Paracervical Block in Laparoscopic Hysterectomy
PALAPA
A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Paracervical Block Before Total Laparoscopic Hysterectomy for Postoperative Pain Control (PALAPA):
1 other identifier
interventional
86
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2019
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 28, 2018
CompletedFirst Posted
Study publicly available on registry
January 3, 2019
CompletedStudy Start
First participant enrolled
February 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedFebruary 25, 2019
February 1, 2019
1.9 years
December 28, 2018
February 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative pain
The scale was presented as a 10-cm line with verbal descriptors ranging from "no pain" to "worst imaginable pain".
at 6-hour after surgery
Secondary Outcomes (1)
Frequency of pills/injections requested
Within 24-hour after surgery
Study Arms (2)
Paracervical block with 5% bupivacaine
EXPERIMENTALThe 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
PLACEBO COMPARATORThe 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Samsung Medical Center
Seoul, 03181, South Korea
Kangbuk Samsung Hospital
Seoul, 110-746, South Korea
Wonju Severance Christian Hospital
Wŏnju, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Taejong Song, M.D., Ph.D.
Kangbuk Samsung Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 28, 2018
First Posted
January 3, 2019
Study Start
February 21, 2019
Primary Completion
February 1, 2021
Study Completion
February 1, 2021
Last Updated
February 25, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share