Preemptive Analgesic Effects of Rectus Sheath Block in Laparoscopic Cholecystectomy Patients

NCT ID: NCT03413280

Last Updated: 2019-01-23

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-28

Study Completion Date

2018-01-15

Brief Summary

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The purpose of this study was to investigate the effectiveness of preemptive effect of rectus sheath block (RSB) and intercostal nerve block (ICNB) on postoperative visceral pain in laparoscopic cholecystectomy (LLC).

After induction of general anesthesia, group of patient is decided randomly. In Group pre, RSB and ICNB are performed with 0.25% Ropivacaine 40ml before the operation. In Group post, RSB and ICNB are performed with 0.25% Ropivacaine 40ml after the operation.

Measure the NRS and compare the rescue analgesic dose used at 0, 0.5, 1, 2, 6, 9, 18, and 24 hours after arrival at the recovery room.

Detailed Description

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Conditions

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Preemptive Peripheral Nerve Block Pain, Postoperative Acute Pain

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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preoperative Rectus sheath block: group Pre

ultrasound guided Rectus sheath block block with 0.25% ropivacaine 40ml Before surgical incision

Group Type EXPERIMENTAL

Ultrasound guided Rectus sheath block

Intervention Type DRUG

Ultrasound guided rectus sheath block with 0.25% ropivacaine 34ml around umbilicus

Intercostal nerve block

Intervention Type DRUG

Ultrasound guided intercostal nerve block with 0.25% ropivacaine 6ml in 7,8,9 th intercostal space

postoperative Rectus sheath block: group Post

ultrasound guided Rectus sheath block block with 0.25% ropivacaine 40ml After surgical incision

Group Type ACTIVE_COMPARATOR

Ultrasound guided Rectus sheath block

Intervention Type DRUG

Ultrasound guided rectus sheath block with 0.25% ropivacaine 34ml around umbilicus

Intercostal nerve block

Intervention Type DRUG

Ultrasound guided intercostal nerve block with 0.25% ropivacaine 6ml in 7,8,9 th intercostal space

Interventions

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Ultrasound guided Rectus sheath block

Ultrasound guided rectus sheath block with 0.25% ropivacaine 34ml around umbilicus

Intervention Type DRUG

Intercostal nerve block

Ultrasound guided intercostal nerve block with 0.25% ropivacaine 6ml in 7,8,9 th intercostal space

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. ASA class 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 who are pregnant or lactating
6. Patients whose visceral pain is expected to be too severe
7. Patients receiving a single laparoscopic cholecystectomy (including using a robot)
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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2017-0301

Identifier Type: -

Identifier Source: org_study_id

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