Injection Rate and Erector Spinae Plane Block

NCT ID: NCT04895072

Last Updated: 2022-01-04

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

2021-05-17

Study Completion Date

2021-11-30

Brief Summary

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To evaluate the effect of injection rate on the block sensory level in the ESP block.

Detailed Description

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Many women experience severe acute postoperative pain after breast cancer surgery. Regional techniques are frequently used as a part of multimodal analgesia in breast surgery. Ultrasound-guided erector spinae plane (ESP) block is a preferred method to reduce the postoperative opioid requirement for postoperative pain management. In this study, we aimed to evaluate the effect of injection rate on the block sensory level in the ESP block.

Conditions

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Postoperative Pain Breast Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard group

standard injection rate will be applied

Group Type ACTIVE_COMPARATOR

Standard group

Intervention Type PROCEDURE

Ultrasound-guided ESP block with 20 mL %0.375 bupivacaine will be administered at a standard injection rate.

Long group

long injection rate will be applied

Group Type ACTIVE_COMPARATOR

Long group

Intervention Type PROCEDURE

Ultrasound-guided ESP block with 20 mL %0.375 bupivacaine will be administered at a long injection rate.

Interventions

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Standard group

Ultrasound-guided ESP block with 20 mL %0.375 bupivacaine will be administered at a standard injection rate.

Intervention Type PROCEDURE

Long group

Ultrasound-guided ESP block with 20 mL %0.375 bupivacaine will be administered at a long injection rate.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* aged between eighteen and sixty-five
* ASA I-III
* undergo elective breast cancer surgery

Exclusion Criteria

* under 18 years of age or over 65 years of age
* ASA IV and above
* declined to give written informed consent
* contraindications of peripheral blocks or local anesthetic infiltration
* history of allergy against local anesthetics
* chronic pain history
* history of hepatic, neuromuscular, cardiac and/or renal failure
* infection at the injection site
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arzu Karaveli

Role: PRINCIPAL_INVESTIGATOR

Antalya TRH

Locations

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Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Barrios A, Camelo J, Gomez J, Forero M, Peng PWH, Visbal K, Cadavid A. Evaluation of Sensory Mapping of Erector Spinae Plane Block. Pain Physician. 2020 Jun;23(3):E289-E296.

Reference Type BACKGROUND
PMID: 32517405 (View on PubMed)

Other Identifiers

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4/5

Identifier Type: -

Identifier Source: org_study_id

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