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.
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
- Conditions the study is for
- Thoracotomy Surgery, Analgesia, Thoracic Paravertebral Block
- 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.
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.
- Conditions
- Thoracotomy Surgery, Analgesia, Thoracic Paravertebral Block
- 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 group | Role | What they receive |
|---|---|---|
| Group A (Thoracic Paravertebral Block ) | Experimental | Patients 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 ) | Experimental | Patients 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.
Postoperative pain were assessed using visual analogue scale
Measured: The postoperative 1hour, 6hours, 12hours, 18hours, and 24 hours.
Secondary outcomes (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.
- First posted2 Sep 2026
- Study start30 Jan 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracotomy SurgeryStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ali Mostafa Hagar, Tanta University
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07799844
- Acronym / sponsor ID
- 36264MS415/11/23
- Conditions
- Thoracotomy Surgery, Analgesia, Thoracic Paravertebral Block
- Keywords
- Thoracic Paravertebral Block, Thoracotomy, Analgesia, thoracic Mid-Point Transverse Process
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 2 Sep 2026 (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.
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 .
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Thoracic Paravertebral Block ) | Experimental | Drug: Group A (Thoracic Paravertebral Block )Patients received 20 mL of 0.25% levobupivacaine after the paravertebral space after passing through the superior costotransverse ligament. |
| Group B (Mid-Point Transverse Process to Pleural Block ) | Experimental | Drug: Group B : thoracic Mid-Point Transverse Process to Pleural BlockPatients received 20 mL of 0.25% levobupivacaine between the mid-point of the posterior border of the transverse process and the pleura. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged from 18 to 65 years old
- both sexes, American Society of Anesthesiologists (ASA) classification I \& II
- scheduled for elective thoracotomy.
Key exclusion criteria (6 listed)
- Patient refusal.
- BMI ≥ 35.
- Bleeding diathesis.
- Patients with local anesthetic allergy.
- Neurological disease.
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 |
|---|---|---|
| Group A (Thoracic Paravertebral Block )Patients received 20 mL of 0.25% levobupivacaine after the paravertebral space after passing through the superior costotransverse ligament | Drug | Group A (Thoracic Paravertebral Block ) |
| Group B : thoracic Mid-Point Transverse Process to Pleural BlockPatients received 20 mL of 0.25% levobupivacaine between the mid-point of the posterior border of the transverse process and the pleura. | Drug | Group B (Mid-Point Transverse Process to Pleural Block ) |
Primary outcome
Postoperative pain were assessed using visual analogue scale
Time frame: The postoperative 1hour, 6hours, 12hours, 18hours, and 24 hours.
1 secondary outcome
Postoperative morphine consumption
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Yes. It will be available if it needed
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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.
1 site in 1 country: see every site and its status.
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.