Pericervical Analgesia Versus Analesia With Nitrous Oxide (N2O) in Outpatien Operative Hysteroscopy With Miniresector

NCT06092541 | Completed

• 1 other identifier: CE 130/2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This research will have the aim of evaluating and comparing the effectiveness of two methods (analgesia with nitrous oxide and pericervical analgesia, excluding the use of paracervical block due to the increased risk of complications reported in the literature in the control of pain caused during Outpatient Operative Hysteroscopy maneuvers with Miniresector.

Conditions

Hysteroscopy

Keywords

hysteroscopy; pain control; pericervical anesthesia; nitrous oxide

Outcome Measures

Primary Outcomes (1)

• Rate of pain, measured through the Visual Analog Scale 1 (no pain) to 10 (worse pain) using Pericervical Analgesia versus Analgesia with Nitrous Oxide in outpatient hysteroscopic surgery with Miniresector

  Change From Baseline in Pain Scores on the Visual Analog Scale -VAS- using Pericervical Analgesia versus Analgesia with Nitrous Oxide in outpatient hysteroscopic surgery with Miniresector

  6 months

Study Arms (2)

Intervention group: pericervical anesthesia

EXPERIMENTAL

Intervention group: pericervical anesthesia

Drug: Intervention Group: pericervical anesthesia

Control group: nitrous oxide anesthesia

ACTIVE COMPARATOR

Control group: nitrous oxide anesthesia

Other: Nitroux Oxide anesthesia

Interventions

Intervention Group: pericervical anesthesia DRUG

Patients assigned to the Intervention Group will receive Pericervical anesthesia before performing Hysteroscopy. Specifically, for the administration of pericervical analgesia, Mepivacaine/Lidocaine 1.5% 10/15 ml (max dose 7 mg/kg) will be used and pericervical infiltration will be performed at 0.5 cm depth at 3 and 9 hours.

Also known as: Pericervical Anesthesia

Intervention group: pericervical anesthesia

Nitroux Oxide anesthesia OTHER

Patients assigned to the Control Group will receive Nitrous Oxide anesthesia before hysteroscopy

Also known as: N2O2 Anesthesia

Control group: nitrous oxide anesthesia

Eligibility Criteria

• Age: 25 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• nulliparous or primiparous women (a previous Spontaneous Vaginal Birth -PS- or a previous Cesarean Section -TC- the latter comparable to nulliparous women as no previous cervical dilation -)
• age between 25 and 50 years

You may not qualify if:

• age \< 25 or \> 50 years
• multiparity
• positive history of previous operations on the cervical canal (e.g. conization)

Sponsors & Collaborators

• Ospedale degli Infermi di Biella: lead

Study Sites (1)

Ospedale degli Infermi

Biella, Italy

Location

Related Publications (15)

• Dealberti D, Riboni F, Prigione S, Pisani C, Rovetta E, Montella F, Garuti G. New mini-resectoscope: analysis of preliminary quality results in outpatient hysteroscopic polypectomy. Arch Gynecol Obstet. 2013 Aug;288(2):349-53. doi: 10.1007/s00404-013-2754-7. Epub 2013 Feb 16.

  PMID: 23417150 BACKGROUND

• 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 BACKGROUND

• Meyer L, Moore J, McMillan L. Outpatient Hysteroscopy in the Management of Abnormal Vaginal Bleeding. J Am Assoc Gynecol Laparosc. 1996 Aug;3(4, Supplement):S30-1. doi: 10.1016/s1074-3804(96)80239-8.

  PMID: 9074183 BACKGROUND

• Zupi E, Luciano AA, Marconi D, Valli E, Patrizi G, Romanini C. The use of topical anesthesia in diagnostic hysteroscopy and endometrial biopsy. J Am Assoc Gynecol Laparosc. 1994 May;1(3):249-52. doi: 10.1016/s1074-3804(05)81018-7.

  PMID: 9050495 BACKGROUND

• Solano Calvo JA, Del Valle Rubido C, Rodriguez-Miguel A, de Abajo FJ, Delgado Espeja JJ, Gonzalez Hinojosa J, Fernandez Munoz L, Zapico Goni A. Nitrous oxide versus lidocaine versus no analgesic for in-office hysteroscopy: a randomised clinical trial. BJOG. 2021 Jul;128(8):1364-1372. doi: 10.1111/1471-0528.16657. Epub 2021 Mar 9.

