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

I

Istanbul University

Status

Completed

Conditions

Anesthesia, Local

Treatments

Drug: Bupivacaine 0.7 ml/kg
Drug: Bupivacaine 0.5 ml/kg

Study type

Interventional

Funder types

Other

Identifiers

NCT04204343
2018/1073

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

1 to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

Caudal Block
Active Comparator group
Description:
US-guided caudal block with 0.7 ml/kg 0.25% Bupivacaine
Treatment:
Drug: Bupivacaine 0.7 ml/kg
Erector Spinae Plane Block
Active Comparator group
Description:
US-guided erector spinae plane block with 0.5 ml/kg 0.25% Bupivacaine
Treatment:
Drug: Bupivacaine 0.5 ml/kg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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