An interventional study of Lignocaine and Saline in Hysteroscopy, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-04-27.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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.
Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age ≥ 18 years old.
Indications of diagnostic office hysteroscopy as:
Suspicion of the intracavitary lesion. Abnormal uterine bleeding. Abnormal endometrial thickening. bleeding. Mullerian congenital anomaly. Removal of foreign bodies. Undergoing the procedure to assess the endocervical canal, uterine cavity, and tubal ostia for infertility.
Exclusion Criteria:
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, and adhesiolysis.
Patient refusal to participate in the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
50 women undergoing diagnostic outpatient office hysteroscopy proceeded by infusions of intrauterine lidocaine 2% and normal saline at room temperature.
Drug: Lignocaine
50 women undergoing diagnostic outpatient office hysteroscopy using warmed normal saline distention medium
Drug: Saline
50 women undergoing diagnostic outpatient office hysteroscopy proceeded by infusions of intrauterine lidocaine 2% and normal saline at room temperature.
50 women undergoing diagnostic outpatient office hysteroscopy using warmed normal saline distention medium.
Pain score
using visual analogue scale
Time frame: at time of hysteroscopy and 15 minutes after it
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine