Anesthesia, Local
Conditions
Keywords
thoracic paravertebral block, erector spinae plane block, serratus anterior plane block, ultrasound-guided, thorocotomy pain
Brief summary
This study evaluates the analgesic effects of ultrasound-guided regional techniques, Thoracic Paravertebral Block (TPVB), Erector Spinae Plane Block (ESPB) and Serratus Anterior Plane Block(SAPB) by comparing postoperative total morphine consumption, first analgesic requirement time, and postoperative pain scores ( FLACC/NRS), postoperative chronic pain in 3rd month in pediatric patients undergoing thoracic surgery. The investigators also aim to observe the side effects of these techniques such as nausea, vomiting, bradycardia, hypotension, respiratory depression
Detailed description
Thoracic surgery is one of the most common causes of postoperative severe pain due to the damage to intercostal nerves, irritation of the pleura and rib retraction. Effective analgesia provides patient comfort and enables early mobilization, reducing complications such as pneumonia, respiratory failure, hypoxia, and hypercapnia. In pediatric patients, nonsteroid anti-inflammatory drugs, opioids and regional analgesia techniques can be used for multimodal analgesia. Several side effects of opiates such as respiratory depression, nausea, vomiting, itching, addiction, and sedation effect patients' comfort and delay discharge. Nowadays US-guided truncal block techniques such as thoracic paravertebral block (TPVB) become popular. TPVB provide the somatosensorial and visceral block with an injection of the local anaesthetic agent into the paravertebral space. Existing evidence demonstrates the non inferiority of TPVB compared with TEA for postoperative analgesia and TPVB can reduce side effects. Erector Spina Plan Block (ESPB) was first described in 2016 as an ultrasound-guided truncal block for thoracic neuropathic pain and now ESPB uses for many different thoracics and abdominal surgeries for postoperative analgesia. Several studies have shown that ESPB can provide adequate analgesia in postoperative thoracic pain. ESPB is gaining popularity because its application is easy and safe compared with TPVB. Another new US-guided regional anaesthetic block technique, the serratus anterior plane block (SAPB), targets the plane above or below the serratus anterior muscle in the midaxillary line and provides analgesia to a hemithorax by blocking the lateral branches of the intercostal nerves, thoracicus longus and thoracodorsal nerves. The SAP block provides analgesia to the 2nd and 9th thoracic dermatomes. The SAP block is safe, and easy to perform, owing to its easy-to-learn technique and distinct bony landmarks. So, it can be an attractive alternative for pain relief after thoracic surgery. In this study, Investigators aim to compare the efficacy of these three techniques in pediatric patients. The primary hypothesis is the analgesic efficacy of SAPB will be equivalent to TPVB and RSPB. The primer outcome is postoperative total narcotic analgesic consumption in 24 hours. The seconder outcomes are; time of postoperative first analgesic requirement, postoperative pain scores (FLACC - NRS) in 0.-15.-30.-45.minutes and 1.-2.-6.-12.-24.-48. hours, chronic thoracic pain 3 months after surgery, intraoperative additional fentanyl requirement, postoperative additional paracetamol requirement, intraoperative hemodynamic parameters, first mobilization time, side effects, technical complications, and the satisfaction of patient-surgeon.
Interventions
DRUGBupivacain
%0.25
Sponsors
Istanbul University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Prospective Observational Study
Eligibility
Sex/Gender
ALL
Age
1 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
1-14 age patients undergoing thoracic surgery, ASA 1-2-3, Patients without chronic opioid use
Exclusion criteria
Denial of patient or parents, Infection of the local anaesthetic area, Infection of the central nervous system, Coagulopathy, Brain tumours, Known allergy against local anaesthetics.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Iv Morphine Consumption | Up to 24 hours | The total dosage of iv morphine consumption in 24 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Face, Legs Avtivity, Cry, Consolability (FLACC) scores | Up to 48 hours | It corporates five categories of behavior, each scored on 0-2 point scale so that total score ranges from 0 to 10. Total scores of 0-3 is defined as mild or no pain, 4-7 as moderate, and 8-10 as severe pain |
| Postoperative NRS Score (Numeric Rating Scale) | Up to 48 hours | A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable |
| Time of Postoperative First Analgesic Requirement Time | Up to 48 hours | Time of postoperative first analgesic requirement time. |
| Additional IV Paracetamol Dosage In The Postoperative Period | Up to 48 hours | 15mg/kg iv paracetamol will be administered 30 minutes before extubation. In the postoperative follow-up that will be performed every 6 hours,15mg/kg iv paracetamol will be administered if the FLACC score is \>3 or the NRS score is \>4. |
| Intraoperative Heart Rate (beat/min) | Intraoperative Period | To be measured through the operation at intervals of 5 minutes |
| Intraoperative Mean Arterial Pressure(MAP)(mmHg) | Up to end of the operation | To be measured through the operation at intervals of 5 minutes |
| Number of patients who need intraoperative additional Fentanyl | Up to end of the operation | Intraoperative Additional Fentanyl Requirement |
| Chronic Thoracic Pain | Up to 3 months | Presence of thoracic pain due to the incision after 3 months of the thoracic surgery. |
| Length of Hospital Stay | Up to first week | Length of Hospital Stay |
Other
| Measure | Time frame | Description |
|---|---|---|
| Respiratuar Depression | Up to 48 hours | Incidence of respiratory depression due to ıv morphine in the postoperative follow-up. |
| Postoperative sedation scale | Up to 48 hours | A numerical rating sedation scale requires the patient to rate their sedation on a defined scale. For example, 1: deeply asleep, 2: lightly asleep, 3: drowsy, 4: fully awake and alert |
| Itching | Up to 48 hours | Incidence of itching due to iv morphine in the postoperative follow-up. |
| Incidence of Complications Due To The Regional Block | Up to first week | Incidence of dural puncture,pneumothorax,infection,neural damage. |
| First Mobilization Time | Up to 48 hours | First mobilization time . |
| Need of Intensive Care Unit Follow-Up | Up to 48 hours | The number of patients who need ICU follow-up. |
| Family Satisfaction | Up to 48 hours | Satisfaction score; 0: very unsatisfied 3:very unsatisfied |
| Surgeon Satisfaction | Up to 48 hours | Satisfaction score; 0: very unsatisfied 3:very unsatisfied |
| Incidence of PONV (postoperative nausea and vomiting) | Up to 48 hours | Incidence of postoperative nausea and vomiting. |
Outcome results
None listed