Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
70 participants
INTERVENTIONAL
2025-09-06
2025-12-31
Brief Summary
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This study will compare pain levels between two groups: one receiving local anesthetic infiltration (3% mepivacaine into the uterosacral ligaments), and the other undergoing a placebo-like intervention (saline irrigation without injection). Pain will be assessed using a standardized Visual Analog Scale (VAS).
The primary objective is to determine whether local anesthesia significantly reduces pain perception during the procedure. Secondary objectives include evaluating which patient or procedural variables may influence pain (e.g., parity, uterine position, BMI, operator experience) and whether local anesthesia impacts the need for post-procedural analgesia or complication rates.
Patients will be randomly assigned in a 1:1 ratio using a simple randomization method. Although the study design does not allow for double blinding, efforts will be made to minimize expectation bias-patients will not be explicitly informed whether they are receiving anesthesia or not, and the placebo group will receive simulated intervention. The principal investigator and the statistician will be blinded to the treatment allocation during data analysis.
Inclusion criteria are: age ≥ 18 years, indication for office-based diagnostic hysteroscopy or minor operative procedures (e.g., polypectomy or biopsy), and no previous hysteroscopy experience. Exclusion criteria include known anesthetic allergy, complex procedures (e.g., myomectomy), anatomic uterine malformations, severe complications, or lack of consent.
A total sample size of 58 patients (29 per group) has been calculated based on an expected clinically relevant VAS difference of 1.5 points and a standard deviation of 2.0. To account for possible dropouts, up to 70 patients may be enrolled.
The results of this trial will provide higher quality evidence on whether local anesthesia should be routinely recommended in outpatient hysteroscopy and may support cost-effectiveness studies in the future.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
The healthcare provider administering the intervention is not blinded, but both the principal investigator and the statistician will be blinded to group allocation during data analysis. This aims to reduce observer and analysis bias
Study Groups
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Control
Patients in the control group will undergo a placebo-like intervention in which the vagina and cervix will be irrigated with 0.9% normal saline using a syringe, simulating the motion and timing of the anesthetic application without actual injection. This aims to reduce expectation bias. No active anesthetic agent will be used.
Intervention Type: Placebo Comparator Substance: Saline (0.9% sodium chloride) Route: Vaginal and cervical irrigation Purpose: To serve as the control arm for comparison of pain levels in patients not receiving anesthetic injections.
Placebo
Procedure:
Vaginal and cervical irrigation with 0.9% saline solution (4 irrigations, mimicking anesthesia administration).
Mimicry:
Same equipment (syringe, speculum) as intervention group. Identical patient positioning and timing
Local Anesthesia (Mepivacaine 3%)
Patients in this group will receive an injection of 3% mepivacaine into the uterosacral ligaments before undergoing diagnostic hysteroscopy. The anesthetic will be administered using a 25 mm Carpule needle, with 3.4 mL injected into each uterosacral ligament under standard gynecological positioning. The procedure will begin approximately one minute after administration to allow time for the anesthetic effect.
Intervention Type: Drug Drug Name: Mepivacaine 3% Dose and Route: Local injection - 6.8 mL total (3.4 mL per side) Purpose: To assess the effect of local anesthesia on pain perception during outpatient hysteroscopy.
Local paracervical Anesthesia
1\. Intervention Group (Local Anesthesia) Name: Mepivacaine 3% uterosacral ligament block Type: Pharmacological (local anesthetic).
Dose/Administration:
Drug: Mepivacaine hydrochloride 3% (4 vials of 1.7 mL each, total 6.8 mL). Route: Bilateral injection into uterosacral ligaments (2 injections per ligament, 3.4 mL per side).
Technique:
Patient in lithotomy position. Uterosacral ligaments identified posteriorly to the cervix. Injection with a 27G Carpule needle (25 mm length) at 2-3 mm depth. Slow infusion (to minimize dispersion). Timing: Administered ≥1 minute before hysteroscopy.
Interventions
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Local paracervical Anesthesia
1\. Intervention Group (Local Anesthesia) Name: Mepivacaine 3% uterosacral ligament block Type: Pharmacological (local anesthetic).
Dose/Administration:
Drug: Mepivacaine hydrochloride 3% (4 vials of 1.7 mL each, total 6.8 mL). Route: Bilateral injection into uterosacral ligaments (2 injections per ligament, 3.4 mL per side).
Technique:
Patient in lithotomy position. Uterosacral ligaments identified posteriorly to the cervix. Injection with a 27G Carpule needle (25 mm length) at 2-3 mm depth. Slow infusion (to minimize dispersion). Timing: Administered ≥1 minute before hysteroscopy.
Placebo
Procedure:
Vaginal and cervical irrigation with 0.9% saline solution (4 irrigations, mimicking anesthesia administration).
Mimicry:
Same equipment (syringe, speculum) as intervention group. Identical patient positioning and timing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Indication for office-based diagnostic hysteroscopy: The patient must be scheduled for a diagnostic hysteroscopy, either for uterine cavity evaluation or diagnostic purposes.
* Simple procedures like uterine polypectomies involving 1, 2, or more than 3 polyps or endometrial biopsy
* No previous hysteroscopies
Exclusion Criteria
* Known allergy to any local anesthetic
* General contraindications to hysteroscopy including pregnancy (established via interview, last menstrual period, contraceptive use, or pregnancy test), active infection (e.g., pyometra or recent pelvic inflammatory disease), recent uterine perforation, etc.
* Complex procedures like myomectomy with morcellator
* Failure to access the uterine cavity
* Anatomic conditions preventing cavity access
* Excessive procedure duration or fluid use (fluid deficit \> 1000 cc)
* Known uterine malformations
* Waiting times exceeding 60 minutes
* Use of analgesic medication prior to the procedure
* Major complications related to the procedure including uterine perforation, creation of a false passage, or significant bleeding requiring interventions beyond standard care.
* Incomplete delivery of informed consent or failure to complete the pre-procedure anxiety questionnaire.
18 Years
FEMALE
No
Sponsors
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Maimónides Biomedical Research Institute of Córdoba
OTHER
Responsible Party
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Paula Caballero
MD Obstetrics and Gynecology Reina Sofia Hospital
Principal Investigators
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Jorge Garcia Fernandez, MD, Principal Investigator
Role: PRINCIPAL_INVESTIGATOR
MD Obstetrics and Gynecology Reina Sofia Hospital, Cordoba, Spain
Central Contacts
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References
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Al-Sunaidi M, Tulandi T. A randomized trial comparing local intracervical and combined local and paracervical anesthesia in outpatient hysteroscopy. J Minim Invasive Gynecol. 2007 Mar-Apr;14(2):153-5. doi: 10.1016/j.jmig.2006.09.007.
Kokanali MK, Guzel AI, Ozer I, Topcu HO, Cavkaytar S, Doganay M. Pain experienced during and after office hysteroscopy with and without intracervical anesthesia. J Exp Ther Oncol. 2014;10(4):243-6.
Vercellini P, Colombo A, Mauro F, Oldani S, Bramante T, Crosignani PG. Paracervical anesthesia for outpatient hysteroscopy. Fertil Steril. 1994 Nov;62(5):1083-5.
Cooper NA, Khan KS, Clark TJ. Local anaesthesia for pain control during outpatient hysteroscopy: systematic review and meta-analysis. BMJ. 2010 Mar 23;340:c1130. doi: 10.1136/bmj.c1130.
Ahmad G, Saluja S, O'Flynn H, Sorrentino A, Leach D, Watson A. Pain relief for outpatient hysteroscopy. Cochrane Database Syst Rev. 2017 Oct 5;(10)(10):CD007710. doi: 10.1002/14651858.CD007710.pub3.
De Silva PM, Carnegy A, Smith PP, Clark TJ. Local anaesthesia for office hysteroscopy: A systematic review & meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2020 Sep;252:70-81. doi: 10.1016/j.ejogrb.2020.05.062. Epub 2020 Jun 2.
Huang L, Yu Q, Zhu Z, Huang P, Ding X, Ma X, Chen Y, Su D. The Current Situation of Anaesthesia for Hysteroscopy in Mainland China: A National Survey. J Pers Med. 2023 Sep 26;13(10):1436. doi: 10.3390/jpm13101436.
Nowak A, Chmaj-Wierzchowska K, Lach A, Malinger A, Wilczak M. Evaluation of Pain During Hysteroscopy Under Local Anesthesia, Including the Stages of the Procedure. J Clin Med. 2024 Nov 21;13(23):7030. doi: 10.3390/jcm13237030.
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Other Identifiers
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HARP
Identifier Type: -
Identifier Source: org_study_id
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