Anesthesia, LocalNCT05431062
Comparison of US-guided Single-dose Thoracic Paravertebral, Erector Spinae Plane and Serratus Anterior Plane Blocks
A study testing Bupivacain in people with Anesthesia, Local, run by Istanbul University.
Trial 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 … Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Bupivacain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1-14 age patients undergoing thoracic surgery, ASA 1-2-3, Patients without chronic opioid use
Who cannot join
- 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.
About this study
Official title: 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
Read the 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.
- Conditions
- Anesthesia, Local
- Being tested
- Bupivacain
- Keywords
- thoracic paravertebral block, erector spinae plane block, serratus anterior plane block, ultrasound-guided, thorocotomy pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
Also called Marcaine
%0.25
| Study group | Role | What they receive |
|---|---|---|
| Thoracic paravertebral block | Active comparator | USG guided TPVB will be performed with 0.5 mL/kg %0.25 Buvicaine in the paravertebral space. Receives: Drug: Bupivacain |
| Erector spinae plane block | Active comparator | 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 Receives: Drug: Bupivacain |
| Serratus anterior plane block | Active comparator | 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 Receives: Drug: Bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Iv Morphine Consumption
The total dosage of iv morphine consumption in 24 hours.
Measured: Up to 24 hours
Secondary outcomes (9)
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
Measured: 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
Measured: Up to 48 hours
Time of Postoperative First Analgesic Requirement Time
Time of postoperative first analgesic requirement time.
Measured: 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.
Measured: Up to 48 hours
Intraoperative Heart Rate (beat/min)
To be measured through the operation at intervals of 5 minutes
Measured: Intraoperative Period
Intraoperative Mean Arterial Pressure(MAP)(mmHg)
To be measured through the operation at intervals of 5 minutes
Measured: Up to end of the operation
Number of patients who need intraoperative additional Fentanyl
Intraoperative Additional Fentanyl Requirement
Measured: Up to end of the operation
Chronic Thoracic Pain
Presence of thoracic pain due to the incision after 3 months of the thoracic surgery.
Measured: Up to 3 months
Length of Hospital Stay
Length of Hospital Stay
Measured: Up to first week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Observational Study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Savran Karadeniz, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431062
- Sponsor's protocol ID
- 2021/808
- Status last verified
- Jun 2022
- First submitted
- 10 Jun 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of US-guided Single-dose Thoracic Paravertebral Block, Erector Spinae Plane Block and Serratus Anterior Plane Block in Pediatric Patients Undergoing Thoracic Surgery.
- ClinicalTrials.gov ID
- NCT05431062
- Acronym / sponsor ID
- 2021/808
- Conditions
- Anesthesia, Local
- Keywords
- thoracic paravertebral block, erector spinae plane block, serratus anterior plane block, ultrasound-guided, thorocotomy pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective Observational Study
| Arm | Type | Receives |
|---|---|---|
| Thoracic paravertebral block | Active comparator | Drug: BupivacainUSG guided TPVB will be performed with 0.5 mL/kg %0.25 Buvicaine in the paravertebral space. |
| Erector spinae plane block | Active comparator | Drug: BupivacainUSG guided ESPB will be performed with 0.5 mL/kg %0.25 Buvicaine into the facial plane between erector spine muscle and transverse process |
| Serratus anterior plane block | Active comparator | Drug: BupivacainUSG 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 |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1-14 age patients undergoing thoracic surgery, ASA 1-2-3, Patients without chronic opioid use
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacainAlso: Marcaine%0.25 | Drug | Erector spinae plane block, Serratus anterior plane block, Thoracic paravertebral block |
Primary outcome
Postoperative Iv Morphine Consumption
Time frame: Up to 24 hours
The total dosage of iv morphine consumption in 24 hours.
9 secondary outcomes
Face, Legs Avtivity, Cry, Consolability (FLACC) scores
Time frame: Up to 48 hours
Postoperative NRS Score (Numeric Rating Scale)
Time frame: Up to 48 hours
Time of Postoperative First Analgesic Requirement Time
Time frame: Up to 48 hours
Additional IV Paracetamol Dosage In The Postoperative Period
Time frame: Up to 48 hours
Intraoperative Heart Rate (beat/min)
Time frame: Intraoperative Period
Intraoperative Mean Arterial Pressure(MAP)(mmHg)
Time frame: Up to end of the operation
Number of patients who need intraoperative additional Fentanyl
Time frame: Up to end of the operation
Chronic Thoracic Pain
Time frame: Up to 3 months
Length of Hospital Stay
Time frame: Up to first week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacain in people with Anesthesia, Local, run by Istanbul University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Iv Morphine Consumption (time frame: Up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.