  PMID: 33528862 BACKGROUND

• Del Valle Rubido C, Solano Calvo JA, Rodriguez Miguel A, Delgado Espeja JJ, Gonzalez Hinojosa J, Zapico Goni A. Inhalation analgesia with nitrous oxide versus other analgesic techniques in hysteroscopic polypectomy: a pilot study. J Minim Invasive Gynecol. 2015 May-Jun;22(4):595-600. doi: 10.1016/j.jmig.2015.01.005. Epub 2015 Jan 14.

  PMID: 25596171 BACKGROUND

• De Silva PM, Carnegy A, Graham C, Smith PP, Clark TJ. Conscious sedation for office hysteroscopy: A systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2021 Nov;266:89-98. doi: 10.1016/j.ejogrb.2021.09.001. Epub 2021 Sep 3.

  PMID: 34600190 BACKGROUND

• Vitale SG, Alonso Pacheco L, Haimovich S, Riemma G, De Angelis MC, Carugno J, Lasmar RB, Di Spiezio Sardo A. Pain management for in-office hysteroscopy. A practical decalogue for the operator. J Gynecol Obstet Hum Reprod. 2021 Jan;50(1):101976. doi: 10.1016/j.jogoh.2020.101976. Epub 2020 Nov 6.

  PMID: 33166706 BACKGROUND

• De Silva PM, Mahmud A, Smith PP, Clark TJ. Analgesia for Office Hysteroscopy: A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 2020 Jul-Aug;27(5):1034-1047. doi: 10.1016/j.jmig.2020.01.008. Epub 2020 Jan 23.

  PMID: 31982584 BACKGROUND

• Schneider EN, Riley R, Espey E, Mishra SI, Singh RH. Nitrous oxide for pain management during in-office hysteroscopic sterilization: a randomized controlled trial. Contraception. 2017 Mar;95(3):239-244. doi: 10.1016/j.contraception.2016.09.006. Epub 2016 Sep 9.

  PMID: 27621048 BACKGROUND

• Munro MG, Brooks PG. Use of local anesthesia for office diagnostic and operative hysteroscopy. J Minim Invasive Gynecol. 2010 Nov-Dec;17(6):709-18. doi: 10.1016/j.jmig.2010.07.009.

  PMID: 20955982 BACKGROUND

• Keyhan S, Munro MG. Office diagnostic and operative hysteroscopy using local anesthesia only: an analysis of patient reported pain and other procedural outcomes. J Minim Invasive Gynecol. 2014 Sep-Oct;21(5):791-8. doi: 10.1016/j.jmig.2014.03.006. Epub 2014 Mar 25.

  PMID: 24681061 BACKGROUND

• De Iaco P, Marabini A, Stefanetti M, Del Vecchio C, Bovicelli L. Acceptability and pain of outpatient hysteroscopy. J Am Assoc Gynecol Laparosc. 2000 Feb;7(1):71-5. doi: 10.1016/s1074-3804(00)80012-2.

  PMID: 10648742 BACKGROUND

• The Use of Hysteroscopy for the Diagnosis and Treatment of Intrauterine Pathology: ACOG Committee Opinion, Number 800. Obstet Gynecol. 2020 Mar;135(3):e138-e148. doi: 10.1097/AOG.0000000000003712.

  PMID: 32080054 BACKGROUND

• Ahlbom A. Modern Epidemiology, 4th edition. TL Lash, TJ VanderWeele, S Haneuse, KJ Rothman. Wolters Kluwer, 2021. Eur J Epidemiol. 2021 Aug;36(8):767-768. doi: 10.1007/s10654-021-00778-w. Epub 2021 Jul 3. No abstract available.

  PMID: 34216355 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

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

Study Officials

• Bianca Masturzo, MD PhD

  Ospedale degli Infermi Biella

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patients, in the database, will be identified as group A and B; Once the study and the compilation of the database have been completed, this will be delivered to the results evaluation team which will therefore be blinded, not being able to recognize whether group A and B belong to control or intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Obstetrics and Gynecology

Model Details: Single-blind, randomized clinical pilot study with masked third-party assessment. Patients will be assigned to the two groups (pericervical analgesia / nitrous oxide) through the sealed envelope method.

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 23, 2023
• Study Start: October 2, 2023
• Primary Completion: May 2, 2024
• Study Completion: May 2, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: At the end of the study, for 6 months from the 1st may 2024 to 1st November 2024
• Access Criteria: Participants centers

Locations

IT (1)