Hysteroscopy Anesthesia for Relief of Pain

NCT07178379 | Not Yet Recruiting

• 1 other identifier: HARP
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized clinical trial aims to evaluate the effect of local anesthesia on pain perception in patients undergoing outpatient diagnostic hysteroscopy. Although generally well tolerated, pain during hysteroscopy remains a leading cause of procedural failure and patient discomfort. Current evidence on the effectiveness of local anesthetic techniques is limited, with considerable variability in study designs, patient populations, and outcomes measured. 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.

Conditions

Pain Management; Outpatient Hysteroscopy; Local Anesthesia; Procedural Pain Relief; Gynecologic Procedure

Keywords

hysteroscoy; outpatient hysteroscopy; pain assessment; visual analog scale; localanesthesia; ambulatory surgery; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Pain intensity during hysteroscopy

  Pain will be measured using a 10-point Visual Analog Scale (VAS) immediately after the procedure. Patients will be asked to rate the maximum pain experienced during the hysteroscopy. Measure Type: Continuous (VAS score 0-10) Unit of Measure: Points on VAS scale Method of Aggregation: Mean (± SD) Statistical Analysis Plan: Comparison between groups using Student's t-test or Mann-Whitney U test depending on normality.

  Immediately after the procedure

Secondary Outcomes (3)

• Need for post-procedure analgesia

  Within 30 minutes post-procedure

• Procedure-related complications

  During and immediately after the procedure

• Indication for surgical hysteroscopy due to intolerable pain

  Immediately post-procedure

Study Arms (2)

Control

PLACEBO COMPARATOR

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.

Other: Placebo

Local Anesthesia (Mepivacaine 3%)

EXPERIMENTAL

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.

Procedure: Local paracervical Anesthesia

Interventions

Local paracervical Anesthesia PROCEDURE

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.

Also known as: local anesthesia, mepivacaine, Mepivacaine 3% uterosacral ligament block

Local Anesthesia (Mepivacaine 3%)

Placebo OTHER

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

Also known as: Saline irrigation (sham procedure), Non-pharmacological

Control

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years: To ensure that participants are legal adults and able to provide informed consent.
• 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

You may not qualify if:

• Age \< 18 years
• 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.

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Related Publications (8)

• 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.

  PMID: 17368248 RESULT

• 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.

  PMID: 25509976 RESULT

• 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.

  PMID: 7646610 RESULT

• 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.

  PMID: 20332307 RESULT

• 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.

  PMID: 35611933 RESULT

• 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.

  PMID: 32570188 RESULT

• 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.

  PMID: 37888047 RESULT

• 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.

  PMID: 39685488 RESULT

MeSH Terms

Conditions

Agnosia

Interventions

Anesthesia, Local; Mepivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jorge Garcia Fernandez, MD, Principal Investigator

  MD Obstetrics and Gynecology Reina Sofia Hospital, Cordoba, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge Garcia Fernandez, MD, Principal Investigator

CONTACT

+34 622595644; jorgarciafernan@gmail.com

Paula Caballero, MD, Collaborator, Investigator

CONTACT

+34 617798032; paulacaballero.r@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a single-blind study with partial masking. Patients will not be explicitly informed whether they are receiving local anesthesia or placebo. In the control group, a simulated intervention (saline irrigation of the cervix and vagina) will be performed to mimic the anesthetic procedure. However, due to the nature of the intervention (injection of anesthetic vs. no injection), full blinding of patients is not feasible. 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Obstetrics and Gynecology Reina Sofia Hospital

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: September 17, 2025
• Study Start: September 6, 2025
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE