Efficacy of Paracervical Block in Laparoscopic Myomectomy: a Randomized Controlled Trial (PALM)
- Conditions
- Uterine Fibroid
- Interventions
- Registration Number
- NCT04068766
- Lead Sponsor
- Kangbuk Samsung Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 62
- Uterine myoma
- American Society of Anesthesiologists physical status (ASAPS) classification I-II
- The absence of pregnancy at the time of surgery.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paracervical block with normal saline Paracervical block ck with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix. Paracervical block with 5% bupivacaine 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. Paracervical block with normal saline Normal saline ck with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix. Paracervical block with 5% bupivacaine Paracervical block 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.
- Primary Outcome Measures
Name Time Method Postoperative pain at 6-hour after surgery The scale was presented as a 10-cm line with verbal descriptors ranging from "no pain" to "worst imaginable pain".
- Secondary Outcome Measures
Name Time Method Frequency of pills/injections requested Within 24-hour after surgery Narcotic and non-narcotic use were measured by number of pills/injections requested within 24-hour after surgery.
Trial Locations
- Locations (2)
Wonju Severance Christian Hospital
🇰🇷Wonju, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of