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

March 28, 2022 updated by: Meltem Savran Karadeniz, Istanbul University

Comparing Analgesic Effects of Ultrasound-Guided Caudal and Erector Spinae Plane Blocks in Pediatric Patients Undergoing Upper Abdominal Surgery: A Randomized Controlled Double-Blinded Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34093
        • Istanbul University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Caudal Block
US-guided caudal block with 0.7 ml/kg 0.25% Bupivacaine
Drug: Bupivacaine 0.7 ml/kg
Bupivacaine 0.25% 0.7 ml/kg
Other Names:
  • Marcaine
ACTIVE_COMPARATOR: Erector Spinae Plane Block
US-guided erector spinae plane block with 0.5 ml/kg 0.25% Bupivacaine
Drug: Bupivacaine 0.5 ml/kg
Bupivacaine 0.25% 0.5 ml/kg
Other Names:
  • Marcaine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of hospital stay
Time Frame: through study completion, an average of 1 week
hospitalisation
through study completion, an average of 1 week
number patients who require rescue analgesic
Time Frame: up to 48 hours
number of patients who require IV morphine (0.03 mg/kg) during the first 2 hours and paracetamol in the 48 hours
up to 48 hours
Time to first analgesic
Time Frame: up to 48 hours
Duration of postoperative analgesia
up to 48 hours
Incidence of side effects/complications
Time Frame: up to first week
hematoma, dural puncture, infections
up to first week
Time to first mobilization
Time Frame: up to 48 hours
time to first mobilization
up to 48 hours
Presence of pain (chronic pain - Visual Analog scale>3)
Time Frame: 3 months
Chronic pain due to incision after 2-3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ACTUAL)

January 15, 2022

Study Completion (ACTUAL)

February 25, 2022

Study Registration Dates

First Submitted

December 16, 2019

First Submitted That Met QC Criteria

December 17, 2019

First Posted (ACTUAL)

December 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/1073

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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