Status:
UNKNOWN
Efficacy of Paracervical Block in Laparoscopic Myomectomy: a Randomized Controlled Trial (PALM)
Lead Sponsor:
Kangbuk Samsung Hospital
Conditions:
Uterine Fibroid
Eligibility:
FEMALE
18-60 years
Phase:
NA
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 bec...
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 pat...
Eligibility Criteria
Inclusion
- Uterine myoma
- American Society of Anesthesiologists physical status (ASAPS) classification I-II
- The absence of pregnancy at the time of surgery.
Exclusion
- 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
Key Trial Info
Start Date :
August 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04068766
Start Date
August 23 2019
End Date
August 1 2020
Last Update
August 28 2019
Active Locations (2)
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1
Kangbuk Samsung Hospital
Seoul, South Korea, 03181
2
Wonju Severance Christian Hospital
Wŏnju, South Korea