Comparison of US-guided Single-dose Thoracic Paravertebral, Erector Spinae Plane and Serratus Anterior Plane Blocks

Comparison of US-guided Single-dose Thoracic Paravertebral Block, Erector Spinae Plane Block and Serratus Anterior Plane Block in Pediatric Patients Undergoing Thoracic Surgery.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia, Local
• Intervention / Treatment: Drug: Bupivacain

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Thoracic paravertebral block; USG guided TPVB will be performed with 0.5 mL/kg %0.25 Buvicaine in the paravertebral space.	Drug: Bupivacain; %0.25; Other Names: Marcaine
Active Comparator: Erector spinae plane block; USG guided ESPB will be performed with 0.5 mL/kg %0.25 Buvicaine into the facial plane between erector spine muscle and transverse process	Drug: Bupivacain; %0.25; Other Names: Marcaine
Active Comparator: Serratus anterior plane block; USG guided ESPB will be performed with 0.5 mL/kg %0.25 Buvicaine into the facial plane between serratus anterior muscle and external intercostal muscles	Drug: Bupivacain; %0.25; Other Names: Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Iv Morphine Consumption	The total dosage of iv morphine consumption in 24 hours.	Up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Face, Legs Avtivity, Cry, Consolability (FLACC) scores	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	Up to 48 hours
Postoperative NRS Score (Numeric Rating Scale)	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	Up to 48 hours
Time of Postoperative First Analgesic Requirement Time	Time of postoperative first analgesic requirement time.	Up to 48 hours
Additional IV Paracetamol Dosage In The Postoperative Period	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.	Up to 48 hours
Intraoperative Heart Rate (beat/min)	To be measured through the operation at intervals of 5 minutes	Intraoperative Period
Intraoperative Mean Arterial Pressure(MAP)(mmHg)	To be measured through the operation at intervals of 5 minutes	Up to end of the operation
Number of patients who need intraoperative additional Fentanyl	Intraoperative Additional Fentanyl Requirement	Up to end of the operation
Chronic Thoracic Pain	Presence of thoracic pain due to the incision after 3 months of the thoracic surgery.	Up to 3 months
Length of Hospital Stay	Length of Hospital Stay	Up to first week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of PONV (postoperative nausea and vomiting)	Incidence of postoperative nausea and vomiting.	Up to 48 hours
Respiratuar Depression	Incidence of respiratory depression due to ıv morphine in the postoperative follow-up.	Up to 48 hours
Postoperative sedation scale	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	Up to 48 hours
Itching	Incidence of itching due to iv morphine in the postoperative follow-up.	Up to 48 hours
Incidence of Complications Due To The Regional Block	Incidence of dural puncture,pneumothorax,infection,neural damage.	Up to first week
First Mobilization Time	First mobilization time .	Up to 48 hours
Need of Intensive Care Unit Follow-Up	The number of patients who need ICU follow-up.	Up to 48 hours
Family Satisfaction	Satisfaction score; 0: very unsatisfied 3:very unsatisfied	Up to 48 hours
Surgeon Satisfaction	Satisfaction score; 0: very unsatisfied 3:very unsatisfied	Up to 48 hours

Collaborators and Investigators

• Sponsor: Istanbul University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 18, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): June 24, 2022
• Last Update Submitted That Met QC Criteria: June 18, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: ultrasound-guided; serratus anterior plane block; thoracic paravertebral block; erector spinae plane block; thorocotomy pain
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 2021/808

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No