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Completed

NCT Number: NCT04204343

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

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.

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Key information

Conditions

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University

Istanbul, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine 0.7 ml/kg

Drug

Bupivacaine 0.25% 0.7 ml/kg

Other names: Marcaine

Bupivacaine 0.5 ml/kg

Drug

Bupivacaine 0.25% 0.5 ml/kg

Other names: Marcaine

Primary outcomes

  1. The Face, Legs, Activity, Cry, Consolability scale/Visual Analog scale

    Time frame: up to 48 hours

    Pain scores between 0-10

Secondary outcomes

  1. length of hospital stay

    Time frame: through study completion, an average of 1 week

    hospitalisation

  2. 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

  3. Time to first analgesic

    Time frame: up to 48 hours

    Duration of postoperative analgesia

  4. Incidence of side effects/complications

    Time frame: up to first week

    hematoma, dural puncture, infections

  5. Time to first mobilization

    Time frame: up to 48 hours

    time to first mobilization

  6. Presence of pain (chronic pain - Visual Analog scale>3)

    Time frame: 3 months

    Chronic pain due to incision after 2-3 months

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 18, 2019
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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