Comparison of US-guided Single-dose Thoracic Paravertebral, Erector Spinae Plane and Serratus Anterior Plane Blocks
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
This study evaluates the analgesic effects of ultrasound-guided regional techniques, Thoracic Paravertebral Block (TPVB), Erector Spinae Plane Block (ESPB) and Serratus Anterior Plane Block(SAPB) by comparing postoperative total morphine consumption, first analgesic requirement time, and postoperative pain scores ( FLACC/NRS), postoperative chronic pain in 3rd month in pediatric patients undergoing thoracic surgery. The investigators also aim to observe the side effects of these techniques such as nausea, vomiting, bradycardia, hypotension, respiratory depression
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2022
Shorter than P25 for not_applicable
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
June 10, 2022
CompletedFirst Posted
Study publicly available on registry
June 24, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedJune 24, 2022
June 1, 2022
4 months
June 10, 2022
June 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative Iv Morphine Consumption
The total dosage of iv morphine consumption in 24 hours.
Up to 24 hours
Secondary Outcomes (9)
Face, Legs Avtivity, Cry, Consolability (FLACC) scores
Up to 48 hours
Postoperative NRS Score (Numeric Rating Scale)
Up to 48 hours
Time of Postoperative First Analgesic Requirement Time
Up to 48 hours
Additional IV Paracetamol Dosage In The Postoperative Period
Up to 48 hours
Intraoperative Heart Rate (beat/min)
Intraoperative Period
- +4 more secondary outcomes
Other Outcomes (9)
Incidence of PONV (postoperative nausea and vomiting)
Up to 48 hours
Respiratuar Depression
Up to 48 hours
Postoperative sedation scale
Up to 48 hours
- +6 more other outcomes
Study Arms (3)
Thoracic paravertebral block
ACTIVE COMPARATORUSG guided TPVB will be performed with 0.5 mL/kg %0.25 Buvicaine in the paravertebral space.
Erector spinae plane block
ACTIVE COMPARATORUSG guided ESPB will be performed with 0.5 mL/kg %0.25 Buvicaine into the facial plane between erector spine muscle and transverse process
Serratus anterior plane block
ACTIVE COMPARATORUSG guided ESPB will be performed with 0.5 mL/kg %0.25 Buvicaine into the facial plane between serratus anterior muscle and external intercostal muscles
Interventions
%0.25
Eligibility Criteria
You may qualify if:
- age patients undergoing thoracic surgery, ASA 1-2-3, Patients without chronic opioid use
You may not qualify if:
- Denial of patient or parents, Infection of the local anaesthetic area, Infection of the central nervous system, Coagulopathy, Brain tumours, Known allergy against local anaesthetics.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associated professor
Study Record Dates
First Submitted
June 10, 2022
First Posted
June 24, 2022
Study Start
July 1, 2022
Primary Completion
November 1, 2022
Study Completion
April 1, 2023
Last Updated
June 24, 2022
Record last verified: 2022-06