Bilateral vs. Unilateral Erector Spinae Plane Block

NCT ID: NCT03781687

Last Updated: 2019-11-25

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-02

Study Completion Date

2019-06-29

Brief Summary

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The importance of multimodal analgesia for postoperative pain management is well known and regional anesthesia techniques are commonly prefferred to provide better analgesia. Erector spinae plane block (ESB) is a new defined and effective regional anesthesia technique. But two injections can be unconfortable for some patients. With this study, we aimed to compare the analgesia effect of bilateral and unilateral ESP block for laparoscopic cholecystectomy.

Detailed Description

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Conditions

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Postoperative Pain Cholecystitis; Gallstone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Bilateral

Bilateral ESP block will be performed

Group Type ACTIVE_COMPARATOR

Bilateral ESP Block

Intervention Type PROCEDURE

Bilateral ESP Block will be performed at T8

Intravenous Morphine patient controlled analgesia device

Intervention Type DEVICE

24 hour morphine consumption will be recorded

Unilateral

Unilateral ESP block will be performed

Group Type ACTIVE_COMPARATOR

Unilateral ESP Block

Intervention Type PROCEDURE

Unilateral ESP Block will be performed at T8 (right side)

Intravenous Morphine patient controlled analgesia device

Intervention Type DEVICE

24 hour morphine consumption will be recorded

Interventions

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Bilateral ESP Block

Bilateral ESP Block will be performed at T8

Intervention Type PROCEDURE

Unilateral ESP Block

Unilateral ESP Block will be performed at T8 (right side)

Intervention Type PROCEDURE

Intravenous Morphine patient controlled analgesia device

24 hour morphine consumption will be recorded

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ASA I-II patients
* Pateints undergoing elective laparoscopic cholecystectomy

Exclusion Criteria

* obesity (body mass index \>35 kg/m2)
* infection of the skin at the site of needle puncture area
* patients with known allergies to any of the study drugs
* coagulopathy
* recent use of analgesic drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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Can AKSU

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Can Aksu

Role: PRINCIPAL_INVESTIGATOR

Kocaeli Üniversitesi Tıp Fakültesi

Locations

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Kocaeli University Hospital

İzmit, Kocaeli, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KIA 2018/488

Identifier Type: -

Identifier Source: org_study_id

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