NCT04068766

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Kangbuk Samsung Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2019-08-23
• Primary completion: 2020-08-01
• Completion: 2020-08-01
• First posted: 2019-08-28
• Last updated: 2019-08-28

Locations

2 sites across 1 country: South Korea