Paracervical Block Versus Transcervical Block in Outpatient Procedural Hysteroscopy

Myoma;Uterus Clinical Trial

Official title:

A Prospective Randomized Study Comparing Different Types of Local Anesthesia in Outpatient Procedural Hysteroscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05967936
• Other study ID #: MP-12-2023-3238
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: June 2023
• Source: Ciusss de L'Est de l'Île de Montréal
• Contact: Janey Fang, MD
• Phone: 5142513051
• Email: jfang85[@]uwo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. Cervical/ intracervical block: injection of local anesthetic into the four quadrants of the cervix.

2. Paracervical block: injection of local anesthetic in the cervicovaginal junction at 5 and 7 o'clock positions.

3. Transcervical (uterine) anesthesia: instillation of a local anesthetic agent via catheter through the cervix and into the uterine cavity.

4. Topical cervical anesthesia: application of local anesthetic in gel or spray to the cervix.

To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy, the investigators will perform a prospective multicentric study that compare two types of local anesthesia in outpatient procedural hysteroscopy: paracervical block, that is the actual gold-standard, and transcervical instillation.

Description:

To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy, the investigators will perform a multicentric prospective randomized trial, single-blinded, that compares two types of local anesthesia in outpatient procedural hysteroscopy: paracervical block, that is the actual gold-standard, and transcervical instillation.

The population studied will consist in adult women with indication of an outpatient surgical hysteroscopy (myomectomy or polypectomy). Every one of them will be invited to participate the day of their procedure. In the outpatient hysteroscopy clinic, the investigators will verify inclusion and exclusion criteria, explain the objectives of the study, collect data and obtain the patient's consent.

The sample size is 242 patients (121 in each group). The study will be performed in two different centers:

• Integrated University Health Center and Social Services of the East of the Island of Montreal

• Integrated University Health Center and social services of the South Center of the Island of Montreal

Right before each procedure the patients will be randomized through anonymous and alternized enveloppes that will be distributed in each center, to either receive paracervical or transcervical anesthesia before hysteroscopy.

Each patient will receive a pre-established dose of sedative before the procedure, according to their weight: Fentanyl 0,5 mcg/kg IV and Midazolam 0,02 mg/kg. The subsequent doses will be noted.

Under sedation, with the patient in lithotomy position, a medium size speculum will be inserted. The vagina will be disinfected with chlorhexidine and the anterior lip of the cervix will be gripped with a Pozzi forceps.

According to previous randomization, each patient will receive one of the following alternatives of local anesthesia:

• Group A: Paracervical 10cc Bupivacaine 1%, without epinephrine, at 0.5-1 cm depth of the cervicovaginal junction at 5 and 7 o'clock positions (20cc in total).

• Group B: Transcervical (uterine) 10cc Bupivacaine 1% through the endocervix using an 17-Gauge epidural catheter

During the procedure (T1), the nurse will be in charge to fill the scale (to avoid bias). The patients will be given a Visual Analogue Scale (VAS) to fill 15 minutes after the procedure (before discharge), to assess pain.

For each group the investigators will calculate the average rate of pain according to the Visual Analogue Scale during and immediately after the procedure (15 minutes). The investigators will subdivide each group into pre and postmenopausal women and into nulliparous and parous women and compare their Visual Analogue Scale as well.

Statistical analysis will be performed to compare results.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 242
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female patients

• 18 years of age or older

• Indication of outpatient surgical hysteroscopy for polypectomy and myomectomy

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Leiomyoma
• Myoma;Uterus
• Polyp Uterus

Intervention

Drug:
• Bupivacaine Injection
evaluation of pain by using two different types of local anesthesia

Locations

Country	Name	City	State
Canada	CIUSSS de l'Est de l'Île de Montréal	Montréal-Est	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Ciusss de L'Est de l'Île de Montréal	Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal

Country where clinical trial is conducted

Canada, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Compare the pain experience based on the visual analogue scale between pre and post-menopausal patients	Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between pre and post-menopausal patients	during hysteroscopy
Secondary	Compare the pain experience based on the visual analogue scale between pre and post-menopausal patients	Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between pre and post-menopausal patients	15 minutes post hysteroscopy
Secondary	Compare the pain experience based on the visual analogue scale between nulliparous and parous patients	Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between nulliparous and parous patients	during hysteroscopy
Secondary	Compare the pain experience based on the visual analogue scale between nulliparous and parous patients	Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between nulliparous and parous patients	15 minutes post hysteroscopy
Secondary	To evaluate the need for an extra intravenous sedative dose.	Number of patients who demand an extra dose of sedative during hysteroscopy	during hysteroscopy