Erector Spinae Plane Block for Postoperative Analgesia for Laparoscopic Cholecystectomy

NCT ID: NCT03420703

Last Updated: 2018-06-15

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

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-24

Study Completion Date

2018-04-18

Brief Summary

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Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented application of this blockade into practice at the clinic. Main purpose of this study is to evaluate the analgesic effect of ultrasound guided erector spinae block in laparoscopic cholecystectomy.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Block group

Erector espine plane block will be administrated to this group. An intravenous patient controlled analgesia device will be given to the patients postoperatively

Group Type ACTIVE_COMPARATOR

erector spinae plane block

Intervention Type OTHER

ultrasound guided erector spinae plane block will be administered to this group.

Intravenous morphine patient controlled analgesia device

Intervention Type DEVICE

Intravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded

control group

An intravenous patient controlled analgesia device will be given to the patients postoperatively

Group Type SHAM_COMPARATOR

Intravenous morphine patient controlled analgesia device

Intervention Type DEVICE

Intravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded

Interventions

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erector spinae plane block

ultrasound guided erector spinae plane block will be administered to this group.

Intervention Type OTHER

Intravenous morphine patient controlled analgesia device

Intravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 25 - 75 years of age
* ASA I - II
* Undergoing elective laparoscopic cholecystectomy

Exclusion Criteria

* obesity
* ASA III - IV
* 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

20 Years

Maximum Eligible Age

75 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

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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2017-349

Identifier Type: -

Identifier Source: org_study_id

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