Errector Spinae Plane Block for Postoperative Pain Management in Cardiac Surgery: A Randomized Controlled Trial

NCT ID: NCT04420104

Last Updated: 2020-07-08

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-06-01

Brief Summary

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The purpose of this study is to assess efficacy of erector spinae plane block (ESP) for postoperative pain management in cardiac surgery patients.

Detailed Description

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After being informed about the study and potential risks, all patients giving written informed consent will be randomised (single blind) as block group(patients is performed esp block) and control group. All patients will be evaluate during 48 hours for postoperative pain.

Conditions

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Erector Spinae Plane Block Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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esp block group

Group Type EXPERIMENTAL

erector spinae plane block

Intervention Type PROCEDURE

ESP Block: Bilateral ESP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline.

iv analgesia

Intervention Type DRUG

iv contromal

control group

Group Type ACTIVE_COMPARATOR

iv analgesia

Intervention Type DRUG

iv contromal

Interventions

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erector spinae plane block

ESP Block: Bilateral ESP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline.

Intervention Type PROCEDURE

iv analgesia

iv contromal

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must be ASA score I-III
* Must be 18-75 years old
* must undergo cardiac surgery

Exclusion Criteria

* emergency surgery,
* bleeding diathesis,
* presence of contraindications to LA agents used in this study,
* use of chronic opioids,
* psychiatric disorders.
* prolonged extubation
* presence of infection at the injection site.
* cardiovascular conditions (EF\<40, LMCA obstruction)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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SINEM SARI

Assoc. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sinem Sari, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Adnan Menderes University Medical Faculty Hospital

Locations

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Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department

Aydin, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Sinem Sari, Assoc Prof

Role: CONTACT

90 507 539 63 13

Facility Contacts

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sinem sari

Role: primary

090 4441256-2108

References

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Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.

Reference Type BACKGROUND
PMID: 30052229 (View on PubMed)

Krishna SN, Chauhan S, Bhoi D, Kaushal B, Hasija S, Sangdup T, Bisoi AK. Bilateral Erector Spinae Plane Block for Acute Post-Surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):368-375. doi: 10.1053/j.jvca.2018.05.050. Epub 2018 Jun 4.

Reference Type BACKGROUND
PMID: 30055991 (View on PubMed)

Other Identifiers

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AMU

Identifier Type: -

Identifier Source: org_study_id

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