Anesthesia, Local
Conditions
Keywords
Erector Spinae Plane Block, Caudal Block, Ultrasound guidance, Postoperative analgesia, Upper abdominal surgery
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.
Interventions
DRUGBupivacaine 0.7 ml/kg
Bupivacaine 0.25% 0.7 ml/kg
DRUGBupivacaine 0.5 ml/kg
Bupivacaine 0.25% 0.5 ml/kg
Sponsors
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
RANDOMISED DOUBLE BLINDED INTERVENTIONAL
Eligibility
Sex/Gender
ALL
Age
1 Years to 12 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Face, Legs, Activity, Cry, Consolability scale/Visual Analog scale | up to 48 hours | Pain scores between 0-10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number patients who require rescue analgesic | 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 |
| Time to first analgesic | up to 48 hours | Duration of postoperative analgesia |
| length of hospital stay | through study completion, an average of 1 week | hospitalisation |
| Time to first mobilization | up to 48 hours | time to first mobilization |
| Presence of pain (chronic pain - Visual Analog scale>3) | 3 months | Chronic pain due to incision after 2-3 months |
| Incidence of side effects/complications | up to first week | hematoma, dural puncture, infections |
Countries
Turkey (Türkiye)
Outcome results
None listed