NCT04204343

Brief Summary

Upper abdominal surgeries are painful and pediatric patients who undergo these operations require effective postoperative pain control. Epidural and caudal blocks are considered to be the gold standard regional analgesia techniques. Currently, ultrasound guidance is commonly used for caudal block performances to demonstrate the cannula placement and the deposition of local anesthetic. Additionally, erector spinae plane block can be a safer alternative for blocking the similar dermatomes. In this study, the aim is to compare postoperative analgesic effects of these two ultrasound-guided techniques in pediatric patients. The primary outcome of this study is the follow-up of FLACC/VAS pain scores. Secondary outcomes are time to first analgesic requirement, number of patients who require rescue analgesic, possible side effects, time to first mobilization, length of hospital stay and chronic pain due to incision after 2 months.

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

Timeline
Completed

Started Jan 2019

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2022

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

3 years

First QC Date

December 16, 2019

Last Update Submit

March 28, 2022

Conditions

Anesthesia, Local

Keywords

Erector Spinae Plane BlockCaudal BlockUltrasound guidancePostoperative analgesiaUpper abdominal surgery

Outcome Measures

Primary Outcomes (1)

  • The Face, Legs, Activity, Cry, Consolability scale/Visual Analog scale

    Pain scores between 0-10

    up to 48 hours

Secondary Outcomes (6)

  • length of hospital stay

    through study completion, an average of 1 week

  • number patients who require rescue analgesic

    up to 48 hours

  • Time to first analgesic

    up to 48 hours

  • Incidence of side effects/complications

    up to first week

  • Time to first mobilization

    up to 48 hours

  • +1 more secondary outcomes

Study Arms (2)

Caudal Block

ACTIVE COMPARATOR

US-guided caudal block with 0.7 ml/kg 0.25% Bupivacaine

Drug: Bupivacaine 0.7 ml/kg

Erector Spinae Plane Block

ACTIVE COMPARATOR

US-guided erector spinae plane block with 0.5 ml/kg 0.25% Bupivacaine

Drug: Bupivacaine 0.5 ml/kg

Interventions

Bupivacaine 0.7 ml/kgDRUG

Bupivacaine 0.25% 0.7 ml/kg

Also known as: Marcaine
Caudal Block
Bupivacaine 0.5 ml/kgDRUG

Bupivacaine 0.25% 0.5 ml/kg

Also known as: Marcaine
Erector Spinae Plane Block

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • undergoing upper abdominal surgery
  • ASA(American Society of Anesthesiology)1-2

You may not qualify if:

  • denial of patient or parents
  • infection on the local anesthetic application area
  • infection in the central nervous system
  • coagulopathy
  • brain tumors
  • known allergy against local anesthetics
  • anatomical difficulties
  • with preexisting cardiac dysfunction
  • with history of renal and/or hepatic dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Istanbul, 34093, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Meltem Savran Karadeniz

    Istanbul University Faculty of Medicine Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: RANDOMISED DOUBLE BLINDED INTERVENTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 16, 2019

First Posted

December 18, 2019

Study Start

January 1, 2019

Primary Completion

January 15, 2022

Study Completion

February 25, 2022

Last Updated

March 29, 2022

Record last verified: 2022-03

Locations

TU(1)