Efficacy of Paracervical Block in Laparoscopic Myomectomy: a Randomized Controlled Trial (PALM)

Kangbuk Samsung Hospital62 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Uterine Fibroid

Interventions

Paracervical blockDEVICE

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.

5% bupivacaineDRUG

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.

Normal salineDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Uterine myoma * American Society of Anesthesiologists physical status (ASAPS) classification I-II * The absence of pregnancy at the time of surgery. Exclusion Criteria: * history of cervical surgery such as conization or cerclage * inability to perform the paracervical block due to anatomical abnormalities (i.e., very atrophic or small cervix) * allergy to bupivacaine, planned concomitant surgical procedures involving extensive additional tissue manipulation such as pelvic lymph node dissection * any concomitant surgery of pelvic floor repair (uterosacral ligament suspension or sacrocolpopexy) or vaginal procedure (anterior or posterior colporrhaphy or mid-urethral slings) * previously taking opioids for chronic pain * inability to accurately express their pain

Locations (2)

Kangbuk Samsung Hospital

Seoul, South Korea

RECRUITING

Wonju Severance Christian Hospital

Wŏnju, South Korea

RECRUITING

Outcomes

Primary Outcomes

Postoperative pain

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

Time frame: at 6-hour after surgery

Secondary Outcomes

Frequency of pills/injections requested

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

Time frame: Within 24-hour after surgery

Central Contacts

Taejong Song, MD PhD

CONTACT

+821040358405 taejong.song@gmail.com

Data from ClinicalTrials.gov

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