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Thoracotomy SurgeryNCT07799844

Ultrasound-guided Thoracic Mid-Point Transverse Process to Pleural Block Versus Thoracic Paravertebral Block for Post Thoracotomy Analgesia

A study testing Group A (Thoracic Paravertebral Block ) and Group B : thoracic Mid-Point Transverse Process to Pleural Block in people with Thoracotomy Surgery and Analgesia, run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to compare the analgesic efficacy and safety of midpoint transverse process to pleura to pleural block versus Paravertebral block for post thoracic surgery analgesia. Primary outcome: Postoperative morphine consumption in the first 24 hours after surgery. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Group A (Thoracic Paravertebral Block ) and Group B : thoracic Mid-Point Transverse Process to Pleural Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
30 Jan 2024to 30 Sep 2024
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged from 18 to 65 years old
  • both sexes, American Society of Anesthesiologists (ASA) classification I \& II
  • scheduled for elective thoracotomy.

Who cannot join

  • Patient refusal.
  • BMI ≥ 35.
  • Bleeding diathesis.
  • Patients with local anesthetic allergy.
  • Neurological disease.
  • Infections at the needle site.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Tanta University

    Tanta

Other trials in Egypt

About this study

Official title: Comparison Between Ultrasound-guided Thoracic Mid-Point Transverse Process to Pleural Block Versus Thoracic Paravertebral Block for Post Thoracotomy Analgesia: Randomized Controlled Trial

The aim of the study is to compare the analgesic efficacy and safety of midpoint transverse process to pleura to pleural block versus Paravertebral block for post thoracic surgery analgesia.

Primary outcome:

Postoperative morphine consumption in the first 24 hours after surgery.

Secondary outcomes:

  • Time to the first rescue analgesia .
  • The amount of rescue analgesics.
  • Postoperative visual analog scale pain scores.
  • Complications as inadvertent pleural puncture, intravascular injection, epidural, subdural and subarachnoid injection, hypotension, bradycardia\& local Anesthetic systemic toxicity .
Read the detailed description

A posterolateral thoracotomy provides good access to the lung, middle and posterior mediastinum, hilum, endothoracic trachea, and endothoracic esophagus, while also allowing for safe control of pulmonary blood vessels during pulmonary resection. There are two potential disadvantages to the posterolateral thoracotomy; they are that it is painful aid that it may disturb the respiratory mechanics through division of respiratory muscles and decreased mobility of the chest wall. Respiratory distress may ensue because of chest muscular contraction, which hinders the capacity of the lungs to expand and contract. Thoracic spine and chest wall pain is less prevalent than lumbar or cervical area pain, but it has been reported to affect 13% to 15% of the total population. Moreover, persistent thoracic spine and chest wall pain could impair activities of daily living and cause decline in the quality of life Many patients may develop post-operative thoracotomy pain syndrome defined as "pain that recurs or continues along a thoracotomy scar at least 2 months after the surgery" because of insufficient postoperative pain treatment . In lung surgery, acute postoperative pain prevents deep breathing and coughing, with a strong relationship between pain and respiratory problems such as pneumonia and atelectasis Multimodal pain management has been suggested, including opioids with their known side effect .

Though Thoracic epidural analgesia was considered as the gold standard for post-thoracotomy pain management, it is not used nowadays for thoracotomy pain because it is associated with high potential risks of dural puncture, nerve lesions, epidural hematoma, and hypotension .

Paravertebral block has gained more popularity than other regional analgesic techniques including caudal and epidural for perioperative analgesia in thoracic surgery. Thoracic paravertebral block provides adequate postoperative analgesia with favorable adverse effects.

The use of thoracic Paravertebral block in thoracic surgery is associated with decreased pain severity and opioid consumption in both adults and children. TPVB alone has previously been compared with GA alone, much of the literature is heterogeneous and includes landmark techniques at multiple thoracic levels which are time consuming, uncomfortable, and expose the patient to risk with each needle pass. A block from T1-T6 is required for most breast cancer surgeries.

Recently, a newer technique "midpoint transverse process to pleura" block has been described in which the tip of the needle is placed at the midpoint between the transverse process and pleura. Injections of local analgesia are made between the transverse process and the pleura. The local analgesia travels via the fenestrations in the superior costotransverse ligament at the injection level and frequently to adjacent levels, reaching the dorsal and ventral rami in the paravertebral region.

The aim of the study is to compare the analgesic efficacy and safety of midpoint transverse process to pleura to pleural block versus Paravertebral block for post thoracic surgery analgesia.

Being tested
Group A (Thoracic Paravertebral Block ), Group B : thoracic Mid-Point Transverse Process to Pleural Block
Keywords
Thoracic Paravertebral Block, Thoracotomy, Analgesia, thoracic Mid-Point Transverse Process
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group A (Thoracic Paravertebral Block )Drug

    Patients received 20 mL of 0.25% levobupivacaine after the paravertebral space after passing through the superior costotransverse ligament

  • Group B : thoracic Mid-Point Transverse Process to Pleural BlockDrug

    Patients received 20 mL of 0.25% levobupivacaine between the mid-point of the posterior border of the transverse process and the pleura.

Study groups in NCT07799844
Study groupRoleWhat they receive
Group A (Thoracic Paravertebral Block )ExperimentalPatients received 20 mL of 0.25% levobupivacaine after the paravertebral space after passing through the superior costotransverse ligament.
Receives: Drug: Group A (Thoracic Paravertebral Block )
Group B (Mid-Point Transverse Process to Pleural Block )ExperimentalPatients received 20 mL of 0.25% levobupivacaine between the mid-point of the posterior border of the transverse process and the pleura.
Receives: Drug: Group B : thoracic Mid-Point Transverse Process to Pleural Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative pain were assessed using visual analogue scale

    Measured: The postoperative 1hour, 6hours, 12hours, 18hours, and 24 hours.

Secondary outcomes (1)
  1. Postoperative morphine consumption

    Total amount of morphine consumption

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2026
  2. Study start30 Jan 2024
  3. Primary completion30 Sep 2024
  4. Study completion30 Sep 2024

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07799844
Sponsor's protocol ID
36264MS415/11/23
Status last verified
Jan 2024
First submitted
28 Aug 2026
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: It will be available if it needed

Questions about this trial

What is this clinical trial studying?

A study testing Group A (Thoracic Paravertebral Block ) and Group B : thoracic Mid-Point Transverse Process to Pleural Block in people with Thoracotomy Surgery and Analgesia, run by Tanta University at 1 site in Egypt.

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 3 inclusion and 6 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: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 pain were assessed using visual analogue scale (time frame: The postoperative 1hour, 6hours, 12hours, 18hours, and 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 2 Sep 2026.

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