Clinical trial NCT04204343: Comparing Analgesic Effects of Caudal and Erector Spinae Plane Blocks in Pediatrics Undergoing Upper Abdominal Surgery
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Keywords: Erector Spinae Plane Block
Caudal Block
Ultrasound guidance
Postoperative analgesia
Upper abdominal surgery
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RANDOMISED DOUBLE BLINDED INTERVENTIONAL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: The Face, Legs, Activity, Cry, Consolability scale/Visual Analog scale
timeFrame: up to 48 hours
Secondary outcomes:
measure: length of hospital stay
timeFrame: through study completion, an average of 1 week
measure: number patients who require rescue analgesic
timeFrame: up to 48 hours
measure: Time to first analgesic
timeFrame: up to 48 hours
measure: Incidence of side effects/complications
timeFrame: up to first week
measure: Time to first mobilization
timeFrame: up to 48 hours
measure: Presence of pain (chronic pain - Visual Analog scale>3)
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
affiliation: Istanbul University Faculty of Medicine Department of Anesthesiology
name: Meltem Savran Karadeniz
role: PRINCIPAL_INVESTIGATOR
References: