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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Istanbul University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The Face, Legs, Activity, Cry, Consolability scale/Visual Analog scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Year to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Caudal Block
US-guided caudal block with 0.7 ml/kg 0.25% Bupivacaine
Intervention: Bupivacaine 0.7 ml/kg (Drug)
Erector Spinae Plane Block
US-guided erector spinae plane block with 0.5 ml/kg 0.25% Bupivacaine
Intervention: Bupivacaine 0.5 ml/kg (Drug)
Outcomes
Primary Outcomes
The Face, Legs, Activity, Cry, Consolability scale/Visual Analog scale
Time Frame: up to 48 hours
Pain scores between 0-10
Secondary Outcomes
- length of hospital stay(through study completion, an average of 1 week)
- number patients who require rescue analgesic(up to 48 hours)
- Time to first analgesic(up to 48 hours)
- Incidence of side effects/complications(up to first week)
- Time to first mobilization(up to 48 hours)
- Presence of pain (chronic pain - Visual Analog scale>3)(3 months)
Investigators
Meltem Savran Karadeniz
Associate Professor
Istanbul University