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The Visceral Analgesic Effect of Erector Spinae Plane Block in Laparoscopic Cholecystectomy

Primary Purpose

Visceral Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ultrasound guided Rectus sheath block
Ultrasound erector spinae plane block
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Visceral Pain, Postoperative focused on measuring laparoscopic cholecystectomy, erector spinae plane block, visceral pain

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. adults between the ages of 20 and 80
  2. scheduled laparoscopic cholecystectomy patient
  3. American society of anesthesiologists score 1 or 2
  4. Patients who have voluntarily agreed in writing to participate in the trial

Exclusion Criteria:

  1. Patient with side effects on local anesthetics or steroids
  2. Patient who are taboo of peripheral nerve block such as blood clotting disorder, infection, etc.
  3. Patients with uncontrolled medical or psychiatric problem
  4. Patient does not agree to participate in the study
  5. Patients with deformity at vertebra or chest wall.
  6. Patients who are pregnant or lactating
  7. Patients receiving a single laparoscopic cholecystectomy (including using a robot)
  8. Patients with severe intraperitoneal adhesion (higher than Nair s grade 3), or with external drain.

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group R : Rectus sheath block group

Group RE: Rectus sheath block and erector spinae plane block

Arm Description

ultrasound guided Rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml before surgical incision

ultrasound guided Rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml before surgical incision and ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml

Outcomes

Primary Outcome Measures

Difference of analgesic consumption between both group
The difference in analgesics usage between the two groups after the operation is checked at fixed intervals (at 0, 0.5, 1, 2, 6, 12, 18, 24 hours after operation) to compare.

Secondary Outcome Measures

compare the Numeric rating scale (NRS)
10 years old or older. 0: No pain, 1-3: mild pain, 4-6: Moderate pain, 7-10: severe pain, 10: worst pain imaginable. After surgery, the NRS differences between the two groups were compared at a constant interval (0, 0.5, 1, 2, 6, 12, 18, 24 hours postoperatively).

Full Information

First Posted
November 15, 2018
Last Updated
July 1, 2019
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03767816
Brief Title
The Visceral Analgesic Effect of Erector Spinae Plane Block in Laparoscopic Cholecystectomy
Official Title
The Visceral Analgesic Effect of Erector Spinae Plane Block in Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 17, 2018 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study was to investigate the effectiveness of erector spinae plane block on postoperative visceral pain in laparoscopic cholecystectomy (LLC). Given that rectus sheath block may provide sufficient somatic pain block, investigators aimed to investigate whether erector spinae block is effective in visceral pain block. After induction of general anesthesia, group of patient is decided randomly. In Group R, rectus sheath block is performed with 0.2% Ropivacaine 30ml before the operation. In Group RE, rectus sheath block and erector spinae plane block are performed with 0.2% ropivacaine 70ml before the operation. NRS score measurement and comparison of the rescue analgesic dose used at 0, 0.5, 1, 2,6, 12, 18, and 24 hours after arrival at the recovery room were collected

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visceral Pain, Postoperative
Keywords
laparoscopic cholecystectomy, erector spinae plane block, visceral pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group R : Rectus sheath block group
Arm Type
Experimental
Arm Description
ultrasound guided Rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml before surgical incision
Arm Title
Group RE: Rectus sheath block and erector spinae plane block
Arm Type
Active Comparator
Arm Description
ultrasound guided Rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml before surgical incision and ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml
Intervention Type
Drug
Intervention Name(s)
Ultrasound guided Rectus sheath block
Intervention Description
Ultrasound guided rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml around umbilicus
Intervention Type
Drug
Intervention Name(s)
Ultrasound erector spinae plane block
Intervention Description
Ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml at T7 level
Primary Outcome Measure Information:
Title
Difference of analgesic consumption between both group
Description
The difference in analgesics usage between the two groups after the operation is checked at fixed intervals (at 0, 0.5, 1, 2, 6, 12, 18, 24 hours after operation) to compare.
Time Frame
at 0, 0.5, 1, 2, 6, 12, 18, 24 hours after operation
Secondary Outcome Measure Information:
Title
compare the Numeric rating scale (NRS)
Description
10 years old or older. 0: No pain, 1-3: mild pain, 4-6: Moderate pain, 7-10: severe pain, 10: worst pain imaginable. After surgery, the NRS differences between the two groups were compared at a constant interval (0, 0.5, 1, 2, 6, 12, 18, 24 hours postoperatively).
Time Frame
at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adults between the ages of 20 and 80 scheduled laparoscopic cholecystectomy patient American society of anesthesiologists score 1 or 2 Patients who have voluntarily agreed in writing to participate in the trial Exclusion Criteria: Patient with side effects on local anesthetics or steroids Patient who are taboo of peripheral nerve block such as blood clotting disorder, infection, etc. Patients with uncontrolled medical or psychiatric problem Patient does not agree to participate in the study Patients with deformity at vertebra or chest wall. Patients who are pregnant or lactating Patients receiving a single laparoscopic cholecystectomy (including using a robot) Patients with severe intraperitoneal adhesion (higher than Nair s grade 3), or with external drain.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JongHyuk Lee, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
05505
Country
Korea, Republic of

12. IPD Sharing Statement

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The Visceral Analgesic Effect of Erector Spinae Plane Block in Laparoscopic Cholecystectomy

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