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

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.

Study Overview

• Status: Unknown
• Conditions: Uterine Fibroid
• Intervention / Treatment: Device: Paracervical block; Drug: 5% bupivacaine; Drug: Normal saline

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03181
    • Recruiting
    • Kangbuk Samsung Hospital
  • Wonju, Korea, Republic of
    • Recruiting
    • WonJu Severance Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Paracervical block with 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.	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.; Other Names: Control arm; Experimental arm; 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.; Other Names: Experimental arm
PLACEBO_COMPARATOR: Paracervical block with normal saline; ck with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.	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.; Other Names: Control arm; Experimental arm; Drug: 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.; Other Names: Control arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kangbuk Samsung Hospital
• Investigators: Principal Investigator: Taejong Song, Kangbuk Samsung Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 23, 2019
• Primary Completion (ANTICIPATED): August 1, 2020
• Study Completion (ANTICIPATED): August 1, 2020

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (ACTUAL): August 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 23, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Muscle Tissue; Leiomyoma; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: KBSMC 2019-08-024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No