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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

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 groups in NCT05431062
Study groupRoleWhat they receive
Thoracic paravertebral blockActive comparatorUSG guided TPVB will be performed with 0.5 mL/kg %0.25 Buvicaine in the paravertebral space.
Receives: Drug: Bupivacain
Erector spinae plane blockActive comparatorUSG 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 blockActive comparatorUSG 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.

  1. Postoperative Iv Morphine Consumption

    The total dosage of iv morphine consumption in 24 hours.

    Measured: Up to 24 hours

Secondary outcomes (9)
  1. 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

  2. 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

  3. Time of Postoperative First Analgesic Requirement Time

    Time of postoperative first analgesic requirement time.

    Measured: Up to 48 hours

  4. 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

  5. Intraoperative Heart Rate (beat/min)

    To be measured through the operation at intervals of 5 minutes

    Measured: Intraoperative Period

  6. Intraoperative Mean Arterial Pressure(MAP)(mmHg)

    To be measured through the operation at intervals of 5 minutes

    Measured: Up to end of the operation

  7. Number of patients who need intraoperative additional Fentanyl

    Intraoperative Additional Fentanyl Requirement

    Measured: Up to end of the operation

  8. Chronic Thoracic Pain

    Presence of thoracic pain due to the incision after 3 months of the thoracic surgery.

    Measured: Up to 3 months

  9. 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.

  1. First posted24 Jun 2022
  2. Study start1 Jul 2022 (estimated)
  3. Primary completion1 Nov 2022 (estimated)
  4. Study completion1 Apr 2023 (estimated)

Resources

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)
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

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.

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