HysteroscopyNCT06946121
Comparison Between the Intrauterine Lidocaine and Warm Saline Distention Medium for Pain Relief During Office Hysteroscopy
A study testing Lignocaine and Saline in people with Hysteroscopy, run by Cairo University at 1 site in Egypt.
Trial summary
Procedure: The procedure was done in the lithotomy position during the postmenstrual period. We used a 30° angle 2.9 mm rigid hysteroscopy with 3.8 mm diagnostic sheath [TEKNO®, LIGHT XA 180, Germany]. Vaginoscopic approach was used for insertion of the hysteroscopy in all cases (no use of speculum or tenaculum). Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Hysteroscopy
- What is being tested?
- Lignocaine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2024to 12 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥ 18 years old.
- Indications of diagnostic office hysteroscopy as:
- Suspicion of the intracavitary lesion. Abnormal uterine bleeding. Abnormal endometrial thickening. Postmenopausal bleeding. Mullerian congenital anomaly. Removal of foreign bodies. Undergoing the procedure to assess the endocervical canal, uterine cavity, and tubal ostia for infertility.
Who cannot join
- Patients with contra-indications of diagnostic hysteroscopy as:
- Unable to exclude pregnancy Acute pelvic infection Active genital herpes 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.
Trial locations and contacts
1 site in 1 country.
About this study
Procedure:
The procedure was done in the lithotomy position during the postmenstrual period.
Read more
We used a 30° angle 2.9 mm rigid hysteroscopy with 3.8 mm diagnostic sheath [TEKNO®, LIGHT XA 180, Germany].
Vaginoscopic approach was used for insertion of the hysteroscopy in all cases (no use of speculum or tenaculum).
The hysteroscopy was gently introduced into the uterine cavity after visualization of the cervix and identification of the external os.
We used saline as the distension medium and the maximum pressure was set at 70 to 80 mm Hg by an automated hysteroscopic pump system (Hysteromat II, Karl Storz), which automatically measured intrauterine fluid pressure. In lidocaine group: we added 5 ml of lidocaine 2% to 500 ml of saline solution that was used as a distention medium.
The uterine cavity and tubal ostia were systematically visualized. All procedures were done by an operator using the same equipment.
Read the detailed description
A written consent was taken from eligible women on admission after explaining the aim of the research, procedure, expected value, outcome, and possible adverse effects, with full details provided to them. They were informed that their participation in this study is voluntary and they may refuse to participate or withdraw from the study at any time.
After fulfilling inclusion and exclusion criteria, patients were equally randomized by simple randomization with a 1:1 allocation ratio into two groups using computer-generated random numbers. The envelopes were kept in the office hysteroscopy room in a closed box. Each of the envelopes was taken out of the box sequentially according to the order of women attendance.
Procedure:
The procedure was done in the lithotomy position during the postmenstrual period.
We used a 30° angle 2.9 mm rigid hysteroscopy with 3.8 mm diagnostic sheath [TEKNO®, LIGHT XA 180, Germany].
Vaginoscopic approach was used for insertion of the hysteroscopy in all cases (no use of speculum or tenaculum).
The hysteroscopy was gently introduced into the uterine cavity after visualization of the cervix and identification of the external os.
We used saline as the distension medium and the maximum pressure was set at 70 to 80 mm Hg by an automated hysteroscopic pump system (Hysteromat II, Karl Storz), which automatically measured intrauterine fluid pressure. In lidocaine group: we added 5 ml of lidocaine 2% to 500 ml of saline solution that was used as a distention medium.
The uterine cavity and tubal ostia were systematically visualized. All procedures were done by an operator using the same equipment.
- Conditions
- Hysteroscopy
- Being tested
- Lignocaine, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LignocaineDrug
50 women undergoing diagnostic outpatient office hysteroscopy proceeded by infusions of intrauterine lidocaine 2% and normal saline at room temperature.
SalineDrug
50 women undergoing diagnostic outpatient office hysteroscopy using warmed normal saline distention medium.
| Study group | Role | What they receive |
|---|---|---|
| Lignocaine group | Experimental | 50 women undergoing diagnostic outpatient office hysteroscopy proceeded by infusions of intrauterine lidocaine 2% and normal saline at room temperature. Receives: Drug: Lignocaine |
| Saline group | Placebo comparator | 50 women undergoing diagnostic outpatient office hysteroscopy using warmed normal saline distention medium Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
using visual analogue scale
Measured: at time of hysteroscopy and 15 minutes after it
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start30 Sep 2024
- Primary completion15 Feb 2025
- Study completion12 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysteroscopyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946121
- Sponsor's protocol ID
- 364
- Status last verified
- Apr 2025
- First submitted
- 19 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Intrauterine Lidocaine and Warm Saline Distention Medium for Pain Relief During Office Hysteroscopy
- ClinicalTrials.gov ID
- NCT06946121
- Acronym / sponsor ID
- 364
- Conditions
- Hysteroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 12 Apr 2025 (actual)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Procedure:
The procedure was done in the lithotomy position during the postmenstrual period.
