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Efficacy of Paracervical Block in Laparoscopic Myomectomy: a Randomized Controlled Trial (PALM) (PALM)

Primary Purpose

Uterine Fibroid

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Paracervical block
5% bupivacaine
Normal saline
Sponsored by
Kangbuk Samsung Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroid

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kangbuk Samsung HospitalRecruiting
  • Wonju Severance Christian HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Paracervical block with 5% bupivacaine

Paracervical block with normal saline

Arm 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.

ck with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.

Outcomes

Primary Outcome Measures

Postoperative pain
The scale was presented as a 10-cm line with verbal descriptors ranging from "no pain" to "worst imaginable pain".

Secondary Outcome Measures

Frequency of pills/injections requested
Narcotic and non-narcotic use were measured by number of pills/injections requested within 24-hour after surgery.

Full Information

First Posted
August 23, 2019
Last Updated
August 23, 2019
Sponsor
Kangbuk Samsung Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04068766
Brief Title
Efficacy of Paracervical Block in Laparoscopic Myomectomy: a Randomized Controlled Trial (PALM)
Acronym
PALM
Official Title
Efficacy of Paracervical Block in Laparoscopic Myomectomy: a Randomized Controlled Trial (PALM)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 23, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
August 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kangbuk Samsung Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paracervical block with 5% bupivacaine
Arm Type
Experimental
Arm 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.
Arm Title
Paracervical block with normal saline
Arm Type
Placebo Comparator
Arm Description
ck with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.
Intervention Type
Device
Intervention Name(s)
Paracervical block
Other Intervention Name(s)
Experimental arm, Control arm
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
5% bupivacaine
Other Intervention Name(s)
Experimental arm
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Control arm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative pain
Description
The scale was presented as a 10-cm line with verbal descriptors ranging from "no pain" to "worst imaginable pain".
Time Frame
at 6-hour after surgery
Secondary Outcome Measure Information:
Title
Frequency of pills/injections requested
Description
Narcotic and non-narcotic use were measured by number of pills/injections requested within 24-hour after surgery.
Time Frame
Within 24-hour after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taejong Song, MD PhD
Phone
+821040358405
Email
taejong.song@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taejong Song
Organizational Affiliation
Kangbuk Samsung Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taejong Song
Phone
1040358405
Email
taejong.song@gmail.com
Facility Name
Wonju Severance Christian Hospital
City
Wonju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
San-Hui Lee, M.D.
Phone
+821040358405
Email
saniarami@gmail.com
First Name & Middle Initial & Last Name & Degree
San-Hui Lee, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Paracervical Block in Laparoscopic Myomectomy: a Randomized Controlled Trial (PALM)

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