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

NCT ID: NCT04068766

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-23
• Study Completion Date: 2020-08-01

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.

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.

Conditions

Uterine Fibroid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Paracervical block

Intervention Type: 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.

5% bupivacaine

Intervention Type: 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.

Paracervical block with normal saline

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

Group Type: PLACEBO_COMPARATOR

Paracervical block

Intervention Type: 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.

Normal saline

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Experimental arm; Control arm; Experimental arm; Control arm

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kangbuk Samsung Hospital

OTHER

Sponsor Role: lead

Responsible Party

Taejong Song

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Taejong Song

Role: PRINCIPAL_INVESTIGATOR

Kangbuk Samsung Hospital

Locations

Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status: RECRUITING

Wonju Severance Christian Hospital

Wŏnju, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Taejong Song, MD PhD

Role: CONTACT

taejong.song@gmail.com

+821040358405

Facility Contacts

Taejong Song

Role: primary

taejong.song@gmail.com

1040358405

San-Hui Lee, M.D.

Role: primary

saniarami@gmail.com

+821040358405

Other Identifiers

KBSMC 2019-08-024

Identifier Type: -

Identifier Source: org_study_id