Sacral Erector Spinae Plane Blocks in Pediatric Patients

Sponsor

Kocaeli University (Other)

Overall Status

Completed

CT.gov ID

NCT05415046

Collaborator

(none)

Enrollment

Location

Actual Duration (Days)

19.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Procedure: Sacral ESPB

Detailed Description

Erector spinae plane block (ESPB) is a safe and effective regional anesthesia technique in pediatric patients and can be performed at any level of the thoracic and lumbar vertebrae. In addition, ESPB can be performed at the sacral region in the midline. In pediatric patients, sacral ESPB provides effective analgesia and this method can replace caudal blocks.

This study aims to investigate the efficacy of sacral ESPB retrospectively. Demographical data of the patient, indication/surgery type, total volume applied, additional analgesic use, type of the analgesic if used will be investigated.

Study Design

Study Type:

Observational

Actual Enrollment :

15 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Retrospective Analyses of Sacral Erector Spinae Plane Blocks in Pediatric Patients: Is it Time to Discuss the Necessity of Caudal Block

Actual Study Start Date :

Jun 15, 2022

Actual Primary Completion Date :

Jul 7, 2022

Actual Study Completion Date :

Jul 8, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

Face, Legs, Activity, Cry, Consolability (FLACC) Scale [Postoperative 24th hour.]
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.
Rescue analgesic-paracetamol [During the postoperative 24th hour.]
The need and amount of the IV paracetamol given
Rescue analgesic-ibuprofen [During the postoperative 24th hour.]
The need and amount of the oral ibuprofen given

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 18 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Patients who were operated by Department of Pediatric Surgery

Exclusion Criteria:

Incomplete patient forms

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kocaeli University Hospital	Kocaeli		Turkey

Sponsors and Collaborators

Kocaeli University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Can AKSU, MD, Principal investigator., Kocaeli University

ClinicalTrials.gov Identifier:

NCT05415046

Other Study ID Numbers:

GOKAEK-2021/6.04

First Posted:

Jun 10, 2022

Last Update Posted:

Aug 17, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Aug 17, 2022