Comparison Between the Intrauterine Lidocaine and Warm Saline Distention Medium for Pain Relief During Office Hysteroscopy

NCT06946121 | Completed DMC

• 1 other identifier: 364
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (1)

• Pain score

  using visual analogue scale

  at time of hysteroscopy and 15 minutes after it

Study Arms (2)

Lignocaine group

EXPERIMENTAL

50 women undergoing diagnostic outpatient office hysteroscopy proceeded by infusions of intrauterine lidocaine 2% and normal saline at room temperature.

Drug: Lignocaine

Saline group

PLACEBO COMPARATOR

50 women undergoing diagnostic outpatient office hysteroscopy using warmed normal saline distention medium

Drug: Saline

Interventions

Lignocaine DRUG

50 women undergoing diagnostic outpatient office hysteroscopy proceeded by infusions of intrauterine lidocaine 2% and normal saline at room temperature.

Lignocaine group

Saline DRUG

50 women undergoing diagnostic outpatient office hysteroscopy using warmed normal saline distention medium.

Saline group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

Location

MeSH Terms

Interventions

Lidocaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ahmed Maged, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 19, 2025
• First Posted: April 27, 2025
• Study Start: September 30, 2024
• Primary Completion: February 15, 2025
• Study Completion: April 12, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

EG (1)