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

NCT ID: NCT03767816

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-17

Study Completion Date

2019-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Visceral Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group R : Rectus sheath block group

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

Group Type EXPERIMENTAL

Ultrasound guided Rectus sheath block

Intervention Type DRUG

Ultrasound guided rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml around umbilicus

Group RE: Rectus sheath block and erector spinae plane block

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

Group Type ACTIVE_COMPARATOR

Ultrasound guided Rectus sheath block

Intervention Type DRUG

Ultrasound guided rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml around umbilicus

Ultrasound erector spinae plane block

Intervention Type DRUG

Ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml at T7 level

Interventions

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Ultrasound guided Rectus sheath block

Ultrasound guided rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml around umbilicus

Intervention Type DRUG

Ultrasound erector spinae plane block

Ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml at T7 level

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jong Hyuk Lee

clinical assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JongHyuk Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, Songpa-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2018-1320

Identifier Type: -

Identifier Source: org_study_id

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