Brief Title
Paracervical Block in Laparoscopic Hysterectomy
Official Title
A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Paracervical Block Before Total Laparoscopic Hysterectomy for Postoperative Pain Control (PALAPA):
Brief Summary
It remains controversial whether paracervical block should be performed as a powerful strategy for pain relief in total laparoscopic hysterectomy (TLH), 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 TLHs for benign gynecologic conditions on postoperative pain relief.
Detailed Description
Postoperative pain management is an important component of patient care and satisfaction after surgery. Although contemporary changes such as a shift to minimally invasive approaches and an introduction of the enhanced recovery after surgery (ERAS) program have resulted in improved outcomes, a large number of patients undergoing surgery have still inadequate pain control. Paracervical block is a single-injection of anesthetic around the cervix at a depth of about 1 cm, diffusing anesthetic into the second to fourth sacral nerve roots passing through Frankenhäuser plexus. Moreover, recent randomized trials demonstrated that patients who underwent vaginal hysterectomy and received a paracervical block had lower postoperative pain in the first 3-6 hours compared with placebo. However, it remains controversial whether paracervical block should be performed as a powerful strategy for pain relief in total laparoscopic hysterectomy (TLH), 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 TLHs for benign gynecologic conditions on postoperative pain relief.
Study Type
Interventional
Primary Outcome
Postoperative pain
Secondary Outcome
Frequency of pills/injections requested
Condition
Uterine Fibroid
Intervention
Paracervical block
Study Arms / Comparison Groups
Paracervical block with 5% bupivacaine
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
86
Start Date
February 21, 2019
Completion Date
February 1, 2021
Primary Completion Date
February 1, 2021
Eligibility Criteria
Inclusion Criteria: - age between 18 and 65 years - 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 procedures (anterior or posterior colporrhaphy or mid-urethral slings), previously taking opioids for chronic pain - inability to accurately express their pain
Gender
Female
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Taejong Song, M.D., Ph.D., +821040358405, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT03792009
Organization ID
2019-01-001
Responsible Party
Principal Investigator
Study Sponsor
Kangbuk Samsung Hospital
Study Sponsor
Taejong Song, M.D., Ph.D., Principal Investigator, Kangbuk Samsung Hospital
Verification Date
February 2019