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

K

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

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

Trial contacts and locations

2

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Central trial contact

Taejong Song, MD PhD

Data sourced from clinicaltrials.gov

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