NCT05415046

Brief Summary

Patients who were operated by Department of Pediatric Surgery and who received sacral erector spinae plane blocks as a part of postoperative analgesia management will be scanned.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

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

June 4, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

June 15, 2022

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2022

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

22 days

First QC Date

June 4, 2022

Last Update Submit

August 16, 2022

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (3)

  • Face, Legs, Activity, Cry, Consolability (FLACC) Scale

    The scale is scored in a range of 0-10 with 0 representing no pain (meaning a better outcome). The scale has five criteria, which are each assigned a score of 0, 1 or 2.

    Postoperative 24th hour.

  • Rescue analgesic-paracetamol

    The need and amount of the IV paracetamol given

    During the postoperative 24th hour.

  • Rescue analgesic-ibuprofen

    The need and amount of the oral ibuprofen given

    During the postoperative 24th hour.

Study Arms (1)

Sacral ESPB

Sacral erector spinae plane block performed with 0,25% bupivacaine (1 mL/kg-max 20mL), under general anesthesia before the start of the surgery.

Procedure: Sacral ESPB

Interventions

Sacral ESPBPROCEDURE

Erector spinae plane block performed with 0,25% bupivacaine (1 mL/kg-max 20mL), under general anesthesia before the start of the surgery.

Sacral ESPB

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients who were operated by Department of Pediatric Surgery and performed sacral ESPB for postoperative analgesia.

You may qualify if:

  • Patients who were operated by Department of Pediatric Surgery

You may not qualify if:

  • Incomplete patient forms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University Hospital

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Principal investigator.

Study Record Dates

First Submitted

June 4, 2022

First Posted

June 10, 2022

Study Start

June 15, 2022

Primary Completion

July 7, 2022

Study Completion

July 8, 2022

Last Updated

August 17, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)