NCT04895072

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

May 17, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

January 4, 2022

Status Verified

May 1, 2021

Enrollment Period

7 months

First QC Date

May 17, 2021

Last Update Submit

December 14, 2021

Conditions

Postoperative PainBreast Surgery

Keywords

Erector spinae plane (ESP) blockPostoperative PainBreast Surgery

Outcome Measures

Primary Outcomes (1)

  • Block sensory level

    Number (average) of dermatomes with sensory block with pinprick and cold methods after the ESP block

    12 hours

Secondary Outcomes (2)

  • Postoperative tramadol consumption

    24 hours

  • Assesment of postoperative analgesia

    24 hours

Study Arms (2)

Standard group

ACTIVE COMPARATOR

standard injection rate will be applied

Procedure: Standard group

Long group

ACTIVE COMPARATOR

long injection rate will be applied

Procedure: Long group

Interventions

Standard groupPROCEDURE

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

Standard group
Long groupPROCEDURE

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

Long group

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Antalya, 07100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 32517405BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeBites and Stings

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Arzu Karaveli

    Antalya TRH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2021

First Posted

May 20, 2021

Study Start

May 17, 2021

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

January 4, 2022

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)