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

Uterine Fibroid Clinical Trial

— PALM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04068766
• Other study ID #: KBSMC 2019-08-024
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2019
• Source: Kangbuk Samsung Hospital
• Contact: Taejong Song, MD PhD
• Phone: +821040358405
• Email: taejong.song[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroid

Intervention

Device:
• Paracervical block
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.

Drug:
• 5% bupivacaine
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 saline
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.

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Wonju Severance Christian Hospital	Wonju

Sponsors (1)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	The scale was presented as a 10-cm line with verbal descriptors ranging from "no pain" to "worst imaginable pain".	at 6-hour after surgery
Secondary	Frequency of pills/injections requested	Narcotic and non-narcotic use were measured by number of pills/injections requested within 24-hour after surgery.	Within 24-hour after surgery