Injection Rate and Erector Spinae Plane Block

December 14, 2021 updated by: Antalya Training and Research Hospital

Effect of Injection Rate on the Block Sensory Level in the Erector Spine Plane Block

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey, 07100
        • Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard group
standard injection rate will be applied
Procedure: Standard group
Ultrasound-guided ESP block with 20 mL %0.375 bupivacaine will be administered at a standard injection rate.
Active Comparator: Long group
long injection rate will be applied
Procedure: Long group
Ultrasound-guided ESP block with 20 mL %0.375 bupivacaine will be administered at a long injection rate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Block sensory level
Time Frame: 12 hours
Number (average) of dermatomes with sensory block with pinprick and cold methods after the ESP block
12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative tramadol consumption
Time Frame: 24 hours
Postoperative tramadol consumption will be recorded at 24 hours
24 hours
Assesment of postoperative analgesia
Time Frame: 24 hours
Post operative pain scores will be assessed using a numerical rating scala (NRS) (from 0=no pain, to10= worst pain imaginable).
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antalya Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2021

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

May 17, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

January 4, 2022

Last Update Submitted That Met QC Criteria

December 14, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4/5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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