We used a 30° angle 2.9 mm rigid hysteroscopy with 3.8 mm diagnostic sheath [TEKNO®, LIGHT XA 180, Germany].
Vaginoscopic approach was used for insertion of the hysteroscopy in all cases (no use of speculum or tenaculum).
The hysteroscopy was gently introduced into the uterine cavity after visualization of the cervix and identification of the external os.
We used saline as the distension medium and the maximum pressure was set at 70 to 80 mm Hg by an automated hysteroscopic pump system (Hysteromat II, Karl Storz), which automatically measured intrauterine fluid pressure. In lidocaine group: we added 5 ml of lidocaine 2% to 500 ml of saline solution that was used as a distention medium.
The uterine cavity and tubal ostia were systematically visualized. All procedures were done by an operator using the same equipment.
Detailed description
A written consent was taken from eligible women on admission after explaining the aim of the research, procedure, expected value, outcome, and possible adverse effects, with full details provided to them. They were informed that their participation in this study is voluntary and they may refuse to participate or withdraw from the study at any time.
After fulfilling inclusion and exclusion criteria, patients were equally randomized by simple randomization with a 1:1 allocation ratio into two groups using computer-generated random numbers. The envelopes were kept in the office hysteroscopy room in a closed box. Each of the envelopes was taken out of the box sequentially according to the order of women attendance.
Procedure:
The procedure was done in the lithotomy position during the postmenstrual period.
We used a 30° angle 2.9 mm rigid hysteroscopy with 3.8 mm diagnostic sheath [TEKNO®, LIGHT XA 180, Germany].
Vaginoscopic approach was used for insertion of the hysteroscopy in all cases (no use of speculum or tenaculum).
The hysteroscopy was gently introduced into the uterine cavity after visualization of the cervix and identification of the external os.
We used saline as the distension medium and the maximum pressure was set at 70 to 80 mm Hg by an automated hysteroscopic pump system (Hysteromat II, Karl Storz), which automatically measured intrauterine fluid pressure. In lidocaine group: we added 5 ml of lidocaine 2% to 500 ml of saline solution that was used as a distention medium.
The uterine cavity and tubal ostia were systematically visualized. All procedures were done by an operator using the same equipment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lignocaine group | Experimental | Drug: Lignocaine50 women undergoing diagnostic outpatient office hysteroscopy proceeded by infusions of intrauterine lidocaine 2% and normal saline at room temperature. |
| Saline group | Placebo comparator | Drug: Saline50 women undergoing diagnostic outpatient office hysteroscopy using warmed normal saline distention medium |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old.
- Suspicion of the intracavitary lesion. Abnormal uterine bleeding. Abnormal endometrial thickening. Postmenopausal bleeding. Mullerian congenital anomaly. Removal of foreign bodies. Undergoing the procedure to assess the endocervical canal, uterine cavity, and tubal ostia for infertility.
Key exclusion criteria (3 listed)
- Patients with contra-indications of diagnostic hysteroscopy as:
- Unable to exclude pregnancy Acute pelvic infection Active genital herpes 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lignocaine50 women undergoing diagnostic outpatient office hysteroscopy proceeded by infusions of intrauterine lidocaine 2% and normal saline at room temperature. | Drug | Lignocaine group |
| Saline50 women undergoing diagnostic outpatient office hysteroscopy using warmed normal saline distention medium. | Drug | Saline group |
Primary outcome
Pain score
Time frame: at time of hysteroscopy and 15 minutes after it
using visual analogue scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Hysteroscopy
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
Enrolling by invitationPhase 1
Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy
Abnormal Uterine Bleeding, Analgesia
RecruitingObservational study
Comparison of Operative Hysteroscopy and Vacuum Aspiration for Terminating First-trimester Pregnancy With Intrauterine Adhesions
Pregnancy Complicated With Intrauterine Adhesion
Recruiting
Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
Postmenopausal Women, Intrauterine Diseases
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Maged, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lignocaine and Saline in people with Hysteroscopy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: at time of hysteroscopy and 15 minutes after it). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.