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Anesthetics

Bupivacaine

Anesthetics, Local

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

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

evaluation of pain by using two different types of local anesthesia

Bupivacaine Injection

Janey Fang, MD

Chantal Rivard, MD

Paz Garcia, MD

Mélissa Roy, MD

Émilie Hudon, MD

Émilie Gorak, MD

Mik Gangal, MD

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.

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.

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

Paracervical Block Versus Transcervical Block in Outpatient Procedural Hysteroscopy

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

There is not a plan to make IPD available

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

Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between pre and post-menopausal patients

Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between nulliparous and parous patients

Number of patients who demand an extra dose of sedative during hysteroscopy

Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal

Ciusss de L'Est de l'Île de Montréal

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Pain, Postoperative

Adenomyosis

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Vasoconstrictor Agents

Respiratory System Agents

Epinephrine

Racepinephrine

Epinephryl borate

The paracervical injection with 10 mL of 0.5% bupivacaine plus 1:200,000 epinephrine was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.

The paracervical injection with 10 mL of normal saline was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.

The paracervical injection with 10 mL of 0.5% bupivacaine plus 1:200,000 epinephrine or normal saline was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.

Paracervical block

5% bupivacaine

Normal saline

Taejong Song, M.D., Ph.D.

Su Yaen Kim, M.D.

Taejong Song, MD PhD

Taejong Song, MD, PhD

San-Hui Lee, M.D.

It remains controversial whether paracervical block should be performed as a powerful strategy for pain relief in total laparoscopic hysterectomy (TLH), because convincing conclusions are difficult to draw because of the heterogeneous and contradictory nature of the literature. Therefore, the aim of this study was to evaluate the efficacy of paracervical blocks using with 0.5% bupivacaine prior to TLHs for benign gynecologic conditions on postoperative pain relief.

Postoperative pain management is an important component of patient care and satisfaction after surgery. Although contemporary changes such as a shift to minimally invasive approaches and an introduction of the enhanced recovery after surgery (ERAS) program have resulted in improved outcomes, a large number of patients undergoing surgery have still inadequate pain control. Paracervical block is a single-injection of anesthetic around the cervix at a depth of about 1 cm, diffusing anesthetic into the second to fourth sacral nerve roots passing through Frankenhäuser plexus. Moreover, recent randomized trials demonstrated that patients who underwent vaginal hysterectomy and received a paracervical block had lower postoperative pain in the first 3-6 hours compared with placebo.

However, it remains controversial whether paracervical block should be performed as a powerful strategy for pain relief in total laparoscopic hysterectomy (TLH), because convincing conclusions are difficult to draw because of the heterogeneous and contradictory nature of the literature. Therefore, the aim of this study was to evaluate the efficacy of paracervical blocks using with 0.5% bupivacaine prior to TLHs for benign gynecologic conditions on postoperative pain relief.

Paracervical Block in Laparoscopic Hysterectomy

A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Paracervical Block Before Total Laparoscopic Hysterectomy for Postoperative Pain Control (PALAPA):

The scale was presented as a 10-cm line with verbal descriptors ranging from "no pain" to "worst imaginable pain".

Narcotic and non-narcotic use were measured by number of pills/injections requested within 24-hour after surgery.

Kangbuk Samsung Hospital

Professor

ck with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.

Taejong Song

It remains controversial whether paracervical block should be performed as a powerful strategy for pain relief in laparoscopic myomectomy (LM), because convincing conclusions are difficult to draw because of the heterogeneous and contradictory nature of the literature. Therefore, the aim of this study was to evaluate the efficacy of paracervical blocks using with 0.5% bupivacaine prior to LM for benign gynecologic conditions on postoperative pain relief.

However, no study investigating the efficacy of paracervical block in laparoscopic myomectomy on postoperative pain was conducted, to date. Therefore, the goal of this study is to evaluate whether patients who receive a paracervical block of 5% bupivacaine with epinephrine at the time of laparoscopic myomectomy would have lower postoperative pain, with less consumption of rescue analgesics than patients who receive a paracervical block of normal saline.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Paracervical Block Versus Transcervical Block in Outpatient Procedural Hysteroscopy	NCT05967936	Myoma;Uterus Polyp Uterus	Bupivacaine Inj...	18 Years -	Ciusss de L'Est de l'Île de Montréal
Paracervical Block in Laparoscopic Hysterectomy	NCT03792009	Uterine Fibroid Adenomyosis	Paracervical bl... 5% bupivacaine Normal saline	18 Years - 65 Years	Kangbuk Samsung Hospital
Efficacy of Paracervical Block in Laparoscopic Myomectomy: a Randomized Controlled Trial (PALM)	NCT04068766	Uterine Fibroid	Paracervical bl... 5% bupivacaine Normal saline	18 Years - 60 Years	Kangbuk Samsung Hospital
Paracervical Block Versus Transcervical Block in Outpatient Procedural Hysteroscopy	NCT05967936	Myoma;Uterus Polyp Uterus	Bupivacaine Inj...	18 Years -	Ciusss de L'Est de l'Île de Montréal

Spots Global Cancer Trial Database for paracervical block