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

NCT04068766 | Unknown

• 1 other identifier: KBSMC 2019-08-024
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Uterine Fibroid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Frequency of pills/injections requested

  Within 24-hour after surgery

Study Arms (2)

Paracervical block with 5% bupivacaine

EXPERIMENTAL

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; Drug: 5% bupivacaine

Paracervical block with normal saline

PLACEBO COMPARATOR

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

Device: Paracervical block; Drug: Normal saline

Interventions

Paracervical block DEVICE

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.

Also known as: Experimental arm, Control arm

Paracervical block with 5% bupivacaine; Paracervical block with normal saline

5% bupivacaine DRUG

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.

Also known as: Experimental arm

Paracervical block with 5% bupivacaine

Normal saline DRUG

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.

Also known as: Control arm

Paracervical block with normal saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Uterine myoma
• American Society of Anesthesiologists physical status (ASAPS) classification I-II
• The absence of pregnancy at the time of surgery.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead

Study Sites (2)

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

RECRUITING

Wonju Severance Christian Hospital

Wŏnju, South Korea

RECRUITING

MeSH Terms

Conditions

Leiomyoma

Interventions

Anesthesia, Obstetrical; Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Taejong Song

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taejong Song, MD PhD

CONTACT

+821040358405; taejong.song@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: August 23, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)