Effect of Warm Fluid Distension Media in Relieving Pain in Outpatient Hysteroscopy

Effect of Warm Fluid Distension Media in Relieving Pain in Outpatient Hysteroscopy: Randomized Controlled Trial.

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?

Study Overview

• Status: Completed
• Conditions: Office Hysteroscopy
• Intervention / Treatment: Procedure: warming saline media; Procedure: room temperature saline 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: warm saline; Patients who used warm saline as a distention media in office hysteroscopy	Procedure: warming saline media; use warm saline as a distention media in office hysteroscopy
SHAM_COMPARATOR: room temperature saline; Patients who used room temprature saline as a distention media in office hysteroscopy	Procedure: room temperature saline media; use room temperature saline as a distention media in office hysteroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
warm saline versus room temp. saline as a distention media in office hysteroscopy in reliving pain by usage of the visual analog scale (VAS)	The patient makes a mark on the visual analog scale line to indicate the intensity of her pain. Pain will be measured using a 10-cm visual analogue scale (VAS) graded from 0 to 10 , (0) means no pain (better outcome), and (10) means worst possible pain (worse outcome)	base line

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The clarity of the view.(questionnaire).	questionnaire including clear (better outcome) or dim (worse out come)	base line

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The ease of entry of the hysteroscopy.(questionnaire)	questionnaire including easy (better out come) difficult (worse out come)	base line
Patient satisfaction.(questionnaire)	questionnaire including yes (better outcome ) No (worse outcome)	base line
Time of the procedure.(time by minutes)	calculate time of each procedure by minutes	base line
complications (questionnaire)	questionnaire including No complications ( better outcome ) complications happen (worse outcome)	base line

Collaborators and Investigators

• Sponsor: Amira Mohamed

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2021
• Primary Completion (ACTUAL): October 30, 2021
• Study Completion (ACTUAL): December 30, 2021

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (ACTUAL): February 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: warm saline
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: FMASU MS 567/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No