Uterine Fibroid
Conditions
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.
Interventions
DEVICEParacervical 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.
DRUG5% 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.
DRUGNormal 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.
Sponsors
Kangbuk Samsung Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Contacts
Primary ContactTaejong Song, MD PhD
Outcome results
None listed