluid Distension Media in Relieving Pain in Outpatient Hysteroscopy
Official title: Effect of Warm Fluid Distension Media in Relieving Pain in Outpatient Hysteroscopy: Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Office Hysteroscopy
Keywords: warm saline
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of study is to determine if the use of warm saline distention media during outpatient hysteroscopy reduces Pain/discomfort of the procedure.

Research hypothesis: In women undergoing office hysteroscopy, there will be reduced pain perception when using warm saline (body temperature 37°C during office hysteroscopy.

Research question: In women undergoing office hysteroscopy, Will there be a difference in pain perceived during the procedure if the investigators use warm saline(body temperature 37°C) rather than normal saline (room temperature) as a distension media?

Detailed description: Office hysteroscopy is a procedure where a doctor uses a thin tube with a tiny camera to look inside the uterus. There are no incisions. Saline solution is used to expand the uterus in order to look at the inside of the uterus .

The vaginoscopic 'non-touch' technique first described by Bettocchi and Selvaggi (1997) has avoided the need for using a speculum and tenaculum in outpatient hysteroscopy; miniaturization of fibreoptic instruments has also enabled the procedure to be conducted without intra- or paracervical anesthesia.

Indications for diagnostic \& therapeutic outpatient hysteroscopy include abnormal uterine bleeding, reproductive problems, glandular abnormalities on cervical smear, identification and retrieval of lost intrauterine devices, polypectomy, endometrial ablation and myomectomy.

Hysteroscopic procedures can be successfully performed in an office setting without any anesthesia.

There are pharmacological and non pharmacological analgesic methods. Non pharmacological methods, such as vaginoscopy or mini hysteroscopes, are advisable to avoid producing pain . The pharmacological method including intervention method which is para cervical block, reducing pain during and 30 minutes after hysteroscopy. And medical methods such as Non steroidal anti-inflammatory drugs (NSAIDs) seem to be useful in the postoperative period. Evidence is not clear about combination of techniques or misoprostol .

Endometrial cavity is an empty cavity and requires distension to permit visualization. Therefore, during hysteroscopy either fluid or carbon dioxide gas is used to enlarge the endometrial cavity. To achieve a panoramic view, the uterine walls must be forcibly separated. The thick muscle of uterine walls needs a minimum pressure of 40 mm Hg to distend the cavity adequately for hysteroscopic visualization.

Normal saline is usually recommended as the distention medium in outpatient hysteroscopy as it allows improved image resolution and is associated with less vasovagal episodes compared with carbon dioxide. Although it is thought that uterine contractility could be provoked by instillation of saline at lower temperatures, there is little data on the effect of temperature on clarity of image, discomfort/pain, outcome of the procedure and patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* - Age ≥ 18 years old.
* Indications of diagnostic hysteroscopy: Cases complaining of abnormal uterine bleeding and /or undergoing the procedure to assess the endocervical canal, uterine cavity, and tubal Ostia for infertility, removal of foreign body, Suspected Mullerian anomalies.

Exclusion Criteria:

* - Contra-indications of diagnostic hysteroscopy: unable to exclude pregnancy, acute pelvic infection, active genital herpes, confirmed cervical or endometrial cancer and profuse bleeding at the time of the procedure.
* Any usage of analgesic agent on the day of the procedure.
* Failure of entry of the cervical canal requiring cervical dilatation.
* Any additional procedure during the procedure: polypectomy, biopsy and adhesiolysis.
* Patient refusal to participate in the study.

Primary outcomes:
measure: warm saline versus room temp. saline as a distention media in office hysteroscopy in reliving pain by usage of the visual analog scale (VAS)
timeFrame: base line
Secondary outcomes:
measure: The clarity of the view.(questionnaire).
timeFrame: base line
Other outcomes:
measure: The ease of entry of the hysteroscopy.(questionnaire)
timeFrame: base line
measure: Patient satisfaction.(questionnaire)
timeFrame: base line
measure: Time of the procedure.(time by minutes)
timeFrame: base line
measure: complications (questionnaire)
timeFrame: base line
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
Study officials:
References:
citation: Issat T, Beta J, Nowicka MA, Durczynski A, Jakimiuk AJ. Pain assessment during outpatient hysteroscopy using room temperature versus warm normal saline solution as a distention medium - a prospective randomized study. Clin Exp Obstet Gynecol. 2017;44(3):359-363.