Comparing Analgesic Effects of Caudal and Erector Spinae... | NCT04204343

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

NCT04204343

Sponsor

Istanbul University

Status

Completed

Last Update Posted

Mar 29, 2022Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Anesthesia, Local

Interventions

Bupivacaine 0.7 ml/kg
Bupivacaine 0.5 ml/kg

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Jan 15, 2022Actual

Completion Date

Feb 25, 2022Actual

First Submitted Date

Dec 16, 2019

First Submission Date that Met QC Criteria

Dec 17, 2019

First Posted Date

Dec 18, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2022

Last Update Posted Date

Mar 29, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Meltem Savran Karadeniz, Associate Professor, Istanbul UniversityPrincipal Investigator

Lead Sponsor

Istanbul UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Bupivacaine 0.7 ml/kg	Drug	Bupivacaine 0.25% 0.7 ml/kg	Caudal Block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Face, Legs, Activity, Cry, Consolability scale/Visual Analog scale	Pain scores between 0-10	up to 48 hours

Secondary Outcomes

Measure	Description	Time Frame
length of hospital stay	hospitalisation	through study completion, an average of 1 week
number patients who require rescue analgesic	number of patients who require IV morphine (0.03 mg/kg) during the first 2 hours and paracetamol in the 48 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Meltem Savran Karadeniz	Istanbul University Faculty of Medicine Department of Anesthesiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul University		Istanbul		34093	Turkey (Türkiye)

References Module

Citations

Not provided

Label	URL
Ultrasound-Guided Single-Shot Preemptive Erector Spinae Plane Block for Postoperative Pain Management.	View source
Erector Spinae Plane Block in Management of Pain After Kidney Transplantation.	View source
The Erector Spinae Plane Block.

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds