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

Kangbuk Samsung Hospital

Status: Unknown

Conditions: Uterine Fibroid

Treatments: Drug: 5% bupivacaine; Drug: Normal saline; Device: Paracervical block

Study type: Interventional

Funder types: Other

Identifiers

NCT04068766

KBSMC 2019-08-024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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62 participants in 2 patient groups, including a placebo group

Paracervical block with 5% bupivacaine

Experimental group

Description:

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.

Treatment:

Device: Paracervical block

Drug: 5% bupivacaine

Paracervical block with normal saline

Placebo Comparator group

Description:

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

Treatment:

Device: Paracervical block

Drug: Normal saline