Comparing Analgesic Effects of Caudal and Erector Spinae Plane Blocks in Pediatrics Undergoing Upper Abdominal Surgery

NCT ID: NCT04204343

Last Updated: 2022-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-02-25

Brief Summary

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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.

Detailed Description

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Upper abdominal surgeries are painful and pediatric patients who undergo these operations require effective postoperative pain control. Blockade of dermatomes between T6 and L1 commonly provides effective postoperative analgesia. Epidural and caudal blocks are considered to be the gold standard regional analgesia techniques as they provide both somatic and visceral analgesia. 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 the present study, the aim is to compare postoperative analgesic effects of these two ultrasound-guided techniques in pediatric patients undergoing upper abdominal surgery. 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 (nausea, vomiting, itching, urinary retention, bradycardia, hypotension, respiratory depression), time to first mobilization, length of hospital stay and chronic pain due to incision after 2 months.

Conditions

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Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RANDOMISED DOUBLE BLINDED INTERVENTIONAL
Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Caudal Block

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

Group Type ACTIVE_COMPARATOR

Bupivacaine 0.7 ml/kg

Intervention Type DRUG

Bupivacaine 0.25% 0.7 ml/kg

Erector Spinae Plane Block

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

Group Type ACTIVE_COMPARATOR

Bupivacaine 0.5 ml/kg

Intervention Type DRUG

Bupivacaine 0.25% 0.5 ml/kg

Interventions

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Bupivacaine 0.7 ml/kg

Bupivacaine 0.25% 0.7 ml/kg

Intervention Type DRUG

Bupivacaine 0.5 ml/kg

Bupivacaine 0.25% 0.5 ml/kg

Intervention Type DRUG

Other Intervention Names

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Marcaine Marcaine

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Meltem Savran Karadeniz

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meltem Savran Karadeniz

Role: PRINCIPAL_INVESTIGATOR

Istanbul University Faculty of Medicine Department of Anesthesiology

Locations

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Istanbul University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/30477888

Ultrasound-Guided Single-Shot Preemptive Erector Spinae Plane Block for Postoperative Pain Management.

https://www.ncbi.nlm.nih.gov/pubmed/30412258

Erector Spinae Plane Block in Management of Pain After Kidney Transplantation.

https://www.ncbi.nlm.nih.gov/pubmed/28207652

The Erector Spinae Plane Block.

https://www.ncbi.nlm.nih.gov/pubmed/28337460

Caudal Epidural Block: An Updated Review of Anatomy and Techniques.

https://www.ncbi.nlm.nih.gov/pubmed/30502063

Expert opinion: regional nerve blocks in everyday pediatric urology: 2. Ultrasound-guided regional anesthetic caudal block.

Other Identifiers

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2018/1073

Identifier Type: -

Identifier Source: org_study_id

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