NCT03808129

Brief Summary

Brief summary: Regional anesthesia decreases the need for intravenous analgesia in the peri-operative period. Erector spinae plane (ESP) is a regional anesthesia technique shown to be effective at the dorsal and ventral rami of the thoracic spinal nerve along with sympathetic nerve fibers. The purpose is to demonstrate the contribution of ESP block to the postoperative analgesia by ultrasonography and to increase intraabdominal tissue oxygenation compared to the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 17, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

January 18, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2019

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2019

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

December 13, 2018

Last Update Submit

March 19, 2020

Conditions

Lower Abdominal Surgery

Keywords

erector spinae plane blockpostoperative analgesiaRSO2

Outcome Measures

Primary Outcomes (2)

  • FLACC scale

    FLACC scale was used. The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale was a measurement used to assess pain for children between the ages of 6 months and 2 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.

    From recovery of anesthesia to end of study ( postoperative 24 hours)

  • NIRS

    INVOS ;Somatic Corp, Troy, Mic sensors placed in surgical side of patients was used to detect peripheral perfusion and oxygen delivery (rSo2)

    Before anesthesia induction to end of operation ( intraoperative 2 hours )

Secondary Outcomes (2)

  • Time to first analgesic drug

    first 24 hour

  • Need for analgesic

    first 24 hour

Study Arms (2)

ESP Group: Bupivacaine and lidocaine

ACTIVE COMPARATOR

ESP Group: Bupivacaine and lidocaine: Erector Spinae Plane Block : (1: 1 ratio of 0.25% bupivacaine and 0.4 ml / kg of 1% lidocaine) was administered.

Drug: Bupivacaine and Lidocaine

control group

NO INTERVENTION

Control Group:

Interventions

Bupivacaine and LidocaineDRUG

ESP block was administered under general anesthesia before the surgery. Patients with ESP block, 1: 1 ratio of 0.25% bupivacaine and 0.4 ml / kg of 1% lidocaine

Also known as: ESP block
ESP Group: Bupivacaine and lidocaine

Eligibility Criteria

Age6 Months - 2 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 6 months to 2 years
  • According to American Anesthesia Society Anesthesia Risk Scale ASA I-II class patients
  • Patients with lower abdominal surgery

You may not qualify if:

  • Children under 6 months and older than 2 years
  • According to American Anesthesia Society Anesthesia Risk Scale Patients with ASA III-IV class
  • Patients with contraindication to regional anesthesia
  • Patients with a history of local anesthetic allergy
  • Patients with abnormal coagulation profile
  • Patients with infection at the injection site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parvin Pinar

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Interventions

BupivacaineLidocaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAcetanilides

Study Officials

  • PARVIN PINAR

    BEZMİALEM VAKIF UNIVERSITY

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
As the patients were under 18 years of age, the details of the procedure were explained to their parents and their consent was obtained. However, the patients were not included in the group. And also outcomes assessor staff were not aware of medication assignment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2018

First Posted

January 17, 2019

Study Start

January 18, 2019

Primary Completion

April 12, 2019

Study Completion

April 20, 2019

Last Updated

March 20, 2020

Record last verified: 2020-03

Locations

TU(1)