Paracervical Block Versus Transcervical Block in Outpatient Procedural Hysteroscopy

NCT05967936 | Unknown

• 1 other identifier: MP-12-2023-3238
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

Hysteroscopy is a minimally invasive, diagnostic and therapeutic gynecological surgical technique and the gold standard in the study of the uterine cavity. Thanks to the decrease in the diameter of hysteroscopes and to the vaginoscopic approach, anesthesia is no longer necessary in diagnostic hysteroscopy. Nevertheless, in operative hysteroscopy, given the instrumentalization and the need of cervical dilation, the use of local anesthesia, with or without sedation, is recommended. The different alternatives described in the literature are the following:

1. 1.Cervical/ intracervical block: injection of local anesthetic into the four quadrants of the cervix.
2. 2.Paracervical block: injection of local anesthetic in the cervicovaginal junction at 5 and 7 o'clock positions.
3. 3.Transcervical (uterine) anesthesia: instillation of a local anesthetic agent via catheter through the cervix and into the uterine cavity.
4. 4.Topical cervical anesthesia: application of local anesthetic in gel or spray to the cervix.

Conditions

Myoma;Uterus; Polyp Uterus

Keywords

hysteroscopy; pain; local anesthetic; ambulatory care; bupivacaine; paracervical block; transcervical block

Outcome Measures

Primary Outcomes (2)

• To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy

  comparing 10 point visual analogue scale (from 0 to 10 points) between two groups of patients recieving Bupivacaine administrated through a paracervical block versus a transcervical block

  during hysteroscopy

• To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy

  comparing 10 point visual analogue scale (from 0 to 10 points) between two groups of patients recieving Bupivacaine administrated through a paracervical block versus a transcervical block

  15 minutes post hysteroscopy

Secondary Outcomes (5)

• Compare the pain experience based on the visual analogue scale between pre and post-menopausal patients

  during hysteroscopy

• Compare the pain experience based on the visual analogue scale between pre and post-menopausal patients

  15 minutes post hysteroscopy

• Compare the pain experience based on the visual analogue scale between nulliparous and parous patients

  during hysteroscopy

• Compare the pain experience based on the visual analogue scale between nulliparous and parous patients

  15 minutes post hysteroscopy

• To evaluate the need for an extra intravenous sedative dose.

  during hysteroscopy

Study Arms (2)

Paracervical block

ACTIVE COMPARATOR

10cc Bupivacaine 1% at 0.5-1 cm depth of the cervicovaginal junction at 5 and 7 o'clock positions (20cc in total).

Drug: Bupivacaine Injection

Transcervical block

EXPERIMENTAL

10cc Bupivacaine 1% through the endocervix using an 17-gauge epidural catheter

Drug: Bupivacaine Injection

Interventions

Bupivacaine Injection DRUG

evaluation of pain by using two different types of local anesthesia

Also known as: evaluation of pain by using two different types of local anesthesia

Paracervical block; Transcervical block

Eligibility Criteria

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

You may qualify if:

• Female patients
• years of age or older
• Indication of outpatient surgical hysteroscopy for polypectomy and myomectomy

You may not qualify if:

• Women under 18 years old
• Unable to understand how to score a visual analog scale pain score
• Hysteroscopy contraindication
• Patients with medical history or current status that makes outpatient procedure usafe

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead
• Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal: collaborator

Study Sites (1)

CIUSSS de l'Est de l'Île de Montréal

Montreal East, Quebec, H1T 2M4, Canada

Location

Related Publications (14)

• Readman E, Maher PJ. Pain relief and outpatient hysteroscopy: a literature review. J Am Assoc Gynecol Laparosc. 2004 Aug;11(3):315-9. doi: 10.1016/s1074-3804(05)60042-4.

  PMID: 15559340 BACKGROUND

• Lau WC, Tam WH, Lo WK, Yuen PM. A randomised double-blind placebo-controlled trial of transcervical intrauterine local anaesthesia in outpatient hysteroscopy. BJOG. 2000 May;107(5):610-3. doi: 10.1111/j.1471-0528.2000.tb13301.x.

  PMID: 10826574 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

• Bettocchi S, Selvaggi L. A vaginoscopic approach to reduce the pain of office hysteroscopy. J Am Assoc Gynecol Laparosc. 1997 Feb;4(2):255-8. doi: 10.1016/s1074-3804(97)80019-9.

  PMID: 9050737 BACKGROUND

• Cicinelli E, Didonna T, Ambrosi G, Schonauer LM, Fiore G, Matteo MG. Topical anaesthesia for diagnostic hysteroscopy and endometrial biopsy in postmenopausal women: a randomised placebo-controlled double-blind study. Br J Obstet Gynaecol. 1997 Mar;104(3):316-9. doi: 10.1111/j.1471-0528.1997.tb11460.x.

  PMID: 9091008 BACKGROUND

• Lau WC, Lo WK, Tam WH, Yuen PM. Paracervical anaesthesia in outpatient hysteroscopy: a randomised double-blind placebo-controlled trial. Br J Obstet Gynaecol. 1999 Apr;106(4):356-9. doi: 10.1111/j.1471-0528.1999.tb08274.x.

  PMID: 10426243 BACKGROUND

• Zupi E, Luciano AA, Valli E, Marconi D, Maneschi F, Romanini C. The use of topical anesthesia in diagnostic hysteroscopy and endometrial biopsy. Fertil Steril. 1995 Feb;63(2):414-6.

  PMID: 7843454 BACKGROUND

• Broadbent JA, Hill NC, Molnar BG, Rolfe KJ, Magos AL. Randomized placebo controlled trial to assess the role of intracervical lignocaine in outpatient hysteroscopy. Br J Obstet Gynaecol. 1992 Sep;99(9):777-9. doi: 10.1111/j.1471-0528.1992.tb13886.x. No abstract available.

  PMID: 1420022 BACKGROUND

• 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 BACKGROUND

• Kosus N, Kosus A, Guler A, Simavli SA, Turhan NO. Transcervical intrauterine levobupivacaine infusion or paracervical block for pain control during endometrial biopsy. Exp Ther Med. 2012 Apr;3(4):683-688. doi: 10.3892/etm.2012.463. Epub 2012 Jan 30.

  PMID: 22969951 BACKGROUND

• Guida M, Pellicano M, Zullo F, Acunzo G, Lavitola G, Palomba S, Nappi C. Outpatient operative hysteroscopy with bipolar electrode: a prospective multicentre randomized study between local anaesthesia and conscious sedation. Hum Reprod. 2003 Apr;18(4):840-3. doi: 10.1093/humrep/deg075.

  PMID: 12660281 BACKGROUND

• Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

  PMID: 22588748 BACKGROUND

• Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.

  PMID: 3785962 BACKGROUND

• Chudnoff S, Einstein M, Levie M. Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):26-34. doi: 10.1097/AOG.0b013e3181c51ace.

  PMID: 20027030 BACKGROUND

MeSH Terms

Conditions

Myofibroma; Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Mélissa Roy, MD

  OB-GYN

  STUDY DIRECTOR

Central Study Contacts

Janey Fang, MD

CONTACT

5142513051; jfang85@uwo.ca

Chantal Rivard, MD

CONTACT

5142513051; rivardch@videotron.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentric, prospective, randomized trial, single-blinded, where eligible patients will be randomized to either receive paracervical or transcervical anesthesia before outpatient surgical hysteroscopy

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: August 1, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)